NCT05990621

Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urologic Neoplasms

A Single-arm, Open-label, Dose-escalation/Expansion, Early-phase Clinical Study of Anti-CD70 CAR-T Cell Injection in Patients With CD70-positive Advanced Urological Neoplasms

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-CD70 CAR-T cell injection in patients with CD70-positive Advanced Urologic Neoplasms.

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 CAR-T cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-CD70 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-CD70 CAR-T cell injection, and establish recommended phase 2 dose (RP2D).

Conditions

• CD70-positive Advanced Urologic Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD70 CAR-T cells	0.6×106/Kg ～ 5.0×106/Kg; cells will be infused intravenously.

Timeline

• Start date: 2023-07-31
• Primary completion: 2026-01-31
• Completion: 2026-03-31
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: China