Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT

Last updated: October 4, 2023
Sponsor: Peking University People's Hospital
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Cytomegalovirus Infections

Stem Cell Transplant

Treatment

Virus specific T cells

Clinical Study ID

NCT06075927
2023PHD006-001
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 celltransplantation.
  • 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 whenenrolled.
  • 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

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 monoclonalantibody immunosuppressants, or participated in any other clinical research related todrugs and medical devices within 28 days before enrollment.
  • Poor compliance, and subjects deemed unsuitable for study participation by theinvestigator.

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: Virus specific T cells
Phase: 1/2
Study Start date:
November 01, 2023
Estimated Completion Date:
October 30, 2025

Study Description

This study consists of two parts: (1) The first stage is the safety evaluation of multi-virus VSTs and the exploration of DLT and MTD; (2) The second phase is to evaluate the safety and efficacy of multi-viral VSTs in selecting appropriate doses in the first phase.