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A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL)
Trial ID: NCT05169489
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.
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 (NHL)
- ≥18 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)
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 subject at undue risk based on Investigator's assessment. Toxicities related to
prior cytokine release syndrome (CRS) or neurotoxicity must be resolved.
- If a subject 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 subject 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.