Renal Cell Carcinoma
Conditions
Keywords
CAR T, Allogeneic, Renal cell carcinoma, Renal cell carcinoma with clear cell differentiation, CRISPR-Cas9
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.
Interventions
BIOLOGICALCTX130
CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
Sponsors
CRISPR Therapeutics AG
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Abbreviated Inclusion Criteria: 1. Age ≥18 years and body weight ≥42 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A (dose escalation): Incidence of adverse events | From CTX130 infusion up to 28 days post-infusion | Adverse events defined as dose-limiting toxicities |
| Part B (cohort expansion): Objective response rate | From CTX130 infusion up to 60 months post-infusion] | Objective response rate per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, Canada, Netherlands, United States
Outcome results
None listed