Clinical Trial

Disease: B-cell Non-Hodgkin Lymphoma, 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). B cell lymphoma 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 a type of 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. 

Frequency:
Non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. About 77,240 people (42,380 males and 34,860 females) will be diagnosed with NHL. This includes both adults and children.
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, Arizona

HonorHealth, Scottsdale, Arizona, United States, 85258

 

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, Iowa

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

 

United States, New Jersey

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

 

United States, Ohio

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

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

 

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

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:

(05-04-2023) CRISPR Clinical Trial Updates From Caribou Biosciences

(29-03-2023) Caribou Biosciences Initiates Dose Expansion Portion of CB-010 ANTLER Phase 1 Trial in Second-line LBCL Patients

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

(29-11-2022) Caribou Biosciences Announces the FDA Granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations to CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy

(18-10-22) Caribou Biosciences Presents Case Report on Long-term Follow up of First Patient Dosed in Phase 1 ANTLER Trial at the Lymphoma, Leukemia, & Myeloma Congress 2022

(10-06-22) Caribou Biosciences Reports Positive Additional Data from CB-010 Allogeneic CAR-T Cell Therapy Phase 1 ANTLER Trial at the European Hematology Association (EHA) 2022 Hybrid Congress

(12-05-22) Caribou Biosciences Announces Positive Initial Data for CB-010 Anti-CD19 Allogeneic CAR-T Cell Therapy

(25-04-22) Caribou Biosciences to Share CB-010 Initial Clinical Data at the Upcoming European Hematology Association (EHA) 2022 Hybrid Congress

(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

(08-09-2020) Caribou Biosciences Announces FDA Clearance of its IND for CB-010, an Off-the-shelf Allogeneic Anti-CD19 CAR-T Cell Therapy

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: Jul. 31, 2023
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