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:07/15/2021
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 Date11/11/2020
- End Date07/31/2022
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
Abbreviated Inclusion Criteria:
- Age ≥18 years and body weight ≥60 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.