Clinical trial · Interventional
Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT
An Exploratory Clinical Study of Multivirus-specific T Cells in the Treatment of Refractory Cytomegalovirus and/or Epstein-Barr Virus Infection After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV). Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CMV Infection | — | UNRESOLVED | — |
| EBV Infection | — | UNRESOLVED | — |
| Stem Cell Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Virus specific T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VSTs infusion
- description
- Phase I (dose escalation) : An open, single-arm, dose-escalation clinical study to explore the safety, tolerability, and cytodynamic characteristics of CMV and EBV-specific T cells (VSTs), with initial efficacy observations. Subjects enrolled with refractory CMV and/or EBV infection after allogeneic hematopoietic stem cell transplantation were subjected to a 3+3 dose-climb test. Exploring the safety, dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of intravenous infusion of multi-virus VSTs. (2) Phase II (dose expansion) : According to the clinically recommended or safe and effective dose determined by the phase I climb test, the extended study of 1-2 dose groups with 20 cases per dose was performed after joint review by the investigators and project collaborators.
- interventionNames
- Biological: Virus specific T cells
Primary outcomes (2)
- measure
- Assessment of safety and toxicity outcomes in subjects receiving VSTs infusion
- timeFrame
- within 56 days after the first VSTs infusion
- description
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, and graft-versus-host-disease will be summarized using descriptive statistics for each dose level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old, and less than or equal to 70 years old, gender is not limited. * Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation. * Persistent infection with CMV and/or EBV persists despite standard treatment . * Prednisone or its equivalent hormone is less than or equal to 0.5 mg/kg/ day when enrolled. * ECOG score ≤3, expected survival greater than 3 months. * End blood oxygen saturation ≥90% on room air. * Available multi-virus-specific cytotoxic T lymphocytes. * Negative pregnancy test in female patients if applicable. * Written informed consent and/or signed assent line from patient, parent or guardian. Exclusion Criteria: * Within 28 days after allogeneic hematopoietic stem cell transplantation. * Active III-IV acute GVHD, and/or moderate and above chronic GVHD. * Severe organ dysfunction: Heart: New York Heart Association (NYHA) levels III and IV; Liver: Total bilirubin\>34umol/l; ALT, AST\>2 times the normal upper limit; Kidney: Blood creatinine \>130umol/L; Lung: Type I or II respiratory failure; Brain: unconsciousness, intracranial hypertension. * Received DLI, other CTL, CAR-T, NK and other cell therapies, T cell monoclonal antibody immunosuppressants, or participated in any other clinical research related to drugs and medical devices within 28 days before enrollment. * Poor compliance, and subjects deemed unsuitable for study participation by the investigator.
References
Publications (0)
Data not yet available