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

Lymphoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04637763
• Other study ID #: CB10A
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2021
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Caribou Biosciences, Inc.
• Contact: Socorro Portella, MD
• Phone: 973 866 7567
• Email: clinicaltrials[@]cariboubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• B Cell Lymphoma
• B Cell Non-Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma
• Refractory B-Cell Non-Hodgkin Lymphoma
• Relapsed Non Hodgkin Lymphoma

Intervention

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

Drug:
• Cyclophosphamide
Chemotherapy for lymphodepletion
• Fludarabine
Chemotherapy for lymphodepletion

Locations

Country	Name	City	State
Australia	Epworth Healthcare	Richmond	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Israel	Hadassah Medical Center	Jerusalem
Israel	Rabin Medical Center	Petah Tikva
Israel	Tel Aviv Medical Center	Tel Aviv
United States	Bone and Marrow Transplant Group of Georgia	Atlanta	Georgia
United States	Georgia Cancer Center at Augusta University	Augusta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Ohio State University James Cancer Hospital	Columbus	Ohio
United States	Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	MD Anderson Cancer Center	Houston	Texas
United States	Holden Comprehensive Cancer Center at the University of Iowa	Iowa City	Iowa
United States	University of California San Diego Moores Cancer Center	La Jolla	California
United States	University of Kentucky Markey Cancer	Lexington	Kentucky
United States	Norton Cancer Institute	Louisville	Kentucky
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Atlantic Health System	Morristown	New Jersey
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Nyu Langone Health	New York	New York
United States	Chao Family Comprehensive Cancer Center/University of California Irvine	Orange	California
United States	Advent Health	Orlando	Florida
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah
United States	HonorHealth	Scottsdale	Arizona
United States	Swedish Cancer Institute	Seattle	Washington
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Caribou Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome measures number of patients with dose-limiting toxicities (Part A).	Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.	28 days following CB-010 infusion
Primary	Primary outcome evaluates tumor response (Part B)	The primary endpoint is objective response rate.	Up to 12 months