Actively Recruiting
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Led by Kite, A Gilead Company · Updated on 2026-05-12
550
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with relapsed or refractory large B-cell lymphoma as defined by WHO criteria
- Chemorefractory disease or relapse within 12 months after first-line therapy
- Prior therapy including anti-CD20 antibody and anthracycline-containing chemotherapy
- No additional systemic therapy after first-line treatment except steroids or local radiation before leukapheresis
- At least one measurable lesion per IWG Lugano Response Criteria
- At least 2 weeks or 5 half-lives since any prior systemic therapy
- Toxicities from prior therapy recovered to Grade 1 or lower (except nonsignificant toxicities like alopecia)
- ECOG performance status of 2 or less
- Adequate bone marrow, renal, hepatic, cardiac, and pulmonary function as specified
- Females of childbearing potential must have a negative pregnancy test and agree to effective birth control
You will not qualify if you...
- Prior CAR T-cell or other cell-based therapy
- History of other malignancies unless disease-free for at least 3 years or low-grade prostate cancer under watch-and-wait
- Certain lymphoma subtypes excluded, such as Richter's transformation, Burkitt lymphoma, primary CNS lymphoma, among others
- Severe hypersensitivity to aminoglycosides or study agents including fludarabine and cyclophosphamide
- Uncontrolled or IV antimicrobial-requiring infections
- Active hepatitis B or C infection without undetectable viral load
- HIV-positive without appropriate treatment or low CD4 count
- History of CNS disorders, stroke or TIA within 6 months, or active seizure disorders
- Cardiac lymphoma involvement or significant cardiac disease within 6 months
- Secondary CNS lymphoma or full thickness gastrointestinal lymphoma involvement
- Urgent therapy need for oncologic emergency within 4 weeks
- Primary immunodeficiency or recent systemic immunosuppressive therapy affecting T-cell function
- Genetic syndromes causing bone marrow failure
- Medical conditions or residual toxicities affecting safety or efficacy assessments
- Live vaccination within 6 weeks before or during treatment until immune recovery
- Pregnant or breastfeeding females of childbearing potential
- Individuals unwilling to practice effective birth control through 12 months post-treatment
- Inability or unwillingness to comply with study visits and procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
Research Team
M
Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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