Recruiting
Early Phase 1
Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Therapy in Patients with CDH17-positive Advanced Solid Tumors
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
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)
| Facility | City | Region | Status |
| Sanbin Wang |
Kunming |
Yunnan |
Recruiting |
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