A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL)

Korábbi kezelés

• 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.
• Treatment with any prior anti-CD79a therapy.
• Previous history of an allogeneic bone marrow transplantation. Autologous stem cell transplantation (ASCT) is permitted.

Más betegség

• Active autoimmune disease requiring systemic immunosuppressive and/or cytotoxic therapy within the past two years.

Egyéb

• Primary central nervous system (CNS) lymphoma or a history or presence of clinically relevant CNS pathology.

• ≥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:
  • DLBCL (germinal center B cell [GCB] or activated B cell [ABC] type or not otherwise specified [NOS])
  • HGBCL (with MYC and BCL2 and/or BCL6 rearrangements or NOS)
  • PMBCL
  • FL 3b
  • 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.