A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)
- Registration Number
- NCT04502446
- Lead Sponsor
- CRISPR Therapeutics AG
- Brief Summary
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
- Detailed Description
The study may enroll approximately 45 subjects in total.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 49
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CTX130 CTX130 Administered by IV infusion following lymphodepleting chemotherapy.
- Primary Outcome Measures
Name Time Method Part B (cohort expansion) From CTX130 infusion up to 60 months post-infusion] Objective response rate
Part A (dose escalation) From CTX130 infusion up to 28 days post-infusion Incidence of adverse events
- Secondary Outcome Measures
Name Time Method Progression Free Survival From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months Overall Survival From date of CTX130 until date of death due to any cause, assessed up to 60 months
Trial Locations
- Locations (10)
Research Site 9
🇺🇸New York, New York, United States
Research Site 1
🇺🇸Houston, Texas, United States
Research Site 7
🇨🇦Toronto, Ontario, Canada
Research Site 3
🇦🇺Sydney, New South Wales, Australia
Research Site 2
🇺🇸Duarte, California, United States
Research Site 4
🇺🇸Miami, Florida, United States
Research Site 10
🇺🇸New Haven, Connecticut, United States
Research Site 8
🇺🇸Bronx, New York, United States
Research Site 6
🇺🇸Salt Lake City, Utah, United States
Research Site 5
🇺🇸Stanford, California, United States