NCT06586658

Anti-CD70-CAR-T Cell Injection for the Treatment of Locally Advanced or Relapsed/Metastatic CD70+ Inoperable Renal Cells

An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD70-CAR-T Cell Injection in Patients With Locally Advanced or Relapsed/Metastatic Renal Cell Carcinoma With CD70+ Inoperable

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable.

Detailed description

This is an investigator-initiated trial to evaluate the role of anti-CD70-CAR T cells in locally advanced or recurrent/metastatic renal cell carcinoma that is inoperable Study intervention consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when the last participant finishes the visit of 12 weeks after CAR-T cells infusion.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD70-CAR-T cells	The subjects received infusions of anti-CD70 CART cells following completion of lymphodepleting preconditioning chemotherapy. Dosage: 3×10\^6 cells/Kg; 1×10\^7 cells/Kg; 2×10\^7 cells/Kg.

Timeline

• Start date: 2024-09-06
• Primary completion: 2027-07-16
• Completion: 2027-07-16
• First posted: 2024-09-19
• Last updated: 2024-10-22

Locations

1 site across 1 country: China