Relapsed or Refractory Large B-cell LymphomaPhase 3NCT07479797
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
A Phase 3 study testing KITE-753, Axicabtagene Ciloleucel and Fludarabine in people with Relapsed or Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 42 sites in 9 countries.
Trial summary
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Large B-cell Lymphoma
- What is being tested?
- KITE-753, Axicabtagene Ciloleucel and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 42 sitesin 9 countries
- Study dates
- 22 May 2026to May 2031
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
- World Health Organization (WHO):
- Individuals with chemorefractory disease to first-line therapy (primary refractory disease) that satisfies any of the following criteria:
- Progressive disease (PD) and/or Deauville score of 5 (irrespective of the response designation) as the best response during the first-line treatment or as the end of treatment response following first-line therapy.
- Stable disease (SD) after at least 4 cycles of first-line therapy (eg, 4 cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)).
- PR as best response after at least 6 cycles of first-line therapy (eg, 6 cycles of R-CHOP).
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- Note: A biopsy is recommended to confirm residual disease.
- Individuals with relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease relapsed ≤ 12 months of completion of first-line therapy.
- Note: If the relapse is confirmed by imaging per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma within 12 months, the confirmatory biopsy must be performed within 90 days of the 12-month cutoff.
- Prior therapy must have included an anti-CD20 antibody (including CD20-targeting T-cell engager antibodies) and an anthracycline-containing chemotherapy regimen.
- For individuals with transformed indolent NHL, therapies given for non-transformed disease do not count as a line of therapy for the transformed disease.
- Individuals who have had no additional systemic therapy or holding therapy (except for steroids and/or local radiation) following first-line therapy and prior to leukapheresis are eligible.
- At least 1 measurable lesion according to the IWG Lugano Response Criteria. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. A measurable lesion is defined as >1.5 cm longest transverse diameter (LDi) for lymph node and > 1.0 cm LDi for extranodal lesion. Splenomegaly or hepatomegaly alone in the absence of a measurable lesion is not considered to be measurable disease.
- The following washout period must be satisfied:
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the individual is randomized.
- Toxicities due to immediate prior therapy must have recovered to Grade 1 or lower (except for clinically nonsignificant toxicities such as alopecia, unless otherwise specified in the protocol)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Adequate bone marrow function as evidenced by:
- Absolute neutrophil count ≥ 1,000/μL or ≥ 500/μL if documented bone marrow involvement of lymphoma. Bone marrow involvement by lymphoma is demonstrated by positron emission tomography (PET) scan or bone marrow aspiration or bone marrow biopsy.
- Platelet count ≥ 75,000/μL (unless secondary to bone marrow or spleen involvement by lymphoma, in which platelet count ≥ 50,000 μL is permitted). Bone marrow involvement by lymphoma is demonstrated by PET scan or bone marrow aspiration or bone marrow biopsy. Spleen involvement by lymphoma is demonstrated by PET-diagnostic computed tomography (CT) involvement, splenomegaly, or biopsy.
- Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:
- Creatine clearance (as estimated by Cockcroft-Gault formula) ≥ 30 mL/minute. Note: 24-hour urine estimate is also acceptable.
- Serum alanine aminotransferase/aspartate aminotransferase ≤ 3.0 times the upper limits of normal, except in individuals with documented liver involvement by lymphoma via PET-diagnostic CT scan or biopsy
- Total bilirubin ≤ 1.5 mg/dL, except in individuals with Gilbert's Syndrome or documented liver or pancreatic involvement where ≤ 3.0 times the upper limit of normal is permitted
- Cardiac ejection fraction ≥ 40% and no pericardial effusion Grade 3 or higher (per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0) as determined by an echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) (if ECHO not available at the site). Note: If there is any concern for pericardial effusion, an ECHO must be performed since MUGA alone is not an adequate modality to assess for pericardial effusion.
- No evidence of Grade 2 (per CTCAE v5.0) or greater pleural effusion or ascites (individuals with Grade 1 ascites or pleural effusion are eligible)
- Baseline oxygen saturation > 92% on room air
- Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test (females who have undergone surgical sterilization or have been postmenopausal for at least 2 years before randomization are not considered to be of childbearing potential.
Who cannot join
- Prior CAR T-cell therapy or other cell-based therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without anti-cancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Individuals with asymptomatic localized low-grade prostate cancer for which a watch-and-wait approach is standard of care are eligible.
- Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, T-cell/histiocyte-rich LBCL, mediastinal gray zone lymphoma, plasmablastic lymphoma, intravascular LBCL, primary central nervous system (CNS) lymphoma, primary vitreoretinal LBCL, fibrin-associated LBCL, fluid overload-associated LBCL lymphomatoid granulomatosis, high-grade B-cell lymphoma (HGBCL) with 11q aberrations, anaplastic lymphoma kinase-positive LBCL, LBCL with Interferon Regulatory Factor 4 (IRF4) rearrangement, and transformed from Hodgkin's lymphoma (HL). Note: Individuals with primary testicular LBCL are eligible.
- History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management. Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the individual is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (ie, temperature < 38°C).
- Known history of hepatitis B virus (HBV) (hepatitis B surface (HBs) antigen (HBsAg) positive) infection, or hepatitis C (anti-hepatitis C virus (HCV)) positive) infection. History of a hepatitis B or C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (qPCR) or nucleic acid testing. Note: Individuals who are seropositive for HBV (ie, HBs and/or hepatitis B core antibody positive) are eligible if they are HBsAg-negative and negative for viral DNA. Individuals who are seropositive because of HBV vaccination are eligible (ie, HBs antibody positive, hepatitis core antibody-negative, and HBsAg-negative). Individuals on prophylactic and suppressive antiviral medications against HBV and/or HCV administered per institutional or clinical practice guidelines are eligible.
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- HIV-positive, unless taking appropriate anti-HIV medications, with an undetectable viral load by qPCR and a CD4 count ≥ 200 cells/μL. Note: HIV-positive individuals in Australia are not permitted regardless of active antiretroviral therapy or undetectable blood viral load.
- History or presence of the following CNS disorders: hemorrhage, dementia (per CTCAE v5.0 Grade 2 or higher memory impairment), cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema with confirmed structural defects by appropriate imaging.
- History of stroke or transient ischemic attack within 6 months before enrollment. Individuals with seizure disorders requiring active anticonvulsive medication.
- Individuals with cardiac atrial or cardiac ventricular lymphoma involvement.
- Individuals with secondary CNS lymphoma.
- Individuals with full thickness lymphoma involvement of gastric or intestinal lining. Individuals with concern for gastric or intestinal perforation or known contained perforation.
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active unstable/uncontrolled arrhythmia, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within the 6 months before enrollment.
- Requirement for urgent therapy within 4 weeks before enrollment due to ongoing or impending oncologic emergency (eg, tumor mass effect)
- Presence of primary immunodeficiency.
- History of any medical condition including but not limited to autoimmune disease (eg, Crohn's, rheumatoid arthritis, or systemic lupus) resulting in end organ injury or requiring systemic immunosuppression and/or systemic disease-modifying agents within the last 90 days. Note: At least 90 days or 5 half-lives, whichever is shorter, must have elapsed after any prior immunosuppressive or immunomodulating therapy that impacts T-cell function and before leukapheresis.
- History of concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, or Shwachman-Diamond syndrome.
- Any medical condition or residual toxicities from prior therapies per investigator assessment likely to interfere with the assessments of safety or efficacy of the study treatment.
- History of a severe immediate hypersensitivity reaction or contraindication to any of the agents used in the study (including fludarabine and cyclophosphamide).
- Live vaccine ≤ 6 weeks before randomization, during the treatment period, and until immune recovery following the study treatments (refer to Section 12.10 for additional country-specific requirements, as applicable).
- Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of childbearing potential.
- Individuals of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after the completion of KITE-753 or axi-cel infusion.
- In the investigator's judgment, the individual is unlikely to complete all study-specific visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
42 sites in 9 countries.
42 sites in 9 countries
United States21 sites
St. David's South Austin Medical Center
Austin, Texas, 78704
University of Maryland St. Joseph Medical Center
Baltimore, Maryland, 21201
Novant Health Cancer Institute - Hematology
Charlotte, North Carolina, 28204
University of Illinois
Chicago, Illinois, 60618
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010
Inova Shar Cancer Institute
Fairfax, Virginia, 22031
City of Hope Arizona
Goodyear, Arizona, 85338
West Virginia University
Morgantown, West Virginia, 26506
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06510
Weill Cornell Medicine-NewYork-Presbyterian Hospital
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta
Newnan, Georgia, 30265
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
Stanford University
Stanford, California, 94305
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10467
City of Hope - Chicago
Zion, Illinois, 60099
Spain6 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Institut Catala d'Oncologia
Barcelona, 08908
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Hospital Universitario 12 de Octubre
Madrid, 28041
Clinica Universidad de Navarra
Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca, 37007
Australia3 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Epworth Healthcare
East Melbourne, Victoria, 3002
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
Canada3 sites
Jewish General Hospital
Montreal, H3T 1E2
McGill University Health Centre
Montreal, H4A 0B1
CHU de Québec, Hôpital de l'Enfant-Jésus
Québec, G1R2J6
United Kingdom3 sites
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
University College London Hospital NHS Foundation Trust
London, W1T 7HA
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
Belgium2 sites
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
Japan2 sites
National Cancer Center Hospital
Tokyo, 104-0045
Toranomon Hospital
Tokyo, 105-8470
About this study
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy.
The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
- Being tested
- KITE-753, Axicabtagene Ciloleucel, Fludarabine, Cyclophosphamide
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KITE-753Drug
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
Axicabtagene CiloleucelDrug
A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.
FludarabineDrug
Administered intravenously
CyclophosphamideDrug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Lymphodepleting Chemotherapy: KITE-753 | Experimental | Participants with r/r LBCL will receive the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine and cyclophosphamide.
* A single infusion at a target dose of anti-cluster of differentiation 19 (CD19)/CD20 chimeric antigen receptor (CAR) T cells/kg of KITE-753. Receives: Drug: KITE-753; Drug: Fludarabine; Drug: Cyclophosphamide |
| Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel) | Experimental | Participants with r/r LBCL will receive the following treatment during the study:
* A conditioning chemotherapy regimen of fludarabine and cyclophosphamide.
* A single infusion at a target dose of anti-CD19/CD20 CAR T cells/kg of axi-cel. Receives: Drug: Axicabtagene Ciloleucel; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants in Complete Response (CR) at Month 6
Participants who would be in CR at Month 6 postinfusion of KITE-753 or axi-cel and prior to subsequent anti-lymphoma therapy. This will be assessed by the Lugano Classification by the blinded central assessment.
Measured: Month 6
Event-free survival (EFS)
EFS is defined as the time from randomization to the earliest occurrence of the following EFS events: a) Death due to any cause, b) Disease progression/relapse per blinded central assessment, and c) Initiation of any non-protocol specified subsequent anti-lymphoma therapy for the treatment of residual disease (including stable disease and partial response as per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma).
Measured: Up to 36 months
Secondary outcomes (11)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have achieved either CR or partial response (PR) by the Lugano Classification as determined by blinded central assessment after treatment completion and prior to subsequent anti-lymphoma therapy.
Measured: Up to 36 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to disease progression per the Lugano Classification as determined by blinded central assessment or death from any cause.
Measured: Up to 36 months
Duration of Response (DOR)
DOR is defined as the time from first objective response (CR or PR) prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
Measured: Up to 36 months
Duration of Complete Response (DOCR)
DOCR is defined as the time from first CR prior to subsequent anti-lymphoma therapy to disease progression or death from any cause.
Measured: Up to 36 months
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause.
Measured: Up to 36 months
Percentage of Participants Experiencing Adverse Events (AEs)
Measured: First dose date up to 36 months, plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Measured: First dose date up to 36 months, plus 30 days
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Cancer-30 (EORTC-QLQ-C30)
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, one (1) global health status scale, and one (1) global health-related quality of life (HRQoL). Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status or Global HRQoL scales indicate a higher level of functioning and a better HRQoL respectively, whereas higher scores in symptom scales represent a high level of symptoms.
Measured: Baseline, up to 36 months
Changes From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
The EQ-5D-5L is a standard measure of health-related quality of life. The tool consists of the EQ-5D-5L descriptive part and the EQ visual analogue scale (VAS). The descriptive part comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each of these 5 dimensions has 5 levels (no problem, slight problems, moderate problems, severe problems, and extreme problems). Results for each of the 5 dimensions are combined into a 5-digit number to describe the participant's health state.
The EQ-VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine." Higher scores of EQ VAS indicate better health.
Measured: Baseline, up to 36 months
Changes From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score
The EQ-VAS records the participant's self-rated health on a vertical VAS, where the end points were labeled "the best health you can imagine" and "the worst health you can imagine." The EQ-VAS could be used as a quantitative measure of a health outcome that reflected the participant's own judgment. The EQ-VAS recorded the participant's self-rated health on a vertical VAS, with a score numbered from 0 to 100, where '100 meant the best health you can imagine' and '0 meant the worst health you can imagine".
Measured: Baseline, up to 36 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-Non-Hodgkin's lymphoma (NHL)-Non-Hodgkin Lymphoma High Grade Module 29 (HG29)
The EORTC QLQ-NHL-HG29 is a 29-item patient-reported assessment measuring patients' high-grade NHL-specific symptoms and functioning. The 29 items assess symptom burden due to disease and/or treatment, fatigue/physical condition, neuropathy, emotional impacts, and worries/fears health and functioning. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functional scales indicate a higher level of functioning and a better HRQoL, whereas higher scores in symptom scales represent a higher level of symptoms.
Measured: Baseline, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start22 May 2026
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479797
- Sponsor's protocol ID
- KT-US-740-0603
- Other IDs
- 2025-524403-80-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 13 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
- ClinicalTrials.gov ID
- NCT07479797
- Acronym / sponsor ID
- KT-US-740-0603
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 18 Mar 2026 (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.
The goal of this clinical study is to compare the study drug KITE-753 versus axicabtagene ciloleucel (axi-cel) in adult participants with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after one prior line of therapy.
The primary objective of this study is to evaluate the efficacy of KITE-753 versus axicabtagene ciloleucel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphodepleting Chemotherapy: KITE-753 | Experimental | Drug: KITE-753, Drug: Fludarabine, Drug: CyclophosphamideParticipants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-cluster of differentiation 19 (CD19)/CD20 chimeric antigen receptor (CAR) T cells/kg of KITE-753. |
| Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel) | Experimental | Drug: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: CyclophosphamideParticipants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-CD19/CD20 CAR T cells/kg of axi-cel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below:
- At least 1 measurable lesion according to the IWG Lugano Response Criteria. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. A measurable lesion is defined as >1.5 cm longest transverse diameter (LDi) for lymph node and > 1.0 cm LDi for extranodal lesion. Splenomegaly or hepatomegaly alone in the absence of a measurable lesion is not considered to be measurable disease.
- The following washout period must be satisfied:
- Toxicities due to immediate prior therapy must have recovered to Grade 1 or lower (except for clinically nonsignificant toxicities such as alopecia, unless otherwise specified in the protocol)
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Key exclusion criteria (24 listed)
- Prior CAR T-cell therapy or other cell-based therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, or breast) unless disease-free and without anti-cancer therapy (with the exception of hormonal therapy in the case of breast cancer) for at least 3 years. Individuals with asymptomatic localized low-grade prostate cancer for which a watch-and-wait approach is standard of care are eligible.
- Individuals with the following LBCL fifth edition of WHO criteria subtypes: Richter's transformation of chronic leukemic lymphoma, small lymphocytic lymphoma, Burkitt lymphoma, lymphoplasmacytic lymphoma, T-cell/histiocyte-rich LBCL, mediastinal gray zone lymphoma, plasmablastic lymphoma, intravascular LBCL, primary central nervous system (CNS) lymphoma, primary vitreoretinal LBCL, fibrin-associated LBCL, fluid overload-associated LBCL lymphomatoid granulomatosis, high-grade B-cell lymphoma (HGBCL) with 11q aberrations, anaplastic lymphoma kinase-positive LBCL, LBCL with Interferon Regulatory Factor 4 (IRF4) rearrangement, and transformed from Hodgkin's lymphoma (HL). Note: Individuals with primary testicular LBCL are eligible.
- History of a severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management. Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the individual is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (ie, temperature < 38°C).
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 |
|---|---|---|
| KITE-753A single infusion of CAR-transduced autologous T cells administered as intravenous infusion. | Drug | Lymphodepleting Chemotherapy: KITE-753 |
| Axicabtagene CiloleucelA single infusion of CAR-transduced autologous T cells administered as intravenous infusion. | Drug | Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel) |
| FludarabineAdministered intravenously | Drug | Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel), Lymphodepleting Chemotherapy: KITE-753 |
| CyclophosphamideAdministered intravenously | Drug | Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel), Lymphodepleting Chemotherapy: KITE-753 |
Primary outcome
Proportion of Participants in Complete Response (CR) at Month 6
Time frame: Month 6
Participants who would be in CR at Month 6 postinfusion of KITE-753 or axi-cel and prior to subsequent anti-lymphoma therapy. This will be assessed by the Lugano Classification by the blinded central assessment.
Event-free survival (EFS)
Time frame: Up to 36 months
EFS is defined as the time from randomization to the earliest occurrence of the following EFS events: a) Death due to any cause, b) Disease progression/relapse per blinded central assessment, and c) Initiation of any non-protocol specified subsequent anti-lymphoma therapy for the treatment of residual disease (including stable disease and partial response as per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma).
11 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 36 months
Progression-Free Survival (PFS)
Time frame: Up to 36 months
Duration of Response (DOR)
Time frame: Up to 36 months
Duration of Complete Response (DOCR)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: First dose date up to 36 months, plus 30 days
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: First dose date up to 36 months, plus 30 days
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Cancer-30 (EORTC-QLQ-C30)
Time frame: Baseline, up to 36 months
Changes From Baseline in the 5-level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L) Score
Time frame: Baseline, up to 36 months
Changes From Baseline in the EuroQol Visual Analogue Scale (EQ-VAS) Score
Time frame: Baseline, up to 36 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-Non-Hodgkin's lymphoma (NHL)-Non-Hodgkin Lymphoma High Grade Module 29 (HG29)
Time frame: Baseline, up to 36 months
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 26 Oct 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kite Study Director study director
Kite, A Gilead Company
42 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KITE-753, Axicabtagene Ciloleucel and Fludarabine in people with Relapsed or Refractory Large B-cell Lymphoma, run by Kite, A Gilead Company at 42 sites in 9 countries.
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 28 inclusion and 24 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, Australia, Canada, United Kingdom and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Proportion of Participants in Complete Response (CR) at Month 6 (time frame: Month 6). The study lists 2 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 26 Oct 2026.