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

NCT04637763 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CB10A
• Study Type: interventional
• Target: 72
• Locations: 3 countries
• Sites: 38

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 outcome evaluates tumor response (Part B)

  The primary endpoint is objective response rate.

  Up to 12 months

Study Arms (2)

Dose Escalation of CB-010

EXPERIMENTAL

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

Genetic: CB-010; Drug: Cyclophosphamide; Drug: Fludarabine

Expansion of CB-010

EXPERIMENTAL

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

Genetic: CB-010; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

CB-010 GENETIC

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

Dose Escalation of CB-010; Expansion of CB-010

Cyclophosphamide DRUG

Chemotherapy for lymphodepletion

Dose Escalation of CB-010; Expansion of CB-010

Fludarabine DRUG

Chemotherapy for lymphodepletion

Dose Escalation of CB-010; Expansion of CB-010

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Caribou Biosciences, Inc.: lead

Study Sites (38)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

TERMINATED

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

HonorHealth

Scottsdale, Arizona, 85258, United States

RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

RECRUITING

University of Arkansas

Little Rock, Arkansas, 72205, United States

RECRUITING

University of California San Diego Moores Cancer Center

La Jolla, California, 92073, United States

RECRUITING

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, 90089, United States

RECRUITING

Chao Family Comprehensive Cancer Center/University of California Irvine

Orange, California, 92868, United States

RECRUITING

Advent Health

Orlando, Florida, 32803, United States

RECRUITING

Bone and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

RECRUITING

Georgia Cancer Center at Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kentucky Markey Cancer

Lexington, Kentucky, 40536, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Hackensack Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Atlantic Health System

Morristown, New Jersey, 07960, United States

RECRUITING

Nyu Langone Health

New York, New York, 10016, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

RECRUITING

Ohio State University James Cancer Hospital

Columbus, Ohio, 43210, United States

TERMINATED

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37323, United States

RECRUITING

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Virginia Commonwealth University (VCU)

Richmond, Virginia, 23219, United States

RECRUITING

Swedish Cancer Institute

Seattle, Washington, 98104, United States

TERMINATED

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Epworth Healthcare

Richmond, Victoria, 3121, Australia

RECRUITING

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

The Sheba Fund for Health Services and Research (R.A.)

Tel Litwinsky, 5265601, Israel

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Socorro Portella, MD

CONTACT

973 866 7567; clinicaltrials@cariboubio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The CB10A clinical study consists of (Part A) 3 + 3 design with three dose levels. (Part B) Expansion portion patients will receive CB-010 at the dose determined in Part A.

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: May 26, 2021
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 24, 2025

Record last verified: 2024-05

Locations

AU (3); IL (4); US (31)