Recruiting

Phase 1

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

Sponsor:

Caribou Biosciences, Inc.

Code:

NCT04637763

Conditions

Lymphoma, Non-Hodgkin

Relapsed Non Hodgkin Lymphoma

Refractory B-Cell Non-Hodgkin Lymphoma

Non Hodgkin Lymphoma

Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CB-010

Cyclophosphamide

Fludarabine

Study Details

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

Study ID

NCT04637763

Start date

May 26, 2021

Status verified date

May, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation of CB-010

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

experimental: Expansion of CB-010

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

Interventions

CB-010

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

Cyclophosphamide

Chemotherapy for lymphodepletion

Fludarabine

Chemotherapy for lymphodepletion

Primary outcome measure

Primary outcome measures number of patients with dose-limiting toxicities (Part A). [ Time Frame: 28 days following CB-010 infusion ]
Primary outcome evaluates tumor response (Part B) [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Socorro Portella, MD

973 866 7567 clinicaltrials@cariboubio.com

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Tracy Kliner

480-256-4739 tracy.kliner@bannerhealth.com

HonorHealth

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Research Nurse Navigator

480-323-1364 clinicaltrials@honorhealth.com

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Francois Chu

520-621-0823 fchu@arizona.edu

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Dr. Cesar Gentille Sanchez

501-686-8274 cgentille@uams.edu

University of California San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92073

Contacts

Michelle Padilla

858-822-5223 mlp002@health.ucsd.edu

University of Southern California, Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

Contacts

Christine Duran

323-865-0371 Duran_c@med.usc.edu

Chao Family Comprehensive Cancer Center/University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Blake Johnson

714-456-3476 blakej@hs.uci.edu

Advent Health

Recruiting

Orlando, Florida, United States, 32803

Contacts

Kristen Wing

407-303-8251 Kristen.Wing@adventhealth.org

Bone and Marrow Transplant Group of Georgia

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Melhem Solh, MD

404-255-1930 msolh@bmtga.com

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Kelly Jenkins

706-721-1206 kejenkins@augusta.edu

Holden Comprehensive Cancer Center at the University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Umar Farooq

319-384-8044 umar-farooq@uiowa.edu

University of Kentucky Markey Cancer

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Yvonne Taul

859-323-7628 Yvonne.Taul@uky.edu

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Tabby Thomas

502-899-3366 StudyStartup@NCIResearch.org

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

LaToya Marshall

617-636-5409 latoya.marshall@tuftsmedicine.org

Hackensack Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Elizabeth McCarthy

412-860-6447 elizabethl.mccarthy@hmhn.org

Atlantic Health System

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Amanda Hall

973-971-5235 Amandamaria.hall@atlantichealth.org

Salome Greene

973-971-6373 salome.geene@atlantichealth.org

Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10461

Contacts

Joel Victor

718-430-8761 jovictor@montefiore.org

Nyu Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

MARK BOND

646-754-7217 Mark.Bond@nyulangone.org

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Eric Clayton

513-751-2273 Eric.Clayton@usoncology.com

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Richard Maziarz, MD

503-494-6345 MAZIARZR@ohsu.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Sunita Nasta

215-614-1846 Sunita.Nasta@pennmedicine.upenn.edu

Michael McNicholas

215-614-1846 Michael.McNicholas@pennmedicine.upenn.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37323

Contacts

Dr. Olalekan Oluwole

615-936-8422 olalekan.oluwole@vanderbilt.edu

Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Tarah Satterfield

214-818-8472 Tarah.Satterfield@BSWHealth.org

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Contacts

Ly Dsouza

713-745-8614 ldsouza@mdanderson.org

Huntsman Cancer Institute at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Erin Peterson

801-587-4655 erin.peterson@hci.utah.edu

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Karen McClain

757-466-8683 Karen.mcclain@usoncology.com

Virginia Commonwealth University (VCU)

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Kristin Lantis

804-628-2341 kllantis@vcu.edu

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Roisin McAndrew

414-805-5447 rmcandrew@mcw.edu

More Information

Sponsor

Caribou Biosciences, Inc.

Last update posted

Mar 24, 2025

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Caribou Biosciences, Inc. on 2025-03-24.