A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors

Ovarian Cancer Clinical Trial

Official title: A Phase I Clinical Study to Assess the Safety and Efficacy of CD70-targeted CAR-T in the Treatment of CD70-positive Refractory or Relapsed Solid Tumors

Status Not yet recruiting

Clinical Trial Summary

This is a single-center, single-arm ，open-label ，dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.

Clinical Trial Description

In the discovery phase, accelerated titration combined with the "3+3" dose escalation principle was adopted, starting from the initial dose of 3×106/kg. If a grade ≥3 AE occurs during DLT observation, the accelerated titration mode will switch to "3+3" dose escalation, at least 12 eligible patients will be enrolled and receive 4 doses of CD70 UCAR-T cell therapy (3 × 10^6 cells/kg, 6 × 10^6 cells/kg, 8× 10^6 cells/kg, 1 × 10^7 cells/kg).

In the dose expansion phase, each group will choose one or two dose groups to verify the safety and efficacy, and plan to recruit about 6 subjects in each dose group.

During the clinical study, after the completion of each dose group, the Safety Monitoring Committee (SMC) will determine whether it is possible to continue to increase to the next higher dose group, or add more subjects to the current dose group, or reduce to a lower dose group to continue to explore, or climb to a higher dose after reaching the highest dose (1 × 10^7 cells/kg).

Conditions Relapsed Tumor, Refractory Solid Tumor, Renal Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Nasopharyngeal carcinoma, Ovarian Cancer, Cervix Cancer etal ;

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma
• Cervix Cancer
• Head and Neck Squamous Cell Carcinoma
• Metastatic Tumor
• Nasopharyngeal Carcinoma
• Neoplasm Metastasis
• Neoplasms
• Ovarian Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Uterine Cervical Neoplasms

• NCT number: NCT06383507
• Study type: Interventional
• Source: Zhejiang University
• Contact: Weijia Fang, MD
• Phone: 691655
• Email: weijiafang@zju.edu.cn
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 22, 2024
• Completion date: April 21, 2029