NCT06501183

Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors

Exploratory Study to Evaluate the Safety and Preliminary Efficacy of Anti-CDH17 CAR-T Cell Injection in Patients With CDH17-positive Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Shanghai Pudong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-CDH17 CAR-T cell injection in patients with CDH17-positive advanced malignant solid tumors.

Detailed description

This study will include two parts, dose escalation phase (accelerated titration and 3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by Anti-CDH17 CAR-T cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-CDH17 CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-CDH17 CAR-T cell injection, and establish recommended phase 2 dose (RP2D).

Conditions

• CDH17-positive Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CDH17 CAR-T cells	Anti-CDH17 CAR-T cell injection will be administered intravenously after lymphodepleting.

Timeline

• Start date: 2024-07-08
• Primary completion: 2025-05-30
• Completion: 2026-05-30
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

1 site across 1 country: China