Evaluating a new CAR-T cell therapy for advanced solid tumors with CDH17 expression

A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of CDH17 CAR-T in Patients with CDH17-positive Advanced Solid Tumors

This study is testing a new CAR-T cell therapy to see if it can help people with advanced solid tumors that have a specific marker called CDH17.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (Academic / other)
• Drugs / interventions: CAR-T, radiation, chimeric antigen receptor, cyclophosphamide, fludarabine
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT06820424 on ClinicalTrials.gov

What this trial studies

This study is an open-label, single-arm trial aimed at assessing the safety and preliminary efficacy of anti-CDH17 CAR-T cell therapy in patients with advanced solid tumors that express the CDH17 marker. Participants will undergo a leukapheresis procedure to collect T cells, which will then be modified to target CDH17. Following this, patients will receive lymphodepleting therapy before the infusion of the CAR-T cells. The study will monitor the safety and effectiveness of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with CDH17-positive advanced solid tumors who have exhausted standard treatment options.

Not a fit: Patients with tumors that do not express CDH17 or those who are not eligible for lymphodepleting therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that currently have limited effective therapies.

How similar studies have performed: While CAR-T therapies have shown promise in hematological malignancies, this specific approach targeting CDH17 in solid tumors is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Kunming, Yunnan

• Sanbin Wang — Kunming, Yunnan, China (Recruiting)

Study contacts

• Principal investigator: Sanbin Wang, MD — Principal Investigator Sanbin Wang 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
• Study coordinator: Sanbin Wang, MD

Conditions CDH17-positive Advanced Solid Tumors; CDH17 CAR-T