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

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option for patients who have persistent infections from two viruses, Cytomegalovirus (CMV) and Epstein-Barr virus (EBV), after receiving a stem cell transplant. The researchers want to see if using special immune cells, called virus-specific T cells, that are partially matched to the patient’s immune system can help fight these infections. The safety and tolerability of this treatment will be evaluated, along with how long these immune cells last after being given to the patients.

To be eligible for this trial, participants need to be between 18 and 70 years old and have had a stem cell transplant but continue to struggle with CMV or EBV infections despite standard treatments. Other requirements include having stable health without severe organ issues and being able to provide informed consent. The trial is not yet recruiting participants, but those who join can expect to receive close monitoring and care during the study. It's essential to discuss this option with a healthcare provider to see if it might be a suitable choice for managing their condition.

Gender

ALL

Eligibility criteria

• 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.