NCT04153279

CMV-TCR-T Cells for CM Virus Infection After HSCT

A Pilot Study of CMV-TCR-T Cells in CM Virus Infection Diseases After HSCT

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Hebei Yanda Ludaopei Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single cente, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after HSCT.

Detailed description

CMV infection is a common virus infection of HSCT, and which is highly related with the failure of transplantation and survival time of transplant patients. To evaluate the safety and efficacy of allogenic CMV-TCR-T cell therapy in subjects with CMV infection, patients with CMV emias or deseases will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).

Conditions

• CMV Infection or Reactivation After Allogenic HSCT

Interventions

Type	Name	Description
BIOLOGICAL	CMV-TCR-T cells	Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A\*1101\\0201\\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).

Timeline

• Start date: 2019-12-19
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2019-11-06
• Last updated: 2023-01-12

Locations

1 site across 1 country: China