NCT07152210 Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
| NCT ID | NCT07152210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangzhou Bio-gene Technology Co., Ltd |
| Condition | Colorectal Cancer (CRC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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Brief Summary
This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily participate in this trial, sign the informed consent form. 2. Advanced colorectal cancer patients who have either failed standard treatment, experienced intolerable toxicity, or are unsuitable or unwilling to undergo standard treatment, and voluntarily agree to receive the current treatment. 3. Be able to provide immunohistochemical (IHC) test results from the past 2 years, indicating positive expression of CDH17/GUCY2C targets in tumor tissues. 4. Have at least one extracranial, measurable/assessable lesion according to RECIST 1.1 criteria. 5. Have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1 and an expected survival duration of at least 3 months. 6. Have recovered from the toxicity associated with previous treatments, with a CTCAE toxicity grade of less than 2. 7. Have no significant hematopoietic dysfunction and possess adequate organ function. 8. Be able to meet the research center's requirements for apheresis/perip
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