Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
30 participants
Mar 1, 2025
INTERVENTIONAL
Conditions
Summary
This is a single-center, open-label, single-arm study to evaluate the safety and preliminary efficacy of anti-CDH17 CAR-T cells in patients with CDH17-positive advanced solid tumors.
Eligibility
Inclusion Criteria8
- The patient understands and voluntarily signs the informed consent form, and is expected to complete the follow-up examination and treatment of the study procedures;
- Age 18-75 years old, gender unlimited;
- Tumor patients who have positive expression of CDH17 target in tumor tissues measured by immunohistochemistry (IHC) in a laboratory approved by the partner, and have no standard therapy or are ineffective or not suitable for standard treatment;
- Have at least one extracranial measurable lesion according to RECIST 1.1 criteria;
- Estimated survival ≥ 12 weeks;
- Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point;
- The patient has recovered from the toxicity of the prior treatment, i.e., CTCAE toxicity grade < 2 (unless the abnormality is related to the tumor or is stable as judged by the investigator and has little impact on safety or efficacy);
- Venous access could be established; without contraindications of apheresis.
Exclusion Criteria15
- Patients with prior or current other malignancies;
- Presence of brain metastases and clinically significant central nervous system disease;
- Prior antitumor therapy (prior to blood collection for CAR-T preparation) : targeted therapy, epigenetic therapy, or investigational drug therapy within 14 days or at least 5 half-lives, whichever is shorter;
- Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive; HIV antibody positive; CMV DNA titer is higher than the lower limit of detection of the research institution; EBV DNA titer is higher than the lower limit of detection of the research institution
- Those who have a positive sputum smear and T-cell test for tuberculosis infection;
- Patients with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function, both past and present;
- Patients have a severe allergic history;
- Patients with severe heart disease or uncontrollable refractory hypertension;
- Patients with severe liver and kidney dysfunction or consciousness disorders;
- Active autoimmune or inflammatory diseases of the nervous system;
- Uncontrolled infections that need antibiotics treatment;
- Live attenuated vaccine within 4 weeks before screening;
- Alcoholics or persons with a history of drug abuse;
- Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion;
- Any unsuitable to participate in this trial judged by the investigator.
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Interventions
Subiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06820424