A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies
Summary
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.
Detailed description
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).
Arms & interventions
- BiologicalCTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Outcome measures
Primary
Phase 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
Secondary
Duration of Response
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
Eligibility criteria
Study locations (4)
University of Kansas
Westwood, Kansas, 66205
Washington University
St Louis, Missouri, 63110
SCRI
San Antonio, Texas, 78229
University of Utah
Salt Lake City, Utah, 84112