Clinical Trial

Disease: Non-Hodgkin Lymphoma, NHL, (2018-003916-38)

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. 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 1/2 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:

Head of Regulatory Affairs: Steve Caffé M.D. CRISPR Therapeutics AG

Sponsor:

CRISPR Therapeutics AG

Partners:
Locations:

Australia

Canada

Germany

United States

Study start:
Dec. 30, 2019
Enrollment:
95 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene insertion, gene knock-out
Gene:
T Cell Receptor (TCR); Class I major histocompatibility complex (MHC I)
Delivery method:
Non-viral - Ex-vivo
Trial link:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003916-38/DE/
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 frequencyLinkNon Hodgkin's lymphoma- B cell malignancies informationLinkTop-Line Results from the Phase 1 CARBON Trial of CTX110LinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

Note:
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.
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Ongoing

Description

To assess the safety of escalating doses of CTX110 in subjects with relapsed or refractory B-cell malignancies to determine the recommended Phase 2 dose (RP2D).

Phase 2 (cohort expansion): To assess the efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies, as measured by objective response rate (ORR).

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.

Last updated: Apr. 10, 2022
Source: EU Clinical Trials Register
clinicaltrialsregister.eu
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