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


I'm Interested

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.

Official Title

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)

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


Inclusion Criteria:

   - ≥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)

      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.

Exclusion Criteria:

   - 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.


biological: bbT369


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Linnea Bjornlund Nichols

New Trial Alerts

Receive email alerts when trials open to patients.