A Phase 1 interventional study of CMV-TCR-T cells in CMV Infection After Allogenic HSCT, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 12 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
The patients with CMV infection after HSCT will receive one to three infusions of donor-derived CMV-TCR-T cells, with the escalated dose ranging from 1×10\^3/kg to 5×10\^5/kg CMV-TCR-T cells per dose.
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.
Adverse events
Percentage of participants with adverse events.
Time frame: 1 year
Changes of CMV-DNA copies number
Quantitative PCR will be used to determine viral copy numbers in peripheral blood.
Time frame: 1 year
Persistence of CMV-TCR-T cells
Quantitative PCR using primers specific for the gene encoding CMV-TCR will be used to determine the number of circulating CMV-TCR-T cells in peripheral blood post infusion.
Time frame: 1 year
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital