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

  • STATUS
    Recruiting
  • End date
    Apr 23, 2027
  • participants needed
    107
  • sponsor
    CRISPR Therapeutics AG
Updated on 23 May 2022
carcinoma
karnofsky performance status

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.

Description

The study may enroll approximately 107subjects in total.

Details
Condition Renal Cell Carcinoma
Treatment CTX130
Clinical Study IdentifierNCT04438083
SponsorCRISPR Therapeutics AG
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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