Clinical Trial

Disease: Relapsed or Refractory B-cell Malignancies, (NCT04035434)

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include B-cell lymphomas and leukaemias. While leukaemias typically originate in the bone marrow and spread through the bloodstream, lymphomas usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

There are more than 70 known types of B-cell lymphoma, and these make up approximately 85 % of all cases of non-Hodgkin lymphomas in the United States. NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers. B-cell lymphomas may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Other common types of B-cell lymphoma include:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma
  • Chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphomas
  • Burkitt lymphoma

In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. B-ALL is the most common type of ALL. Note that B-ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

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.


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. ALL accounts for less than 1% of all cancers in the U.S., with 6,540 new cases estimated in the U.S. in 2023.
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)


Clinical Trials

Phone: +1 (877) 214-4634



United States, New York

Roswell Park Cancer Insitute, Buffalo, New York, United States, 14203

Weill Cornell Medical College / New York Presbyterian Hospital, New York, New York, United States, 10021


United States, North Carolina

Duke University, Durham, North Carolina, United States, 27710


United States, California

Cedars Sinai, Los Angeles, California, United States, 90048

UCSF Medical Center, San Francisco, California, United States, 94143


United States, Georgia

Emory University Winship Cancer Institute, Atlanta, Georgia, United States, 30322


United States, Florida

Mayo Clinic, Jacksonville, Florida, United States, 32224


United States, Illinois

University of Chicago, Chicago, Illinois, United States, 60637


United States, Kansas

University of Kansas, Westwood, Kansas, United States, 66205


United States, Kentucky

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


United States, Oregon

Oregon Health and Science University, Portland, Oregon, United States, 97239


United States, Massachusetts

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215


United States, Maryland

University of Maryland, Baltimore, Maryland, United States, 21201


United Statesm Minnesota

University of Minnesota, Minneapolis, Minnesota, United States, 55455


United Statesm Missouri

Washington University, Saint Louis, Missouri, United States, 63130


United States, Texas

Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, Texas, United States, 75390

Texas Transplant Institute, San Antonio, Texas, United States, 78229


United States, Pennsylvania

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States, 19111


United States, Tennessee

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203


United States, Virginia

Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States, 23298


United States, Washington

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


Australia, New South Wales

Royal Prince Alfred Hospital, Sydney, New South Wales, Australia, 2050


Australia, Victoria

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia, 3000


Australia, Western Australia

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia, 6009


Germany, Hamburg

University of Hamburg, Hamburg, Germany, 20148


Canada, Ontario

Princess Margaret Cancer Centre, Toronto, Ontario, Canada, M5G 2M9



Clinica Universidad de Navarra, Pamplona, Navarra, Spain, 31008

Hospital Clínic de Barcelona, Barcelona, Spain, 08036

Hospital Universitario de Salamanca, Salamanca, Spain, 37007

Study start:
Jul. 22, 2019
227 participants
Gene editing method:
Type of edit:
Gene knock-out, gene insertion
TCR alpha constant (TRAC), Major histocompatibility complex I (MHC I) Knock-in of anti-CD19 CAR
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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: Apr. 20, 2024
Source: US National Institutes of Health (NIH)
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