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

NCT ID: NCT06820424

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2028-06-30

Brief 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.

Detailed Description

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.A leukapheresis procedure will be performed to manufacture Anti-CDH17 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-CDH17 CAR-T cells infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the safety and efficacy of CAR-T therapy was evaluated by investigators.

Conditions

CDH17-positive Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-CDH17 CAR-T cells

CDH17 CAR-T is a novel CAR cell therapy for the treatment of advanced solid tumors.

Group Type: EXPERIMENTAL

Anti-CDH17 CAR-T cells infusion

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Bio-gene Technology Co., Ltd

INDUSTRY

Sponsor Role: collaborator

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanbin Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator Sanbin Wang 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

Locations

Sanbin Wang

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sanbin Wang, MD

Role: CONTACT

Sanbin1011@163.com

13187424131

Facility Contacts

Sanbin Wang Wang, MD

Role: primary

Sanbin1011@163.com

13187424131

Other Identifiers

BG-CT-22-013

Identifier Type: -

Identifier Source: org_study_id