This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory Hematologic Malignancies
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 relapsed/refractory 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
Research Site 6
Phoenix, Arizona, United States
Research Site 5
Stanford, California, United States
Research Site 3
Boston, Massachusetts, United States
Research Site 4
New York, New York, United States
Phase 1 Part A (dose escalation) and Part B (dose optimization in selected disease types):
For all cohorts: Incidence of Adverse events defined as dose-limiting toxicities
Time frame: From CTX131 infusion up to 28 days post-infusion
Objective Response rate (ORR)
Phase 2 (expansion of selected Phase 1 disease types)
Time frame: From CTX131 infusion up to 60 months post-infusion
Composite Complete Remission (CRc)
Phase 2 (expansion of selected Phase 1 disease types)
Time frame: From CTX131 infusion up to 60 months post-infusion
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Research Site 2
The Bronx, New York, United States
Research Site 1
Houston, Texas, United States
Research Site 7
East Melbourne, Victoria, Australia