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

NCT06820424 | Recruiting Early Phase 1

• 1 other identifier: BG-CT-22-013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

CDH17-positive Advanced Solid Tumors

Keywords

CDH17 CAR-T

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events(AE) after 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.

  within 52 weeks post-infusion

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  within 52 weeks post-infusion

• Concentration of CAR-T cells

  Days 2, 5, 8, 11, 14, 21, 28, 35 and weeks 6, 12, 18, 26, 34, 42, 52 after infusion

• Progression-free survival(PFS)

  within 52 weeks post-infusion

• Overall survival(OS)

  within 52 weeks post-infusion

Study Arms (1)

Anti-CDH17 CAR-T cells

EXPERIMENTAL

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

Biological: Anti-CDH17 CAR-T cells infusion

Interventions

Anti-CDH17 CAR-T cells infusion BIOLOGICAL

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

Anti-CDH17 CAR-T cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China: lead
• Guangzhou Bio-gene Technology Co., Ltd: collaborator

Study Sites (1)

Sanbin Wang

Kunming, Yunnan, 650100, China

RECRUITING

Study Officials

• Sanbin Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanbin Wang, MD

CONTACT

13187424131; Sanbin1011@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CN (1)