Viewing Study NCT06492304



Ignite Creation Date: 2024-07-17 @ 11:40 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06492304
Status: RECRUITING
Last Update Posted: 2024-07-09
First Post: 2024-06-21

Brief Title: A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With RelapsedRefractory Hematologic Malignancies
Sponsor: CRISPR Therapeutics
Organization: CRISPR Therapeutics

Study Overview

Official Title: A Phase 12 Dose Evaluation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells CTX131 in Adult Subjects With RelapsedRefractory Hematologic Malignancies
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is an open label multicenter phase 12 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with RelapsedRefractory Hematologic Malignancies
Detailed Description: The study may enroll up to 290 subjects in total CTX131 is a CD70-directed chimeric antigen receptor CAR T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsedrefractory hematological 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None