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

Trial ID or NCT#

NCT05169489

Status

recruiting iconRECRUITING

Purpose

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - ≥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:
  1. - 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.
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Investigator(s)

David Miklos
David Miklos
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Medical oncologist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Linnea Bjornlund Nichols
650-724-9050

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View on ClinicalTrials.gov