NCT05468190

A Clinical Research About CD70-positive Advanced/Metastatic Solid Tumors Treated by CD70-targeted CAR-T

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

• Status: Unknown
• 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

As a phase I clinical research，this study plans to evaluate the safety and tolerability 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

This is a single-center, double-arm, open-label study. 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

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

Interventions

Type	Name	Description
BIOLOGICAL	CD70 CAR-T cells	Administration method: intravenous infusion； Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
BIOLOGICAL	CD70 CAR-T cells	Administration method: intraperitoneal injection；Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2022-07-17
• Primary completion: 2024-07-17
• Completion: 2025-07-17
• First posted: 2022-07-21
• Last updated: 2023-08-18

Locations

1 site across 1 country: China