Status:
RECRUITING
Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer
Lead Sponsor:
Guangzhou Bio-gene Technology Co., Ltd
Conditions:
Colorectal Cancer (CRC)
Eligibility:
All Genders
18-70 years
Phase:
NA
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 color...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07152210
Start Date
September 1 2025
End Date
December 31 2028
Last Update
September 3 2025
Active Locations (1)
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1
Dongguan Taixin Hospital
Dongguan, Guangdong, China, 523125