Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)Phase 2NCT05020015
A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
A Phase 2 study testing TAK-007 and Chemotherapy Agents in people with Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), run by Takeda at 15 sites in United States.
Trial summary
This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)
- What is being tested?
- TAK-007 and Chemotherapy Agents
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 15 sitesUnited States
- Study dates
- 12 Nov 2021to 20 Dec 2038
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who have a life expectancy ≥12 weeks.
- Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing disease of the following types:
- LBCL, including the following subtypes defined by the World Health Organization (WHO): i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS). ii. High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement iii. HGBL NOS without translocations. iv. DLBCL arising from iNHL including follicular lymphoma (FL) or marginal zone lymphoma (MZL).
- T-cell/histiocyte-rich LBCL. vi. DLBCL associated with chronic inflammation. vii. Epstein-Barr virus-positive DLBCL-NOS. viii. Primary cutaneous DLBCL, leg type. ix. Primary mediastinal large B-cell lymphoma (PMBCL). x. FL Grade 3B. b. iNHL, including the following subtypes defined by the WHO: i. FL Grades 1, 2, 3A. ii. MZL (nodal, extranodal, and splenic).
- Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography (PET) -positive disease per the Lugano classification.
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- Participants who have r/r LBCL or r/r iNHL after ≥2 prior lines of systemic therapy: (Expansion Cohorts 1A and 1B [LBCL 3L+], and 2A [iNHL 3L +]) or r/r LBCL after 1 prior line of systemic therapy (Expansion Cohort 1C [LBCL 2L]):
- Participants with r/r LBCL must have received an anti-CD20 monoclonal antibody (mAb) and an anthracycline containing chemotherapy regimen and failed or be ineligible for high-dose chemotherapy and autologous stem cell transplantation (ASCT).
- Participants with iNHL must have received an anti-CD20 mAb and an alkylating agent (eg, bendamustine or cyclophosphamide).
- Preinduction salvage chemotherapy and ASCT should be considered 1 line of therapy.
- Any consolidation/maintenance therapy after a chemotherapy regimen (without intervening relapse) should be considered 1 line of therapy with the preceding combination therapy. Maintenance antibody therapy should not be considered a line of therapy.
- Single-agent anti-CD20 mAb therapy should not be considered a line of therapy.
- Bridging chemotherapy given just prior to CAR-T cell therapy treatment should be considered one line of therapy together with cell therapy.
- Participants who have received prior CD19-targeting CAR-T cell therapy must have achieved at least a partial response to the most recent CD19-targeting CAR-T cell therapy.
- Participants with 1 prior line of therapy in Part 1 Cohort 1C must have either:
- refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy OR
- relapsed or refractory disease and be ineligible for intensive chemoimmunotherapy and/or high-dose chemotherapy followed by ASCT due to comorbidities and/or age.
- Participants who have adequate bone marrow function defined as follows:
- Absolute neutrophil count >500/μL.
- Platelet count of >50,000/μL at screening. Participants with transfusion-dependent thrombocytopenia are excluded.
- Participants who have adequate renal, hepatic, cardiac, and pulmonary function as defined in the study protocol:
- Estimated glomerular filtration rate (GFR; Modification of Diet in Renal Disease equation [MDRD]) ≥30 mL/min.
- Serum alanine aminotransferase/aspartate aminotransferase ≤5 times the upper limit of normal range (ULN), as long as participant is asymptomatic.
- Total bilirubin ≤2 mg/dL. Participants with Gilbert's syndrome may have a bilirubin level >2 × ULN, per discussion between the investigator and the medical monitor.
- Left ventricular ejection fraction (LVEF) ≥40% as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed within 1 month of determination of eligibility.
- No evidence of clinically relevant pericardial effusion, and no acute clinically significant electrocardiogram (ECG) findings.
- Absence of Grade ≥2 pleural effusion. Grade 1 stable pleural effusions are allowed.
- Baseline oxygen saturation >92% on room air.
- Participants are required to consent to provide either sufficient archived formalin-fixed paraffin embedded (at least 10 unstained slides, ideally 20 unstained slides) or fresh tumor tissue obtained after the last relapse (see laboratory manual for details). Exception may be granted by sponsor medical monitor per discussion with investigator.
Who cannot join
- Participants with total body weight of <40 kg.
- Participants with primary or secondary central nervous system (CNS) involvement by lymphoma. Participants with a history of secondary CNS involvement by lymphoma without evidence of CNS involvement at screening may be included.
- Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma, or transformation from CLL/small lymphocytic lymphoma (Richter transformation).
- Participants with a history of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed gastric cancer) or unless disease free for ≥3 years at screening.
- Participants who have undergone autologous or allogeneic transplant or Chimeric antigen receptor T cells (CAR-T) or Chimeric antigen receptor Natural Killer cells (CAR-NK) therapy within 3 months of planned enrollment. Participants after allogeneic transplant have to be off systemic immunosuppressive therapy and without the evidence of clinically relevant acute or chronic graft-versus-host disease (GvHD) at the time of enrollment.
- Treatment with any investigational products or any systemic anticancer treatment within 14 days or 2 half-lives of the treatment (whichever is longer) before conditioning therapy. For rituximab, a half-life of 22 days should be considered.
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- Participants with active infection, including fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management within 3 days before enrollment.
- Participants with a history or presence of active or clinically relevant CNS disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, severe dementia, cerebellar disease, or any autoimmune disease with CNS involvement. For CNS disorders that recover or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
- Participants with any of the following within 6 months of enrollment: myocardial infarction, cardiac angioplasty or stenting, unstable angina, symptomatic congestive heart failure (ie, New York Heart Association Class II or greater), clinically significant arrythmia (including uncontrolled atrial fibrillation), or any other clinically significant cardiac disease.
- Participants who have received a live vaccine ≤6 weeks before the start of the conditioning regime.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Northside Hospital
Atlanta, Georgia, 30342
Saint Davids South Austin Medical Center
Austin, Texas, 78704
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
Northwestern Memorial Hospital
Chicago, Illinois, 60611
DUHS Duke Blood Cancer Center
Durham, North Carolina, 27705
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics
Miami, Florida, 33136
Columbia University Medical Center
New York, New York, 10032
Thomas Jefferson University Sidney Kimmer Cancer Center, Clinical Research Organization
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University
Portland, Oregon, 97239
Montefiore Medical Center
The Bronx, New York, 10467
MedStar Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
This study has 2 parts.
The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL),
The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL.
Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
Read the detailed description
The product being tested in this study is called TAK-007. TAK-007 is being tested to evaluate the safety and tolerability in adult participants with r/r B-cell NHL. The study will include 2 parts: Part 1 (Dose escalation and dose expansion) and Part 2.
In Part 1, dose escalation cohorts' participants will receive TAK-007 as follows:
Part 1 dose escalation:
- Part 1: Dose escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK (Natural Killer) Cells (±30%)
- Part 1: Dose escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells (±25%)
In Part 1 dose expansion phase, separate expansion cohorts for LBCL and iNHL (Cohorts 1A [LBCL 3L+] and 2A [iNHL 3L+]) and two additional dose expansion cohorts with a multi-dose regimen will be added (i.e., Cohort 1B and 1C) to evaluate more than 1 doses of TAK-007 after a 3-day regimen of lymphodepleting chemotherapy.
Part 1 dose expansion cohorts' participants will receive TAK-007 as follows:
- Part 1: Dose expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study.
- Part 1: Dose expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study.
Based on the data in Part 1, a single TAK-007 dose level will be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D).
Once RP2D is determined, participants will be enrolled in Part 2 of the study in the following cohorts:
- Cohort 1: TAK-007 (LBCL)
- Cohort 2: TAK-007 (iNHL)
This multi-center trial will be conducted worldwide. Part 1 of the study will be conducted in the US, and Part 2 will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic and will enroll in a separate, long-term, follow-up study for continued safety assessments for up to 15 years after TAK-007 administration.
- Being tested
- TAK-007, Chemotherapy Agents
- Keywords
- Drug Therapy, Chimeric antigen receptor, Natural killer cells, Cell therapy, Allogeneic
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-007Biological
TAK-007 intravenous injection.
Chemotherapy AgentsDrug
Fludarabine and cyclophosphamide as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Experimental | Participants received lymphodepleting chemotherapy per day intravenously (IV) for 3 days followed by TAK-007 200×10^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, IV infusion, once on Day 0. Receives: Biological: TAK-007; Drug: Chemotherapy Agents |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0. Receives: Biological: TAK-007; Drug: Chemotherapy Agents |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine recommended phase 2 dose (RP2D). Receives: Biological: TAK-007; Drug: Chemotherapy Agents |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D. Receives: Biological: TAK-007; Drug: Chemotherapy Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Measured: Up to 24 months
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Measured: Up to 24 months
Number of Participants With Notable Changes in Vital Signs
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute [bpm]).
Measured: Up to 24 months
Secondary outcomes (13)
ORR Per Investigator
ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration. CR is defined as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease. PR is defined as ≥50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites; absent/normal, regressed, but no increase in nonmeasured lesion; Spleen must have regressed by >50% in length beyond normal.
Measured: Up to 24 months
Complete Response (CR) Per Investigator
CR is defined per Lugano 2014 criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease.
Measured: Up to 24 months
Duration of Response (DOR) Per Investigator
DOR is defined only for participants who experienced objective response (complete response or partial response) and is the time from the date of first documented objective response to the date of first documented disease progression or death, whichever comes first. Participants not meeting the criteria for progression or death will be censored at the last disease assessment.
Measured: Up to 24 months
Progression-free Survival (PFS) Per Investigator
Progression-free survival is defined as the time from TAK-007 administration to the date of disease progression or death from any cause, whichever comes first. Participants who do not have disease progression or die were censored at the last disease assessment. Participants who do not have postbaseline disease assessment prior to new anticancer therapy (excluding SCT) in the absence of death were censored at the dosing date of TAK-007.
Measured: Up to 24 months
Overall Survival (OS)
OS is defined as the time from TAK-007 administration to the date of death. Participants who did not die were censored at the last contact date.
Measured: Up to 24 months
Cmax - Maximum Observed Blood Concentration of TAK-007
The unit of measure 'copies per microgram' indicates copies of TAK-007 transgene per micrograms of genomic deoxyribonucleic acid (DNA).
Measured: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Tmax - Time of First Occurrence of Cmax of TAK-007
Measured: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007
Measured: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007
The unit of measure 'day*copies/µg' indicates day*copies of TAK-007 transgene per µg of genomic DNA.
Measured: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time
Concentration of IL-15 and soluble immune factors (eg, Interferon (IFN)-gamma (γ) and IL-6) in plasma over time were reported.
Measured: Baseline, pre-dose (Day 0) and post-dose at Days 1, 7, 14, 21, 28 and Months 2,3,4,6,9,12
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration
B-cell aplasia is defined as <50 B-cells per microliters (µl) of blood.
Measured: Pre-dose at Days -5, -4, 0 and post-dose at Days 0, 7, 28 and Months 2, 3, 4, 6, 9, 12
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Measured: Up to 12 months
Percentage of Participants With Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start12 Nov 2021
- Primary completion16 Jun 2024
- Study completion20 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study has 2 Parts: Part 1 is composed of dose escalation followed by dose expansion and Part 2.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020015
- Sponsor's protocol ID
- TAK-007-2001
- Other IDs
- 2021-002086-18
- Status last verified
- Mar 2026
- First submitted
- 20 Aug 2021
- Last updated
- 31 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Multicenter Study of the Safety and Efficacy of TAK-007 in Adult Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05020015
- Acronym / sponsor ID
- TAK-007-2001
- Keywords
- Drug Therapy, Chimeric antigen receptor, Natural killer cells, Cell therapy, Allogeneic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 20 Dec 2038 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Posted 12 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has 2 parts.
The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL),
The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL.
Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.
Detailed description
The product being tested in this study is called TAK-007. TAK-007 is being tested to evaluate the safety and tolerability in adult participants with r/r B-cell NHL. The study will include 2 parts: Part 1 (Dose escalation and dose expansion) and Part 2.
In Part 1, dose escalation cohorts' participants will receive TAK-007 as follows:
Part 1 dose escalation:
- Part 1: Dose escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK (Natural Killer) Cells (±30%)
- Part 1: Dose escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells (±25%)
In Part 1 dose expansion phase, separate expansion cohorts for LBCL and iNHL (Cohorts 1A [LBCL 3L+] and 2A [iNHL 3L+]) and two additional dose expansion cohorts with a multi-dose regimen will be added (i.e., Cohort 1B and 1C) to evaluate more than 1 doses of TAK-007 after a 3-day regimen of lymphodepleting chemotherapy.
Part 1 dose expansion cohorts' participants will receive TAK-007 as follows:
- Part 1: Dose expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study.
- Part 1: Dose expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells on Day 0 of the study.
Based on the data in Part 1, a single TAK-007 dose level will be selected by the sponsor and investigators as the recommended phase 2 dose (RP2D).
Once RP2D is determined, participants will be enrolled in Part 2 of the study in the following cohorts:
- Cohort 1: TAK-007 (LBCL)
- Cohort 2: TAK-007 (iNHL)
This multi-center trial will be conducted worldwide. Part 1 of the study will be conducted in the US, and Part 2 will be conducted worldwide. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic and will enroll in a separate, long-term, follow-up study for continued safety assessments for up to 15 years after TAK-007 administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study has 2 Parts: Part 1 is composed of dose escalation followed by dose expansion and Part 2.
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | Experimental | Biological: TAK-007, Drug: Chemotherapy AgentsParticipants received lymphodepleting chemotherapy per day intravenously (IV) for 3 days followed by TAK-007 200×10^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, IV infusion, once on Day 0. |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Biological: TAK-007, Drug: Chemotherapy AgentsParticipants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0. |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Biological: TAK-007, Drug: Chemotherapy AgentsParticipants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine recommended phase 2 dose (RP2D). |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | Experimental | Biological: TAK-007, Drug: Chemotherapy AgentsParticipants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Participants who have a life expectancy ≥12 weeks.
- Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing disease of the following types:
- Participants who have measurable disease, defined as at least 1 lesion per the Lugano classification. Lesions situated in a previously irradiated area are considered measurable if radiographic progression has been documented in such lesions following completion of radiation therapy. LBCL should have positron emission tomography (PET) -positive disease per the Lugano classification.
- Participants who have r/r LBCL or r/r iNHL after ≥2 prior lines of systemic therapy: (Expansion Cohorts 1A and 1B [LBCL 3L+], and 2A [iNHL 3L +]) or r/r LBCL after 1 prior line of systemic therapy (Expansion Cohort 1C [LBCL 2L]):
Key exclusion criteria (10 listed)
- Participants with total body weight of <40 kg.
- Participants with primary or secondary central nervous system (CNS) involvement by lymphoma. Participants with a history of secondary CNS involvement by lymphoma without evidence of CNS involvement at screening may be included.
- Participants with Burkitt lymphoma, mantle cell lymphoma, lymphoplasmocytic lymphoma, or transformation from CLL/small lymphocytic lymphoma (Richter transformation).
- Participants with a history of malignancy other than nonmelanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast), low-grade tumors deemed to be cured and not treated with systemic therapy (eg, by gastro-endoscopy curatively removed gastric cancer) or unless disease free for ≥3 years at screening.
- Participants who have undergone autologous or allogeneic transplant or Chimeric antigen receptor T cells (CAR-T) or Chimeric antigen receptor Natural Killer cells (CAR-NK) therapy within 3 months of planned enrollment. Participants after allogeneic transplant have to be off systemic immunosuppressive therapy and without the evidence of clinically relevant acute or chronic graft-versus-host disease (GvHD) at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-007TAK-007 intravenous injection. | Biological | Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells, Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells |
| Chemotherapy AgentsFludarabine and cyclophosphamide as per standard of care. | Drug | Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells, Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 24 months
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Number of Participants With Clinically Significant Changes in Laboratory Parameters
Time frame: Up to 24 months
Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Number of Participants With Notable Changes in Vital Signs
Time frame: Up to 24 months
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute [bpm]).
13 secondary outcomes
ORR Per Investigator
Time frame: Up to 24 months
Complete Response (CR) Per Investigator
Time frame: Up to 24 months
Duration of Response (DOR) Per Investigator
Time frame: Up to 24 months
Progression-free Survival (PFS) Per Investigator
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Cmax - Maximum Observed Blood Concentration of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Tmax - Time of First Occurrence of Cmax of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007
Time frame: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time
Time frame: Baseline, pre-dose (Day 0) and post-dose at Days 1, 7, 14, 21, 28 and Months 2,3,4,6,9,12
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration
Time frame: Pre-dose at Days -5, -4, 0 and post-dose at Days 0, 7, 28 and Months 2, 3, 4, 6, 9, 12
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Time frame: Up to 12 months
Percentage of Participants With Positive Replication Competent Retrovirus (RCR) Test Results Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time
Time frame: Up to 60 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-007 and Chemotherapy Agents in people with Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), run by Takeda at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.