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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05169489
Recruitment Status : Recruiting
First Posted : December 27, 2021
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
2seventy bio

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma (DLBCL) Biological: bbT369 Phase 1 Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 24, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: bbT369 Experimental Arm
Open label, single arm treatment with bbT369
 Biological: bbT369
bbT369 is a genetically modified autologous T cell immunotherapy product consisting of T cells that are transduced with a single lentiviral vector (LVV) to express anti-CD79a and anti-CD20 chimeric antigen receptors (CARs) and transfected with an mRNA encoding the CBLB-targeting megaTAL enzyme to edit the CBLB gene, suspended in a cryopreservative solution.


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Month 24 ]

Secondary Outcome Measures :
  1. Phase 1: Rates of disease-specific response criteria including complete response rate(CRR), partial response rate(PRR), stable disease rate(SDR), and progressive disease rate(PDR) according to the Lugano 2014 response criteria as assessed by Investigator [ Time Frame: Day 1 through Month 24 ]
  2. Phase 1: Overall Response Rate (ORR) according to the Lugano 2014 response criteria as assessed by Investigator [ Time Frame: Day 1 through Month 24 ]
  3. Phase 1: Time to response (TTR) [ Time Frame: Day 1 through Month 24 ]
  4. Phase 1: Time to complete response (TCR) [ Time Frame: Day 1 through Month 24 ]
  5. Phase 1: Time to next treatment for B Cell NHL (TTNT) [ Time Frame: Day 1 through Month 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169489


Contacts
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Contact: Clinical Trials Office 617-798-4270 clinicaltrials@2seventybio.com

Locations
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United States, California
Stanford Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: David Miklos, MD, PhD    650-452-8155    dmiklos@stanford.edu   
United States, Colorado
Colorado Blood Cancer Institute Recruiting
Denver, Colorado, United States, 80218
Contact: Michael Tees, MD    720-754-4800      
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Luis Sanchez-Molina, RN       luis.sanchezmolina@moffitt.org   
United States, Tennessee
Sarah Cannon Recruiting
Nashville, Tennessee, United States, 37203
Contact: Ian Flinn, MD    615-329-7274      
Sponsors and Collaborators
2seventy bio
Investigators
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Study Director: Anna Truppel-Hartmann, MD 2seventy bio, Inc.
More Information
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Responsible Party: 2seventy bio
ClinicalTrials.gov Identifier: NCT05169489    
Other Study ID Numbers: CRC-403
First Posted: December 27, 2021    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 2seventy bio:
CAR T
CART
CAR-T
Cell therapy
Lymphoma
Diffuse large B cell lymphoma (DLBCL)
Primary mediastinal (thymic) large B cell lymphoma (PMBCL)
High-grade B cell lymphoma (HGBCL)
Follicular lymphoma (FL) 3b
DLBCL transformed from FL
 NHL
Non hodgkin's
Dual targeting
Gene edit
T cell
CD20
CD79a
CBLB
Non-hodgkin's
Non-hodgkin
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases