Clinical Trial

Disease: Relapsed or Refractory Solid Tumors, (NCT05795595)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumours are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours.

The word tumor does not always imply cancer. In discussing tumors that are malignant (cancerous), however, the term solid tumor is used to distinguish between a localized mass of tissue and leukemia.

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.

Frequency:
More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
Official title:
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors
Who:

Contact

Study Director: Alissa Keegan, MD, PhD


Central Trials

Phone: +1 (877) 214-4634

Email: MedicalAffairs@crisprtx.com

 

Sponsor:

CRISPR Therapeutics AG

Partners:
Locations:

United States, California 
Research Site 3, Duarte, California, United States, 91010

United States, Massachusetts 
Research Site 6, Boston, Massachusetts, United States, 02215

United States, Missouri 
Research Site 2, Saint Louis, Missouri, United States, 63110

United States, North Carolina 
Research Site 4, Durham, North Carolina, United States, 27710

United States, Tennessee 
Research Site 1, Nashville, Tennessee, United States, 37203

United States, Texas 
Research Site 5, Houston, Texas, United States, 77030

Study start:
Apr. 1, 2023
Enrollment:
250 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Knock-out and knock-in
Gene:
Regnase-1 and TGFBR2 double knock-out TRAC (T-cell receptor) knock-out to prevent graft-vs-host disease (GvHD) B2M knock-out (MHC class I to reduce T-cell mediated rejection) CD70 knock-out (to eliminate fratricide and increase potency) Site-specific CAR (CD70-directed) insertion at the TRAC locus
Delivery method:
Adeno-associated virus - Ex-vivo
Trial link:
https://classic.clinicaltrials.gov/ct2/show/NCT05795595
Safety updates:

(29-05-2023) CTX112 and CTX131: Next-generation CRISPR/Cas9-engineered allogeneic (allo) CAR T cells incorporating novel edits that increase potency and efficacy in the treatment of lymphoid and solid tumors (conference abstract for American Association for Cancer Research Annual Meeting 2023)

(14-03-2023) CRISPR Therapeutics to Present at the American Association for Cancer Research 2023 Annual Meeting

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

Status: Active recruiting

Description

An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells 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: Jan. 13, 2024
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