A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years.
• Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
• Eastern Cooperative Oncology Group performance status 0 or 1.
• Adequate renal, liver, cardiac and pulmonary organ function.
• Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.
Locations
United States
California
Research Site 3
RECRUITING
Duarte
Illinois
Research Site 7
RECRUITING
Chicago
Massachusetts
Research Site 6
RECRUITING
Boston
Missouri
Research Site 2
RECRUITING
St Louis
North Carolina
Research Site 4
RECRUITING
Durham
Tennessee
Research Site 1
RECRUITING
Nashville
Texas
Research Site 5
RECRUITING
Houston
Contact Information
Primary
Central Trials
MedicalAffairs@crisprtx.com
+1 (877) 214-4634
Time Frame
Start Date: 2023-03-13
Estimated Completion Date: 2030-05
Participants
Target number of participants: 250
Treatments
Experimental: CTX131
Administered by IV infusion following lymphodepleting chemotherapy.
Related Therapeutic Areas
Sponsors
Leads: CRISPR Therapeutics AG