RecruitingPhase 1NCT04637763

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

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)

Sponsor

Caribou Biosciences, Inc.

Enrollment

72 participants

Start Date

May 26, 2021

Study Type

INTERVENTIONAL

Conditions

Lymphoma, Non-Hodgkin Refractory B-Cell Non-Hodgkin Lymphoma Relapsed Non Hodgkin Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ANTLER) is testing an off-the-shelf CAR-T cell therapy — immune cells from a healthy donor that have been genetically edited using CRISPR technology to target and destroy cancer cells expressing the CD19 protein — in adults with B-cell non-Hodgkin lymphoma that has relapsed (come back) or stopped responding to prior standard treatment. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory B-cell non-Hodgkin lymphoma after standard treatment - Your general health score is 0 or 1 (ECOG) - Your heart, kidney, liver, and lung function are adequate **You may NOT be eligible if...** - You have previously received any anti-CD19-targeted therapy - You have had a prior stem cell transplant from a donor (allogeneic) - Your lymphoma has spread to the brain or spinal cord - You have had a seizure, stroke, or dementia - You have a primary immune deficiency - You are currently on steroids or have active thyroid disease (unless controlled) - You have had another cancer in the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICCB-010

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

DRUGCyclophosphamide

Chemotherapy for lymphodepletion

DRUGFludarabine

Chemotherapy for lymphodepletion

Locations(38)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas

Little Rock, Arkansas, United States

University of California San Diego Moores Cancer Center

La Jolla, California, United States

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, United States

Chao Family Comprehensive Cancer Center/University of California Irvine

Orange, California, United States

Advent Health

Orlando, Florida, United States

Bone and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, United States

University of Kentucky Markey Cancer

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Tufts Medical Center

Boston, Massachusetts, United States

Hackensack Medical Center

Hackensack, New Jersey, United States

Atlantic Health System

Morristown, New Jersey, United States

Nyu Langone Health

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States

Swedish Cancer Institute

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Westmead Hospital

Westmead, New South Wales, Australia

Epworth Healthcare

Richmond, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Hadassah Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv Medical Center

Tel Aviv, Israel

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

Tel Litwinsky, Israel

View Full Details on ClinicalTrials.gov

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