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

Pancreatic Adenocarcinoma Clinical Trial

Official title:

A Phase 1/2, Open-label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed or Refractory Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795595
• Other study ID #: CRSP-ONC-005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 13, 2023
• Est. completion date: May 2030

Study information

• Verified date: April 2024
• Source: CRISPR Therapeutics
• Contact: Central Trials
• Phone: +1 (877) 214-4634
• Email: MedicalAffairs[@]crisprtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Age =18 years.

2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Cervical Carcinoma
• Clear Cell Renal Cell Carcinoma
• Esophageal Carcinoma
• Esophageal Neoplasms
• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant
• Pancreatic Adenocarcinoma

Intervention

Biological:
• CTX131
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Locations

Country	Name	City	State
United States	Research Site 6	Boston	Massachusetts
United States	Research Site 7	Chicago	Illinois
United States	Research Site 3	Duarte	California
United States	Research Site 4	Durham	North Carolina
United States	Research Site 5	Houston	Texas
United States	Research Site 1	Nashville	Tennessee
United States	Research Site 2	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
CRISPR Therapeutics AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 (Dose Escalation): Incidence of adverse events	Defined as dose-limiting toxicities	From CTX131 infusion up to 28 days post-infusion
Primary	Phase 2 (Cohort Expansion): Objective response rate (ORR)	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	From CTX131 infusion up to 60 months post-infusion