T-ALL/LymphomaPhase 1NCT06909474
Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse/Refractory T-Cell Hematologic Malignancies
A Phase 1 study testing Anti-CD5 CAR NK cells in people with T-ALL/Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T-ALL/Lymphoma
- What is being tested?
- Anti-CD5 CAR NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2025to 31 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:
- T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts/immature lymphocytes and/or flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:
- Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).
- Relapsed within 12 months after achieving CR with first-line induction therapy.
- Failure to achieve CR or relapse after ≥2 lines of chemotherapy.
Show all 18Show fewer
- Relapse after hematopoietic stem cell transplantation (HSCT).
- T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK/T-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia/lymphoma (ATLL), mycosis fungoides/Sézary syndrome (MF/SS) stage IIB or higher), and meets both:
- At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions >1.5 cm in long axis; extranodal lesions >1.0 cm in long axis.
- Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.
- 3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity [MFI] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (>30% tumor cells express CD5).
- 4.ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:
- <!-- -->
- Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.
- Renal: Serum creatinine ≤2.0×ULN.
- Hepatic: ALT/AST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.
- Pulmonary: Oxygen saturation ≥92% (room air). 7.No Contraindications: To leukapheresis, venipuncture, or cell collection. 8.No Severe Psychiatric Disorders. 9.Contraception: Agreement to use effective contraception from informed consent until 1 year post-CAR-NK infusion (for patients of childbearing potential).
- 10.Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.
Who cannot join
- Prior CAR-NK therapy or genetically modified cell therapy.
- Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).
- Recent Anticancer Therapy:
- Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.
- Radiotherapy within 2 weeks prior to screening.
- Active/Uncontrolled Infection: Within 1 week prior to screening.
Show all 21Show fewer
- Cerebrovascular Event or Seizure: Within 6 months prior to screening.
- Viral Infections:
- HBV DNA > ULN (if HBsAg+ or HBcAb+).
- HCV RNA > ULN (if HCV Ab+).
- HIV+, syphilis+, or active tuberculosis.
- Cardiac Disease:
- NYHA Class III/IV congestive heart failure.
- Myocardial infarction or CABG ≤6 months prior.
- Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal/dehydration-related).
- Severe cardiomyopathy.
- Active/Uncontrolled Autoimmune Disease.
- Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal/squamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.
- Live Vaccination: Within 4 weeks prior to screening.
- Pregnancy/Lactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.
- Other: Investigator-determined ineligibility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, 430030
Jia Wei, MD, +86 13986102084 ext. （0351）837 9851, jiawei@tjh.tjmu.edu.cn
About this study
Official title: Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory T-Cell Hematologic Malignancies
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.
Read the detailed description
This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of anti-CD5 CAR-NK therapy for the treatment of patients with relapsed/refractory T-Cell hematologic malignancies. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×10⁷ CAR-positive cells/kg, 3×10⁷ CAR-positive cells/kg, and 5×10⁷ CAR-positive cells/kg. Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. The investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.
- Conditions
- T-ALL/Lymphoma
- Being tested
- Anti-CD5 CAR NK cells
- Keywords
- T-ALL, T-LBL, PTCL-NOS, AITL, ALCL, ENKL, T-PLL, ATLL, MF/SS
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia-Lymphoma, Adult T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD5 CAR NK cellsBiological
Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.
| Study group | Role | What they receive |
|---|---|---|
| CD5 CAR-NK cells | Experimental | Not described Receives: Biological: Anti-CD5 CAR NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.
Measured: 28 dyas
Objective response rate (ORR)
Objective Response Rate (ORR) within 3 Months:
- For patients with T-cell lymphoma, ORR includes complete response (CR) and partial response (PR);
- For patients with T-cell acute lymphoblastic leukemia (T-ALL), ORR includes CR, CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
Measured: 1month, 2 months, 3 months
Overall survival (OS) after CAR-NK infusion
OS is defined as the time from CAR-NK cell infusion to death from any cause, reflecting the long-term survival benefit of the therapy.
Measured: 2 years
Duration of response (DOR) after CAR-NK infusion
DOR measures the time from the first achievement of objective response to disease progression or death, evaluating the durability of treatment efficacy in responding patients.
Measured: 2 years
Progression-Free-Survival (PFS) after CAR-NK infusion
PFS is the time from CAR-NK cell infusion to disease progression or death from any cause, capturing both tumor control and survival outcomes
Measured: 2 years
Secondary outcomes (3)
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Cmax:The highest concentration of CAR T cells amplified in peripheral blood after reinfusion
Measured: 3months
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Tmax:The time to reach the highest concentration of CAR-NK cells in peripheral blood after reinfusion
Measured: 3months
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacodynamics】
The content of free IL-6 in peripheral blood at each time point after transfusion was determined by immunohistochemical method
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start27 Mar 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-ALL/LymphomaStudies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909474
- Sponsor's protocol ID
- PBC083
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory T-Cell Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT06909474
- Acronym / sponsor ID
- PBC083
- Conditions
- T-ALL/Lymphoma
- Keywords
- T-ALL, T-LBL, PTCL-NOS, AITL, ALCL, ENKL, T-PLL, ATLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.
Detailed description
This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of anti-CD5 CAR-NK therapy for the treatment of patients with relapsed/refractory T-Cell hematologic malignancies. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×10⁷ CAR-positive cells/kg, 3×10⁷ CAR-positive cells/kg, and 5×10⁷ CAR-positive cells/kg. Each patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. The investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD5 CAR-NK cells | Experimental | Biological: Anti-CD5 CAR NK cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- -
- 1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:
- T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts/immature lymphocytes and/or flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:
- T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK/T-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia/lymphoma (ATLL), mycosis fungoides/Sézary syndrome (MF/SS) stage IIB or higher), and meets both:
- 3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity [MFI] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (>30% tumor cells express CD5).
Key exclusion criteria (21 listed)
- Prior CAR-NK therapy or genetically modified cell therapy.
- Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).
- Recent Anticancer Therapy:
- Active/Uncontrolled Infection: Within 1 week prior to screening.
- Cerebrovascular Event or Seizure: Within 6 months prior to screening.
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 |
|---|---|---|
| Anti-CD5 CAR NK cellsEach patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion. | Biological | CD5 CAR-NK cells |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 dyas
The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.
Objective response rate (ORR)
Time frame: 1month, 2 months, 3 months
Objective Response Rate (ORR) within 3 Months: 1. For patients with T-cell lymphoma, ORR includes complete response (CR) and partial response (PR); 2. For patients with T-cell acute lymphoblastic leukemia (T-ALL), ORR includes CR, CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
Overall survival (OS) after CAR-NK infusion
Time frame: 2 years
OS is defined as the time from CAR-NK cell infusion to death from any cause, reflecting the long-term survival benefit of the therapy.
Duration of response (DOR) after CAR-NK infusion
Time frame: 2 years
DOR measures the time from the first achievement of objective response to disease progression or death, evaluating the durability of treatment efficacy in responding patients.
Progression-Free-Survival (PFS) after CAR-NK infusion
Time frame: 2 years
PFS is the time from CAR-NK cell infusion to disease progression or death from any cause, capturing both tumor control and survival outcomes
3 secondary outcomes
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Time frame: 3months
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Time frame: 3months
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacodynamics】
Time frame: 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
Related trials for T-ALL/Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-CD5 CAR NK cells in people with T-ALL/Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
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 18 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Wei, MD (+86 13986102084 ext. （0351）837 9851, jiawei@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 28 dyas). The study lists 5 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 3 Apr 2025.