This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Research Site 3
Duarte, California, United States
Research Site 7
Chicago, Illinois, United States
Research Site 6
Boston, Massachusetts, United States
Research Site 2
St Louis, Missouri, United States
Phase 1 (Dose Escalation): Incidence of adverse events
Defined as dose-limiting toxicities
Time frame: From CTX131 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate (ORR)
ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology
Time frame: From CTX131 infusion up to 60 months post-infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site 4
Durham, North Carolina, United States
Research Site 1
Nashville, Tennessee, United States
Research Site 5
Houston, Texas, United States