NCT06010875

A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic solid tumors, and obtain recommended doses and infusion patterns.

Detailed description

The research designs to follow 2 groups：Intravenous infusion group and Intraperitoneal injection group；each group sets up 2 phases,the first phase is dose discovery phase to obtain recommended doses,the second phase is dose expansion phase to verify the safety in the recommended doses. In the discovery phase,each group puts up 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.In the dose expansion phase,each group will choose one or two dose groups to verify the safety and efficacy at this dose,and plan to recruit about 6 subjects in each dose group.

Conditions

• Renal Cell Carcinoma
• Ovarian Cancer
• Cervix Cancer
• Metastatic Cancer
• Advanced Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CD70 CAR-T cells	After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
BIOLOGICAL	CD70 CAR-T cells	After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally

Timeline

• Start date: 2023-11-30
• Primary completion: 2025-12-31
• Completion: 2026-09-30
• First posted: 2023-08-25
• Last updated: 2023-11-08

Locations

1 site across 1 country: China