Description:
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.
Title
- Brief Title: A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)
- Official Title: A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Advanced, Relapsed or Refractory Renal Cell Carcinoma With Clear Cell Differentiation
Clinical Trial IDs
- ORG STUDY ID:
CRSP-ONC-003
- NCT ID:
NCT04438083
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CTX130 | | CTX130 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CTX130 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. | |
Eligibility Criteria
Abbreviated Inclusion Criteria:
1. Age ≥18 years and body weight ≥60 kg.
2. Unresectable or metastatic RCC that has exploited standard of care treatment.
3. Karnofsky performance status (KPS) ≥80%.
4. Adequate renal, liver, cardiac, and pulmonary organ function.
5. 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 Criteria:
1. Prior treatment with any anti-CD70 targeting agents.
2. Prior treatment with any CAR T cells or any other modified T or natural killer (NK)
cells.
3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. 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.
6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
and/or other immunosuppressive therapy.
7. Prior solid organ transplantation or bone marrow transplant.
8. Pregnant or breastfeeding females.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A (dose escalation): Incidence of adverse events |
Time Frame: | From CTX130 infusion up to 28 days post-infusion |
Safety Issue: | |
Description: | Adverse events defined as dose-limiting toxicities |
Secondary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | From date of CTX130 until date of death due to any cause, assessed up to 60 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | CRISPR Therapeutics AG |
Trial Keywords
- CAR T
- Allogeneic
- Renal cell carcinoma
- Renal cell carcinoma with clear cell differentiation
- CRISPR-Cas9
Last Updated
May 14, 2021