A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy C – Relapsed/Refractory Burkitt Lymphoma (BL)

Ki vehet részt

• •Male or female 18 years of age or older at the time of signing the informed consent
• At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy; •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower; •ECOG performance status score of 0 or 1; •Adequate hematologic and end-organ function; •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
• Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia
• Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:
• Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded
• Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse

Ki nem vehet részt

• •Prior CAR therapy or treatment with any anti-CD19 therapy
• •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
• Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified; •Prior allogeneic stem cell transplant < 3 months prior to screening and/or <4 months prior to planned infusion of brexucabtagene autoleucel; •Presence of active graft-versus-host disease following prior allogeneic stem cell transplant
• •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
• •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL