A Phase 1/2 Study of bbT369, a Dual Targeting CAR T cell Drug Product with a Gene Edit, in Relapsed and/or Refractory B cell Non-Hodgkin s Lymphoma
This is a non-randomized, open label, multi-site Phase 1/2 study. This first-in-human Phase 1/2 Study CRC-403 will evaluate the safety and efficacy of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin's lymphoma (NHL). Phase 1 will be a dose escalation, up to a planned four dose levels. After establishing MTD, Phase 2 will enroll patients with B cell NHL in 2 cohorts: CAR T exposed patients (Cohort 1) and CAR T naïve patients (Cohort 2). A long-term follow-up is planned, in which patients who received bbT369 will be followed for up to 15 years after drug product infusion to evaluate for safety and continued efficacy.
Primary: Determine the maximally tolerated dose (MTD) and/or one or more recommended phase 2 doses (RP2Ds) of bbT369 in subjects with B cell non-Hodgkin s lymphoma (NHL) for use in Phase 2.
Evaluate the safety of the RP2D(s).
Secondary: Provide preliminary data on the efficacy of bbT369 in subjects with B cell NHL
The primary objective of the study is to:
Evaluate the efficacy of bbT369 in subjects with B cell NHL
The secondary objectives of the study are to:
Evaluate the safety of bbT369 in subjects with B cell NHL
Evaluate additional efficacy parameters for bbT369 in subjects with B cell NHL
Assess health-related quality of life in subjects with B cell NHL after treatment with bbT369
At least 8 years of age at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Diagnosis of B-cell NHL according to WHO 2017 classification or WHO 2016 classification where applicable: (1) DLBCL (germinal center B cell [GCB] or activated B cell [ABC] type or not otherwise specified [NOS]) (2) HGBCL (with MYC and BCL2 and/or BCL6 rearrangements or NOS) (3) PMBCL (4) FL 3b (5) DLBCL transformed from FL.
Participants must have relapsed or refractory (r/r) B cell NHL after autologous stem cell transplant (ASCT) or at least 2 prior lines of therapy including an anti-CD20 monoclonal antibody and an anthracycline containing chemotherapy regimen. Note: participants with DLBCL transformed from FL must have r/r disease after ASCT or at least 2 prior therapies following transformation irrespective of therapeutic agents.
At least 1 FDG-avid lesion per Lugano Classification criteria at time of enrollment.
Treatment with any investigational cellular therapy prior to enrollment. Treatment with an approved anti-CD19 CAR T cell therapy in an investigational setting may be permitted after discussion with and approval of the Sponsor.
Progression within 6 weeks of prior anti-CD19 CAR T cell therapy.
Residual toxicities or end-organ damage to vital organs from prior therapy that could put a patient at undue risk based on Investigator's assessment. Toxicities related to prior cytokine release syndrome (CRS) or neurotoxicity must be resolved.
If a patient has received prior anti-CD19 CAR T therapy, development of ≥ Grade 3 CAR T related CRS or ≥ Grade 3 neurotoxicity that in the opinion of the Investigator would cause unacceptable risk of toxicity to the patient upon treatment with bbT369.
Primary central nervous system (CNS) lymphoma or a history or presence of clinically relevant CNS pathology.
Active autoimmune disease requiring systemic immunosuppressive and/or cytotoxic therapy within the past two years.
Treatment with any prior anti-CD79a therapy.
Previous history of an allogeneic bone marrow transplantation. Autologous stem cell transplantation (ASCT) is permitted.
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