To hear about similar clinical trials, please enter your email below
Trial Title:
A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
NCT ID:
NCT05795595
Condition:
Clear Cell Renal Cell Carcinoma
Cervical Carcinoma
Esophageal Carcinoma
Pancreatic Adenocarcinoma
Malignant Pleural Mesothelioma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Mesothelioma
Mesothelioma, Malignant
Esophageal Neoplasms
Conditions: Keywords:
CAR-T
Allogeneic
Carcinoma
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CTX131
Description:
CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically
modified ex vivo using CRISPR-Cas9 gene editing components)
Arm group label:
CTX131
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).
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site 3
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 7
Address:
City:
Chicago
Zip:
60637
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 6
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 2
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 4
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 1
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site 5
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
March 13, 2023
Completion date:
May 2030
Lead sponsor:
Agency:
CRISPR Therapeutics AG
Agency class:
Industry
Source:
CRISPR Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05795595
