A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

CRISPR Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Esophageal Carcinoma; Malignant Pleural Mesothelioma; Pancreatic Adenocarcinoma; Cervical Carcinoma; Clear Cell Renal Cell Carcinoma

Treatments: Biological: CTX131

Study type: Interventional

Funder types: Industry

Identifiers

NCT05795595

CRSP-ONC-005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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19 participants in 1 patient group

CTX131

Experimental group

Description:

Administered by IV infusion following lymphodepleting chemotherapy.

Treatment:

Biological: CTX131