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

Phase 1

Recruiting

• Conditions: Pancreatic Adenocarcinoma; Esophageal Carcinoma; Clear Cell Renal Cell Carcinoma; Cervical Carcinoma; Malignant Pleural Mesothelioma
• Interventions: Biological: CTX131

• Registration Number: NCT05795595
• Lead Sponsor: CRISPR Therapeutics AG

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Study Timeline

• Study Start: 2023-03-13
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25
• Primary Completion: 2030-04
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CTX131	CTX131	Administered by IV infusion following lymphodepleting chemotherapy.

Primary Outcome Measures

Name	Time	Method
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
Phase 1 (Dose Escalation): Incidence of adverse events	From CTX131 infusion up to 28 days post-infusion	Defined as dose-limiting toxicities

Trial Locations

Locations (7)

Research Site 2; 🇺🇸 Saint Louis, Missouri, United States

Research Site 1; 🇺🇸 Nashville, Tennessee, United States

Research Site 3; 🇺🇸 Duarte, California, United States

Research Site 6; 🇺🇸 Boston, Massachusetts, United States

Research Site 7; 🇺🇸 Chicago, Illinois, United States

Research Site 5; 🇺🇸 Houston, Texas, United States

Research Site 4; 🇺🇸 Durham, North Carolina, United States