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

Last updated: March 21, 2025
Sponsor: Caribou Biosciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

Cyclophosphamide

Fludarabine

CB-010

Clinical Study ID

NCT04637763
CB10A
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Age greater than or equal to 18 at the time of enrollment

  • Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after priorstandard of care

  • Eastern Cooperative Oncology Group performance status 0 or 1

  • Adequate hematologic, renal, liver, cardiac and pulmonary organ function

Exclusion

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 orautoimmune disease with CNS involvement.

  • Primary immunodeficiency

  • Current or expected need for systemic corticosteroid therapy

  • Current thyroid disorder. Hypothyroidism controlled with stable hormone replacementis permitted

  • Other malignancy within 2 years of study entry, except curatively treatedmalignancies or malignancies with low risk of recurrence

  • Unwillingness to follow extended safety monitoring

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: Cyclophosphamide
Phase: 1
Study Start date:
May 26, 2021
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Epworth Healthcare

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • Royal Perth Hospital

    Perth, Western Australia 6000
    Australia

    Active - Recruiting

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Tel Aviv Medical Center

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

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

    Tel HaShomer, 5265601
    Israel

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Terminated

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • University of Arkansas

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    La Jolla, California 92073
    United States

    Active - Recruiting

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California 90089
    United States

    Active - Recruiting

  • Chao Family Comprehensive Cancer Center/University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • Advent Health

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Bone and Marrow Transplant Group of Georgia

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Holden Comprehensive Cancer Center at the University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Kentucky Markey Cancer

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Active - Recruiting

  • Hackensack Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Nyu Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Ohio State University James Cancer Hospital

    Columbus, Ohio 43210
    United States

    Terminated

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37323
    United States

    Active - Recruiting

  • Baylor Charles A. Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Active - Recruiting

  • Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Terminated

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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