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

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Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Diffuse Large B Cell Lymphoma (DLBCL)

Treatments

Biological: bbT369

Study type

Interventional

Funder types

Industry

Identifiers

NCT05169489

CRC-403

Details and patient eligibility

About

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.

Full description

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 subjects 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 subjects with B cell NHL in 2 cohorts: CAR T exposed subjects (Cohort 1) and CAR T naïve subjects (Cohort 2). A long-term follow-up is planned, in which subjects who received bbT369 will be followed for up to 15 years after drug product infusion to evaluate for safety and continued efficacy.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.