This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.
This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-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
120
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
University of Kansas
Westwood, Kansas, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGSCRI
San Antonio, Texas, United States
RECRUITINGUniversity of Utah
Salt Lake City, Utah, United States
RECRUITINGRoyal Prince Alfred
Camperdown, New South Wales, Australia
RECRUITINGAlfred Health
Melbourne, Victoria, Australia
RECRUITINGSir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
RECRUITINGPhase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Time frame: From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate
Time frame: From CTX112 infusion up to 60 months post-infusion
Duration of Response
Duration of Response (DOR) will only be reported for subjects who have had CR/PR events
Time frame: From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
Duration of Clinical Benefit (DOCB)
Time frame: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
Progression Free Survival
Time frame: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Time frame: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
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