NCT05140187

CMV-TCR-T Cells for CMV Infection After Allogenic HSCT

Adoptive Immunotherapy With Donor-derived CMV-TCR-T Cells for Patients With CMV Infection After Allogenic HSCT

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restricted CMV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate CMV-TCR-T cells. An escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg of CMV-TCR-T cells will be infused into patients with CMV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic CMV-TCR-T cell therapy will be evaluated.

Conditions

• CMV Infection After Allogenic HSCT

Interventions

Type	Name	Description
BIOLOGICAL	CMV-TCR-T cells	The patients with CMV infection after HSCT will receive one to three doses of donor-derived CMV-TCR-T cells, with the escalated doses including 1×10\^3/kg, 1×10\^5/kg, and 5×10\^5/kg CMV-TCR-T cells per dose.

Timeline

• Start date: 2021-10-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-12-01
• Last updated: 2023-03-29

Locations

1 site across 1 country: China