CMV-CMI in csCMVi After HSCT

Recruiting now

Conditions studied: Cytomegalovirus Infections, Hematopoietic Stem Cell Transplantation (HSCT), Immune Reconstitution

In brief

Cytomegalovirus (CMV) reactivation is a common and serious complication after allogeneic hematopoietic stem cell transplantation (allo-HSCT), and the reconstitution of CMV-specific cell-mediated immunity (CMV-CMI) plays a key role in viral control. This prospective, exploratory study will enroll 40 adult CMV-seropositive patients who experience their first CMV reactivation after allo-HSCT. CMV-specific T cell levels (IFN-γ-producing T cells stimulated by IE-1 and pp65 antigens) will be measured using ELISPOT at four time points: at diagnosis of CMV viremia, 3 weeks after initiating preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients will be followed for 12 weeks after stopping treatment. The primary objective is to describe the changes in CMV-specific T cell levels over the therapy. Secondary objectives are to explore the relationship between these levels and the occurrence of refractory CMV infection, recurrent CMV infection, and CMV disease. Findings may help identify patients at high risk of progressing to severe or persistent CMV infection at an early stage of preemptive therapy, enabling personalized intervention strategies.

Key facts

Study ID

NCT07688759

Run by

The First Affiliated Hospital of Soochow University

People needed

40

Starts

2026-06-01

Expected to finish

2028-08-31

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
• First CMV reactivation after transplantation;
• Life expectancy of ≥8 weeks;
• The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.

You may not qualify if…

• Recurrence of CMV infection;
• primary CMV infection in CMV-seronegative recipients (R-);
• Resistance to known anti-CMV drugs (ganciclovir, valganciclovir, foscarnet, maribavir, etc.);
• Currently receiving CMV-CTL treatment or lymphocyte infusion.

Where it is running

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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