Study Comparing KITE-753 and Axicabtagene Ciloleucel for Large B-Cell Lymphoma
This study is comparing two treatments, KITE-753 and axicabtagene ciloleucel, for adults with large B-cell lymphoma (LBCL) that has come back or not responded to previous treatment (relapsed or refractory). Both treatments involve a single infusion of specially modified immune cells (CAR-transduced autologous T cells). Before receiving the main treatment, participants will also receive chemotherapy drugs, fludarabine and cyclophosphamide. The main goal is to see which treatment leads to more participants achieving a complete response (meaning no signs of cancer) after 6 months, and how long participants live without their cancer returning or getting worse (event-free survival) for up to 36 months. You may be able to join if you are 18 or older and have certain types of LBCL that have not responded to your first treatment.
- Study design
- This interventional study plans to enroll 550 participants to compare KITE-753 versus axicabtagene ciloleucel.
- What's involved
- Participants will receive intravenous infusions of fludarabine and cyclophosphamide, followed by a single intravenous infusion of either KITE-753 or axicabtagene ciloleucel.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to measure complete response at 6 months and event-free survival for up to 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07479797
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Recruiting
PHASE3Ages 18+InterventionalTreatmentKite, A Gilead Company
~550 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:KITE-753Axicabtagene CiloleucelFludarabineCyclophosphamide
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of Participants in Complete Response (CR) at Month 6
Measured over Month 6
+1 more outcome measured
Conditions
Where it's being run
14 sites across 11 statesCanada3
California2
Arizona1
Colorado1
Florida1
Georgia1
Illinois1
Missouri1
Study leadership
- Kite Study Director · STUDY_DIRECTOR · Kite, A Gilead Company
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
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.
Exclusion
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.
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.
What this trial measures
- Proportion of Participants in Complete Response (CR) at Month 6Month 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)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).