Clinical Trial

Disease: B-cell Malignancy; B-cell Lymphoma, Non-Hodgkin Lymphoma, NHL, (NCT04035434)

Disease info:

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. 

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterized 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.

Frequency:
Non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. The American Cancer Society’s estimates for non-Hodgkin’s lymphoma in 2020 are: About 77,240 people (42,380 males and 34,860 females
Official title:
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Who:

Study Director: Ewelina Morawa, MD

Sponsor:

CRISPR Therapeutics AG

Partners:
Locations:

United States, New York

United States, California

United States, Georgia

United States, Florida

United States, Illinois

United States, Kansas

United States, Kentucky

United States, Oregon

United States, Massachusetts

United States, Tennessee

United States, Texas

United States, Pennsylvania

United States, Virginia 

United States, Washington 

Australia, New South Wales

Australia, Victoria

Australia, Western Australia

Germany, Hamburg

Canada, Ontario

Spain, Salamanca 

Spain, Navarra

Spain, Barcelona

Study start:
Jul. 22, 2019
Enrollment:
143 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out, gene insertion
Gene:
TCR alpha constant (TRAC), Major histocompatibility complex I (MHC I) Knock-in of anti-CD19 CAR
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/study/NCT04035434
Safety updates:

(22-11-2021) CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX110™ for the Treatment of Relapsed or Refractory CD19+ B-cell malignancies

(12-10-2021) CRISPR Therapeutics Reports Positive Results from its Phase 1 CARBON Trial of CTX110™ in Relapsed or Refractory CD19+ B-cell malignancies

(21-10-2020) CRISPR Therapeutics Reports Positive Top-Line Results from Its Phase 1 CARBON Trial of CTX110™ in Relapsed or Refractory CD19+ B-cell Malignancies

Other links:

LinkNon Hodgkin's Lymphoma- B cell malignancies informationLinkNon Hodgkin's Lymphoma frequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

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

Status: Active recruiting

Description

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Last updated: May. 11, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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