A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

Phase 1

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Biological: CTX130

• Registration Number: NCT04438083
• 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 renal cell carcinoma.

Detailed Description

The study may enroll approximately 107subjects in total.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-06-16
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Primary Completion: 2024-10-08
• Study Completion: 2024-10-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Age ≥18 years and body weight ≥42 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

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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.

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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 A (dose escalation): Incidence of adverse events	From CTX130 infusion up to 28 days post-infusion	Adverse events defined as dose-limiting toxicities
Part B (cohort expansion): Objective response rate	From CTX130 infusion up to 60 months post-infusion]	Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1

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 (7)

Research Site 2; 🇺🇸 Duarte, California, United States

Research Site 1; 🇦🇺 Melbourne, Victoria, Australia

Research Site 7; 🇳🇱 Amsterdam, North Holland, Netherlands

Research Site 5; 🇺🇸 Hartford, Connecticut, United States

Research Site 6; 🇨🇦 Toronto, Ontario, Canada

Research Site 4; 🇺🇸 Houston, Texas, United States

Research Site 3; 🇺🇸 Salt Lake City, Utah, United States