Status:
TERMINATED
A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
Lead Sponsor:
CRISPR Therapeutics AG
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 renal cell carcinoma.
Detailed Description
The study may enroll approximately 107subjects in total.
Eligibility Criteria
Inclusion
- Abbreviated
- Age ≥18 years and body weight ≥42 kg.
- Unresectable or metastatic RCC that has exploited standard of care treatment.
- Karnofsky performance status (KPS) ≥80%.
- 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 CTX130 infusion.
- Abbreviated
Exclusion
- Prior treatment with any anti-CD70 targeting agents.
- Prior treatment with any CAR T cells or any other modified T or natural killer (NK) cells.
- History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Previous or concurrent malignancy, except treated with curative approach not requiring systemic therapy and in remission for \>12 months, or any other localized malignancy with low risk of developing into metastatic disease.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Prior solid organ transplantation or bone marrow transplant.
- Pregnant or breastfeeding females.
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04438083
Start Date
June 16 2020
End Date
October 8 2024
Last Update
January 8 2025
Active Locations (7)
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1
Research Site 2
Duarte, California, United States, 91010
2
Research Site 5
Hartford, Connecticut, United States, 06520
3
Research Site 4
Houston, Texas, United States, 77030
4
Research Site 3
Salt Lake City, Utah, United States, 84112