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

NCT ID: NCT04637763

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-26

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose Escalation of CB-010

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

Group Type EXPERIMENTAL

CB-010

Intervention Type GENETIC

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

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for lymphodepletion

Fludarabine

Intervention Type DRUG

Chemotherapy for lymphodepletion

Expansion of CB-010

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

Group Type EXPERIMENTAL

CB-010

Intervention Type GENETIC

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

Cyclophosphamide

Intervention Type DRUG

Chemotherapy for lymphodepletion

Fludarabine

Intervention Type DRUG

Chemotherapy for lymphodepletion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CB-010

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

Intervention Type GENETIC

Cyclophosphamide

Chemotherapy for lymphodepletion

Intervention Type DRUG

Fludarabine

Chemotherapy for lymphodepletion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Caribou Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status TERMINATED

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status RECRUITING

HonorHealth

Scottsdale, Arizona, United States

Site Status RECRUITING

University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

University of Arkansas

Little Rock, Arkansas, United States

Site Status RECRUITING

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

University of Southern California, Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Chao Family Comprehensive Cancer Center/University of California Irvine

Orange, California, United States

Site Status RECRUITING

Advent Health

Orlando, Florida, United States

Site Status RECRUITING

Bone and Marrow Transplant Group of Georgia

Atlanta, Georgia, United States

Site Status RECRUITING

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Site Status RECRUITING

Holden Comprehensive Cancer Center at the University of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

University of Kentucky Markey Cancer

Lexington, Kentucky, United States

Site Status RECRUITING

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Hackensack Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Atlantic Health System

Morristown, New Jersey, United States

Site Status RECRUITING

Nyu Langone Health

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status RECRUITING

Ohio State University James Cancer Hospital

Columbus, Ohio, United States

Site Status TERMINATED

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status RECRUITING

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States

Site Status RECRUITING

Swedish Cancer Institute

Seattle, Washington, United States

Site Status TERMINATED

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Westmead Hospital

Westmead, New South Wales, Australia

Site Status RECRUITING

Epworth Healthcare

Richmond, Victoria, Australia

Site Status RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Hadassah Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

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

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Socorro Portella, MD

Role: CONTACT

973 866 7567

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tracy Kliner

Role: primary

480-256-4739

Research Nurse Navigator

Role: primary

480-323-1364

Francois Chu

Role: primary

520-621-0823

Dr. Cesar Gentille Sanchez

Role: primary

501-686-8274

Michelle Padilla

Role: primary

858-822-5223

Christine Duran

Role: primary

323-865-0371

Blake Johnson

Role: primary

714-456-3476

Kristen Wing

Role: primary

407-303-8251

Melhem Solh, MD

Role: primary

404-255-1930

Kelly Jenkins

Role: primary

706-721-1206

Umar Farooq

Role: primary

319-384-8044

Yvonne Taul

Role: primary

859-323-7628

Tabby Thomas

Role: primary

502-899-3366

LaToya Marshall

Role: primary

617-636-5409

Elizabeth McCarthy

Role: primary

412-860-6447

Amanda Hall

Role: primary

973-971-5235

Salome Greene

Role: backup

973-971-6373

MARK BOND

Role: primary

646-754-7217

Joel Victor

Role: primary

718-430-8761

Eric Clayton

Role: primary

513-751-2273 ext. 27135

Richard Maziarz, MD

Role: primary

503-494-6345

Sunita Nasta

Role: primary

215-614-1846

Michael McNicholas

Role: backup

215-614-1846

Dr. Olalekan Oluwole

Role: primary

615-936-8422

Tarah Satterfield

Role: primary

214-818-8472

Ly Dsouza

Role: primary

713-745-8614

Erin Peterson

Role: primary

801-587-4655

Karen McClain

Role: primary

757-466-8683

Kristin Lantis

Role: primary

804-628-2341

Roisin McAndrew

Role: primary

414-805-5447

Dr Kenneth Micklethwaite

Role: primary

+61 2 8890 5764

Gillian Huang

Role: backup

+61 2 8890 5448

Dr Costas Yannakou

Role: primary

(03) 9483 3833

Dr Connie Barlas

Role: backup

(03) 95162374

Megan Margaria

Role: primary

+618 9224 1158

Lisa Forsyth

Role: backup

+61 89224 8478

Nurit Ben Shmuel

Role: primary

+972 509508992

Miri Pinhasov

Role: primary

972-3-9377909

Sandrine Harari-Csillag

Role: primary

+972 36973186

Kira Lozinsky

Role: primary

972-3-530-7164

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CB10A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
NCT06090864 RECRUITING PHASE1/PHASE2