Clinical Trials /

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma

NCT04438083

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.

Related Conditions:
  • Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma
  • 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

  • Renal Cell Carcinoma

Interventions

DrugSynonymsArms
CTX130CTX130

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 95 subjects in total.
    

Trial Arms

NameTypeDescriptionInterventions
CTX130ExperimentalAdministered by IV infusion following lymphodepleting chemotherapy.
  • CTX130

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

July 24, 2020