Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

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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.

View Eligibility Criteria

Eligibility Criteria

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:

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.

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05169489

Recruitment Status:

Recruiting

Sponsor:

2seventy bio

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There are 4 Locations for this study

See Locations Near You

Stanford Cancer Institute
Stanford California, 94305, United States More Info
David Miklos, MD, PhD
Contact
650-452-8155
[email protected]
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
Michael Tees, MD
Contact
720-754-4800
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Luis Sanchez-Molina, RN
Contact
[email protected]
Sarah Cannon
Nashville Tennessee, 37203, United States More Info
Ian Flinn, MD
Contact
615-329-7274

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT05169489

Recruitment Status:

Recruiting

Sponsor:


2seventy bio

How clear is this clinincal trial information?

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