CMV-CMI in csCMVi After HSCT

Study of CMV Specific Immune Reconstitution in Patients With Clinical Significant CMV Infection After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)

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.

Study Overview

• Status: Recruiting
• Conditions: Cytomegalovirus Infections; Hematopoietic Stem Cell Transplantation (HSCT); Immune Reconstitution
• Intervention / Treatment: Drug: Anti-Cytomegalovirus Therapy

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Feng Chen, MD; Phone Number: +8613584861215; Email: 13584861215@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: The First Affiliated Hospital of Soochow University; Phone Number: +86 512 67972861; Email: sdfyec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of CMV-seropositive adults (≥18 years of age) who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT) and experience their first CMV reactivation after transplantation.

Description

Inclusion Criteria:

1. ≥18 years old and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT);
2. First CMV reactivation after transplantation;
3. Life expectancy of ≥8 weeks;
4. The participant (or legally acceptable representative, if applicable) has provided written informed consent for the trial.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

CMV Reactivation Cohort; Adult CMV-seropositive patients (≥18 years) who experience first CMV reactivation after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Therapy with anti-CMV drugs (mono- or combination therapy, at investigator's discretion) is initiated upon diagnosis of CMV viremia and continued until two consecutive negative CMV DNA tests separated by ≥5 days. CMV-specific T cell levels are measured by ELISPOT at four time points: at CMV viremia diagnosis, 3 weeks after starting preemptive therapy, at anti-CMV drug withdrawal, and 4 weeks after treatment discontinuation. Patients are followed for 12 weeks after treatment cessation.

Drug: Anti-Cytomegalovirus Therapy; The choice of agent (monotherapy or combination) is at the investigator's discretion and may include ganciclovir, valganciclovir, foscarnet, maribavir, or other approved anti-CMV medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CMV-specific T cells	Number of IFN-γ-producing T cells per 250,000 PBMCs measured by ELISPOT	from baseline to 4 weeks after end of treatment, an average of 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of refractory CMV infection	From Day 1 (first anti-CMV dose) through EOT (inclusive), an average of 4 weeks
Cumulative incidence of CMV disease	From EOT+1 day through 12 weeks after EOT(end of follow-up)
Cumulative incidence of recurrent CMV infection	From EOT+1 day through 12 weeks after EOT (end of follow-up)
Cumulative incidence of acute graft-versus-host disease (aGVHD)	From Day 1 through 12 weeks after EOT (end of follow-up)
Overall survival	From Day 1 through 12 weeks after EOT (end of follow-up).

Other Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of non-relapse mortality (NRM)	From Day 1 through 12 weeks after EOT (end of follow-up).

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cytomegalovirus; Hematopoietic Stem Cell Transplantation; cell-mediated immunity; Virus-specific T cells
• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: CMV-CMI in csCMVi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) for the primary and secondary outcome measures will be made available upon reasonable request to the principal investigator. Data will be shared after publication of the primary study results, for research purposes only, under a data transfer agreement that ensures compliance with ethical and confidentiality requirements. Supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available as supplementary files.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No