Study on the Safety and Effectiveness of CTX131 for Adults with Returning or Hard-to-Treat Solid Tumors
Sponsor: CRISPR Therapeutics AG
ClinicalTrials ID:NCT05795595
This clinical trial is testing a new treatment called CTX131 to see if it is safe and effective for adults with solid tumors that have come back or are difficult to treat. The study is being conducted at multiple locations and involves participants who have not responded to previous treatments.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment called CTX131 in adults with solid tumors that have either returned after treatment or are difficult to treat. CTX131 is a type of immunotherapy that uses specially modified immune cells to target cancer cells. The study is open-label, meaning both the researchers and participants know what treatment is being given, and it is being conducted at several different medical centers.
Description
This study is testing a new treatment called CTX131, which is a type of immunotherapy designed to target and attack cancer cells in people with solid tumors that have returned or are hard to treat. CTX131 uses a special technology called CRISPR-Cas9 to modify immune cells outside the body, making them better at finding and destroying cancer cells. The study is being conducted at multiple locations and is divided into two phases to assess both the safety and effectiveness of the treatment. Participants will receive CTX131 and be monitored closely to see how well the treatment works and if there are any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a type of cancer that cannot be removed by surgery or has spread, including kidney, cervical, pancreatic, esophageal cancers, or malignant pleural mesothelioma.
- Be in good overall health, with a performance status that allows for normal activity or some restriction in strenuous activities.
- Have good kidney, liver, heart, and lung function.
- Agree to use effective birth control during the study and for 12 months after receiving CTX131, if of childbearing potential.
Exclusion Criteria
- Have previously been treated with medications targeting CD70.
- Have a history of certain brain, heart, or lung conditions.
- Have an uncontrolled infection caused by bacteria, viruses, or fungi.
- Have active infections like HIV, hepatitis B, or hepatitis C.
- Have a primary immune deficiency or an active autoimmune disease that requires treatment with steroids or other immune-suppressing medications.
- Be pregnant or breastfeeding.
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