CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma

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)

Sponsors

Lead Sponsor: Caribou Biosciences, Inc.

Source Caribou Biosciences, Inc.
Brief Summary

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.

Detailed Description

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.

Overall Status Not yet recruiting
Start Date December 2020
Completion Date September 2025
Primary Completion Date August 2025
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Primary outcome measures number of patients with dose-limiting toxicities (Part A). 28 days following CB-010 infusion
Primary outcome evaluates tumor response (Part B) Up to 12 months
Enrollment 50
Condition
Intervention

Intervention Type: Genetic

Intervention Name: CB-010

Description: CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

Intervention Type: Drug

Intervention Name: Cyclophosphamide

Description: Chemotherapy for lymphodepletion

Intervention Type: Drug

Intervention Name: Fludarabine

Description: Chemotherapy for lymphodepletion

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Cherry Thomas, MD

Phone: 510-926-9893

Email: [email protected]

Verification Date

November 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Dose Escalation of CB-010

Type: Experimental

Description: Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Label: Expansion of CB-010

Type: Experimental

Description: Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Patient Data Undecided
Study Design Info

Allocation: Non-Randomized

Intervention Model: Sequential Assignment

Intervention Model Description: The CB10A clinical study consists of 3 + 3 design with three dose levels.

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov