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A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)


Description

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.

Trial Eligibility

Inclusion Criteria: * Age greater than or equal to 18 at the time of enrollment * Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care * Eastern Cooperative Oncology Group performance status 0 or 1 * Adequate hematologic, renal, liver, cardiac and pulmonary organ function Exclusion Criteria: * Prior therapy with an anti-CD19 targeting agent * Active or chronic graft versus host disease requiring therapy * Prior allogeneic stem cell transplantation * Central nervous system (CNS) lymphoma, prior CNS malignancy * Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement. * Primary immunodeficiency * Current or expected need for systemic corticosteroid therapy * Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted * Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence * Unwillingness to follow extended safety monitoring

Study Info

Organization

Caribou Biosciences, Inc.


Primary Outcome

Primary outcome measures number of patients with dose-limiting toxicities (Part A).


Outcome Timeframe 28 days following CB-010 infusion

NCTID NCT04637763

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2021-05-26

Completion Date 2025-08

Enrollment Target 72

Interventions

GENETIC CB-010

DRUG Cyclophosphamide

DRUG Fludarabine

Locations Recruiting

University of Alabama at Birmingham

United States, Alabama, Birmingham


Banner MD Anderson Cancer Center

United States, Arizona, Gilbert


HonorHealth

United States, Arizona, Scottsdale


University of Arizona Cancer Center

United States, Arizona, Tucson


University of Arkansas

United States, Arkansas, Little Rock


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