Kidney Cancer Clinical Trial

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

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.

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Full Description

The study may enroll approximately 107subjects in total.

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Eligibility Criteria

Abbreviated Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

107

Study ID:

NCT04438083

Recruitment Status:

Active, not recruiting

Sponsor:

CRISPR Therapeutics AG

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There are 7 Locations for this study

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Research Site 2
Duarte California, 91010, United States
Research Site 5
Hartford Connecticut, 06520, United States
Research Site 4
Houston Texas, 77030, United States
Research Site 3
Salt Lake City Utah, 84112, United States
Research Site 1
Melbourne Victoria, 3000, Australia
Research Site 6
Toronto Ontario, M5G 2, Canada
Research Site 7
Amsterdam North Holland, 1066, Netherlands

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

107

Study ID:

NCT04438083

Recruitment Status:

Active, not recruiting

Sponsor:


CRISPR Therapeutics AG

How clear is this clinincal trial information?

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