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

CRISPR Therapeutics AG7 sites in 4 countries19 target enrollmentJune 16, 2020

ConditionsRenal Cell Carcinoma

InterventionsCTX130

DrugsCTX130

Overview

Phase: Phase 1
Intervention: CTX130
Conditions: Renal Cell Carcinoma
Sponsor: CRISPR Therapeutics AG
Enrollment: 19
Locations: 7
Primary Endpoint: Part A (dose escalation): Incidence of adverse events
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

The study may enroll approximately 107subjects in total.

Registry

clinicaltrials.gov

Start Date

June 16, 2020

End Date

October 8, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

CRISPR Therapeutics AG

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

CTX130

Administered by IV infusion following lymphodepleting chemotherapy.

Intervention: CTX130

Outcomes

Primary Outcomes

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

Secondary Outcomes

Progression Free Survival(From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months)
Overall Survival(From date of CTX130 until date of death due to any cause, assessed up to 60 months)