Back to resultsA Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
Primary Purpose
Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTX131
Sponsored by
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring CAR-T, Allogeneic, Carcinoma
Eligibility Criteria
Key Inclusion Criteria: Age ≥18 years. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial carcinoma, and malignant pleural mesothelioma. Eastern Cooperative Oncology Group performance status 0 or 1. Adequate renal, liver, cardiac and pulmonary organ function. 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: Prior treatment with anti-CD70 targeting agents History of certain central nervous system (CNS), cardiac or pulmonary conditions. Presence of uncontrolled bacterial, viral, or fungal infection. Active HIV, hepatitis B virus or hepatitis C virus infection. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. Women who are pregnant or breastfeeding.
Sites / Locations
- Research Site 3Recruiting
- Research Site 2Recruiting
- Research Site 4Recruiting
- Research Site 1Recruiting
- Research Site 5Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CTX131
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Outcomes
Primary Outcome Measures
Phase 1 (Dose Escalation): Incidence of adverse events
Defined as dose-limiting toxicities
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795595
Brief Title
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 13, 2023 (Actual)
Primary Completion Date
April 2030 (Anticipated)
Study Completion Date
May 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CRISPR Therapeutics AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma, Cervical Carcinoma, Esophageal Carcinoma, Pancreatic Adenocarcinoma, Malignant Pleural Mesothelioma
Keywords
CAR-T, Allogeneic, Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTX131
Arm Type
Experimental
Arm Description
Administered by IV infusion following lymphodepleting chemotherapy.
Intervention Type
Biological
Intervention Name(s)
CTX131
Intervention Description
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Primary Outcome Measure Information:
Title
Phase 1 (Dose Escalation): Incidence of adverse events
Description
Defined as dose-limiting toxicities
Time Frame
From CTX131 infusion up to 28 days post-infusion
Title
Phase 2 (Cohort Expansion): Objective response rate (ORR)
Description
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
Time Frame
From CTX131 infusion up to 60 months post-infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Age ≥18 years.
Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial carcinoma, and malignant pleural mesothelioma.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function.
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:
Prior treatment with anti-CD70 targeting agents
History of certain central nervous system (CNS), cardiac or pulmonary conditions.
Presence of uncontrolled bacterial, viral, or fungal infection.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Central Trials
Phone
+1 (877) 214-4634
Email
MedicalAffairs@crisprtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alissa Keegan, MD, PhD
Organizational Affiliation
CRISPR Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Research Site 3
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 2
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 4
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 1
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site 5
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
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