NCT06383507

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Metastatic Tumor
• Advanced Solid Tumor
• Renal Cell Carcinoma
• Ovarian Cancer
• Cervix Cancer
• Head and Neck Squamous Cell Carcinoma
• Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	CHT101	After lymphodepletion with Fludarabine and Cyclophosphamide, CD70 UCAR T cells were transfused intravenously.

Timeline

• Start date: 2024-04-22
• Primary completion: 2027-04-21
• Completion: 2029-04-21
• First posted: 2024-04-25
• Last updated: 2024-04-25