Cervical Carcinoma, Clear Cell Renal Cell Carcinoma, Esophageal Carcinoma, Malignant Pleural Mesothelioma, Pancreatic Adenocarcinoma
Conditions
Keywords
CAR-T, Allogeneic, Carcinoma
Brief summary
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
Detailed description
An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).
Interventions
BIOLOGICALCTX131
CTX131 (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
Key Inclusion Criteria: 1. Age ≥18 years. 2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 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 CTX131 infusion. Key
Exclusion criteria
1. Prior treatment with anti-CD70 targeting agents 2. History of certain central nervous system (CNS), cardiac or pulmonary conditions. 3. Presence of uncontrolled bacterial, viral, or fungal infection. 4. Active HIV, hepatitis B virus or hepatitis C virus infection. 5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 6. Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1 (Dose Escalation): Incidence of adverse events | From CTX131 infusion up to 28 days post-infusion | Defined as dose-limiting toxicities |
| Phase 2 (Cohort Expansion): Objective response rate (ORR) | From CTX131 infusion up to 60 months post-infusion | ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology |
Countries
United States
Outcome results
None listed