This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
CAR T cell naïve and eligible to receive a CD19 CART-cell therapy
Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)
Diffuse large B-cell lymphoma (DLBCL)
Transformations of indolent B-cell lymphomas (excluding Richter's transformation)
Patients ineligible to receive CD19 CAR T-cell therapy
Primary CNS lymphoma
Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)
Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years
Parallel
rondecabtagene autoleucel
Biological/VaccineAn autologous, dual-targeting CD19/20 CAR T-cell candidate.
axicabtagene ciloleucel
Biological/VaccineAn autologous CD19 CAR T-cell therapy
lisocabtagene maraleucel
Biological/VaccineAn autologous CD19 CAR T-cell therapy
Event free survival
The time interval from treatment initiation until the occurrence of a specific event of interest.
Overall Response Rate
Best Overall Response per Lugano Criteria
Complete Response Rate
Complete Response per Lugano Criteria
Progression Free Survial
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Overall Survival
The length of time from either the date of diagnosis or the start of treatment for a disease, that patients diagnosed with the disease, are still alive.
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