Clinical Trial

Disease: Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, B-NHL, (NCT04637763)

Disease info:

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterised by abnormalities of the "B cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. 

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that's used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin. Non-Hodgkin lymphoma is one of the most common cancers in the United States, accounting for about 4% of all cancers.

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

 

Frequency:
B-cell NHL is the most common type of non-Hodgkin lymphoma. NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023.
Official title:
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)
Who:

Contact

Name: Socorro Portella, MD

Phone: 973 866 7567

Email: SPortella@CaribouBio.com

Sponsor:

Caribou Biosciences, Inc.

Partners:
Locations:

United States, Alabama

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233

 

United States, Arizona

HonorHealth, Scottsdale, Arizona, United States, 85258

University of Arizona Cancer Center, Tucson, Arizona, United States, 85724
 

United States, California

University of California San Diego Moores Cancer Center, La Jolla, California, United States, 92073

Chao Family Comprehensive Cancer Center/University of California Irvine, Orange, California, United States, 92868

 

United States, Florida

Advent Health, Orlando, Florida, United States, 32803

 

United States, Georgia 

Bone and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States, 30342

Georgia Cancer Center at Augusta University, Augusta, Georgia, United States, 30912
 

United States, Iowa

Holden Comprehensive Cancer Center at the University of Iowa, Iowa City, Iowa, United States, 52242

 

United States, Kentucky 

University of Kentucky Markey Cancer, Lexington, Kentucky, United States, 40536

Norton Cancer Institute, Louisville, Kentucky, United States, 40207
 

United States, New Jersey

Hackensack Medical Center, Hackensack, New Jersey, United States, 07601

Atlantic Health System, Morristown, New Jersey, United States, 07960

 

United States, New York 

Montefiore Medical Center, Bronx, New York, United States, 10461
 

United States, Ohio

Oncology Hematology Care, Cincinnati, Ohio, United States, 45242

Ohio State University James Cancer Hospital, Columbus, Ohio, United States, 43210

 

United States, Pennsylvania 

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104
 

United States, Texas

Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States, 75246

MD Anderson Cancer Center, Houston, Texas, United States, 77030-4009

 

United States, Utah

Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States, 84112

 

United States, Washington 

Swedish Cancer Institute, Seattle, Washington, United States, 98104



United States, Wisconsin 

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Study start:
May. 26, 2021
Enrollment:
72 participants
Gene editing method:
Cas9 chRDNA (CRISPR hybrid RNA-DNA)
Type of edit:
Gene knock-out, gene knock-in
Gene:
TRAC knockout CD19-specific CAR PD-1 knockout
Delivery method:
Adeno-associated virus (AAV) - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04637763
Safety updates:

(03-09-2024) Caribou Biosciences Announces the FDA has Granted Fast Track Designations to CB-010 in Refractory SLE and to CB-012 in Relapsed or Refractory AML

(13-07-2023) Caribou Biosciences Reports Positive Clinical Data from Dose Escalation of CB-010 ANTLER Phase 1 Trial in r/r B-NHL

(12-12-2022) Caribou Biosciences Reports CB-010 ANTLER Phase 1 Trial Progress 

(12-07-2021) Caribou Biosciences Announces Dosing of First Patient in Phase 1 Clinical Trial Evaluating CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Other links:

LinkB-cell malignancies, non-Hodgkin’s Lymphoma-InformationLinkNon-Hodgkin’s Lymphoma FrequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkGene-Editing Clinical Trial Update

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

CB-010 is manufactured from healthy donor T cells using Caribou’s next-generation CRISPR genome-editing technology. Through genome editing, PD-1 is deleted from the CAR-T cells, which in pre-clinical studies promoted an increase in the durability of antitumour activity. Genome editing is used to remove the endogenous T cell receptor in order to prevent graft-versus-host disease and to site-specifically insert the CAR into the CAR-T genome.

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.

Intervention:

  • Genetic: CB-010

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

  • Drug: Cyclophosphamide

    Chemotherapy for lymphodepletion

  • Drug: Fludarabine

    Chemotherapy for lymphodepletion

Last updated: Sep. 26, 2024
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