Clinical Trial

Disease: Relapsed or Refractory B-Cell Malignancies, (NCT05336409)

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.

Frequency:
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 around 6,540 new cases estimated in 2023.
Official title:
The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
Who:

Contact

Name: Nikolaus Trede

Phone: 888-506-7670

Email: ClinicalTeamCNTY@centurytx.com

Partners:
Locations:

United States, California
University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

University of California San Diego, Moores Cancer Center, San Diego, California, United States, 92093


United States, District of Columbia
Medstar Georgetown University Hospital, Washington, District of Columbia, United States, 20007


United States, Kentucky

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


United States, Michigan

Henry Ford Hospital, Detroit, Michigan, United States, 48202


United States, North Carolina 

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204


United States, Ohio
University of Cincinnati Medical Center, Cincinnati, Ohio, United States, 45229

Oncology Hematology Care, Inc-Kenwood, Cincinnati, Ohio, United States, 45236


United States, Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

United States, Texas

Houston Methodist Research Institute, Houston, Texas, United States, 77030

United States, Virginia
Virginia Oncology Associates, Norfolk, Virginia, United States, 23502


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

Study start:
Jan. 24, 2023
Enrollment:
75 participants
Gene editing method:
CRISPR
Type of edit:
Knockout and knock-in.
Gene:
Knockout of beta-2 microglobulin (b2M) and MHC Class II Transactivator (CIITA) Knock-in of HLA-E, CD19 CAR with FMC63 binder, a truncated Epidermal Growth Factor Receptor (EGFR) containing Cetuximab binding epitope and IL-15.
Delivery method:
- Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.

Last updated: Apr. 29, 2024
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