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Phase I

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

  • Study HIC#:2000027287
  • Last Updated:11/12/2020

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.

  • Start Date11/10/2020
  • End Date07/30/2022

Trial Purpose and Description

Part A (dose escalation): Incidence of adverse events [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]Adverse events defined as dose-limiting toxicities 

Part B (cohort expansion): Objective response rate [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 

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.

Sub-Investigators

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