Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
Clinical Study Evaluating the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
Guangzhou Bio-gene Technology Co., Ltd
20 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- Voluntarily participate in this trial, sign the informed consent form.
- 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.
- Be able to provide immunohistochemical (IHC) test results from the past 2 years, indicating positive expression of CDH17/GUCY2C targets in tumor tissues.
- Have at least one extracranial, measurable/assessable lesion according to RECIST 1.1 criteria.
- Have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1 and an expected survival duration of at least 3 months.
- Have recovered from the toxicity associated with previous treatments, with a CTCAE toxicity grade of less than 2.
- Have no significant hematopoietic dysfunction and possess adequate organ function.
- Be able to meet the research center's requirements for apheresis/peripheral blood collection upon successful screening, or have acceptable stored blood cell separation products available.
Exclusion Criteria18
- Patients who have had or currently have other malignant tumors within the past five years.
- Presence of brain metastasis.
- History of clinically significant central nervous system disorders, either in the past or at screening.
- Imaging indicating tumor invasion of major blood vessels or indistinct borders with blood vessels.
- Individuals who have received cytotoxic drugs or other interventions, assessed by the investigator as potentially impacting lymphocyte expansion, within 14 days or at least five half-lives (whichever is shorter) prior to blood collection for CAR-T preparation.
- Presence of other viremias.
- History of severe allergies.
- Patients with severe cardiac disease.
- Patients with severe hepatic and renal dysfunction or disorders of consciousness.
- Patients with active autoimmune or inflammatory diseases.
- Patients with objective evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonia, severe lung function impairment, etc.
- Patients who have undergone or are awaiting organ transplantation.
- Infections requiring intravenous antibiotic therapy for control or are uncontrollable.
- Individuals who have received live (attenuated) virus vaccines within four weeks prior to screening.
- Alcoholics or individuals with a history of substance abuse.
- Pregnant or lactating women.
- Individuals who have participated in other clinical trials involving drugs within the past 30 days.
- Patients who, based on the investigator's judgment and/or clinical standards, have contraindications to any study procedures or present other medical conditions that may pose unacceptable risks.
Interventions
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07152210