NCT05128786

CCT301-38 CAR-T in Patients With Relapsed or Refractory AXL Positive Sarcomas

A Phase I Trial to Assess Safety, Tolerability and Anti-tumor Activity of Autologous T Cell Modified Chimeric Antigen Receptor (CAR) (CCT301-38) in Patients With Relapsed or Refractory AXL Positive Sarcomas

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shanghai PerHum Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is to investigate the safety and tolerability of CCT301-38 CAR modified autologous T cells (CCT301-38) in subjects with relapsed or refractory AXL positive sarcomas

Detailed description

This study is an open label, single-center Phase I dose escalation trial to assess the safety, tolerability, DLT and MTD of CCT301-38 cell therapy in patients with AXL positive relapsed or refractory sarcomas. Subjects that meet inclusion criteria with positive AXL biopsy (IHC 1+ or greater in ≥50% tumor cells) will receive CCT301-38 according to the 3+3 dose escalation design.

Conditions

• SAR

Interventions

Type	Name	Description
BIOLOGICAL	CCT301-38	Blood will be collected from subjects to isolate peripheral blood mononuclear cells for the production of CCT301-38. Subjects will receive the conditioning chemotherapy regimen of cyclophosphamide and fludarabine for lymphodepletion followed by a single or multiple dose of CCT301-38 via intravenous injection.

Timeline

• Start date: 2021-12-30
• Primary completion: 2024-08-15
• Completion: 2024-10-24
• First posted: 2021-11-22
• Last updated: 2024-10-28

Locations

1 site across 1 country: China