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Recruiting Early Phase 1

Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors

NCT06820424 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2025-03
Last updated
2025-02-11

Condition(s) studied

CDH17-positive Advanced Solid Tumors

Investigational drug(s) / intervention(s)

Anti-CDH17 CAR-T cells infusion

Anti-CDH17 CAR-T cells infusion: Subiects who meet the enrollment conditions will receive intravenous infusion of anti-CDH17 CAR-T Cells after lymphodepleting therapy.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Age 18-75 years old, gender unlimited; 3. 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; 4. Have at least one extracranial measurable lesion according to RECIST 1.1 criteria; 5. Estimated survival ≥ 12 weeks; 6. Baseline ECOG (Eastern Cooperative Oncology Group) score ≤ 1 point; 7. 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); 8. Venous access could be established; without contraindications of apheresis. Exclusion Criteria: 1. Patients with prior or current other malignancies; 2. Presence of brain metastases and clinically significant central nervous system disease; 3. 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; 4. 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 5. Those who have a positive sputum smear and T-cell test for tuberculosis infection; 6. 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; 7. Patients have a severe allergic history; 8. Patients with severe heart disease or uncontrollable refractory hypertension; 9. Patients with severe liver and kidney dysfunction or consciousness disorders; 10. Active autoimmune or inflammatory diseases of the nervous system; 11. Uncontrolled infections that need antibiotics treatment; 12. Live attenuated vaccine within 4 weeks before screening; 13. Alcoholics or persons with a history of drug abuse; 14. Pregnant or Lactating Women; Patients and his or her spouse have a fertility plan within two years after CAR-T cell infusion; 15. Any unsuitable to participate in this trial judged by the investigator.

Primary outcome measure(s)

  • Incidence of adverse events(AE) after infusion — within 52 weeks post-infusion
    The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome are graded by American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

Trial sites (1)

FacilityCityRegionStatus
Sanbin Wang Kunming Yunnan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06820424 on ClinicalTrials.gov ↗ ← All trials in China