Disease: B-cell Malignancy; Non-Hodgkin Lymphoma; B-cell Lymphoma

Disease info:

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 1/2 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
Who:

Study Director: Ewelina Morawa, MD

Partners:
Locations:

United States, Illinois

United States, Kansas

United States, Oregon

United States, Tennessee

Australia, New South Wales

Australia, Victoria

Study start:
Jul. 22, 2019
Enrollment:
95 participants
Gene editing method:
CRISPR-Cas9
Gene:
CRISPR-Cas9 to insert a chimeric antigen receptor (CAR) construct with CD19 and disrupt two genes: The T cell receptor (TCR) and the class I major histocompatibility complex (MHC I) respectively.
Vector:
No information
IndicatorIndicator
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 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

CTX110 CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.

CTX110 is an allogeneic CRISPR-Cas9 gene-edited CAR-T cell therapy targeting CD19 for the treatment of CD19+ malignancies.