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.

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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
Marissa Folsom
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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