Treatment of CMV in a patient with profound combined immunodeficiency, who has viremia and pneumonia, using CMV-specific donor-derived T lymphocytes (CMV-VST).
Eligibility
Sex
FEMALE
Min age
0 Years
Max age
20 Years
Healthy volunteers
No
Inclusion Criteria:
* profound combined immunodeficiency
* cytomegalovirus (CMV) infection
* viremia
* pneumonia
Exclusion Criteria:
* Receiving a steroid dose of ≥ 0.5 mg/kg of prednisolone equivalent
* Receiving antithymocyte globulin or similar anti-T-cell antibody therapy, methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells, and extracorporeal
* Receiving checkpoint inhibitor agents (eg, nivolumab, pembrolizumab, ipilimumab) are within 3 drug half-lives of the most recent dose to cycle 1 day 1.
* Administration of another investigational product
Primary outcome measure(s)
Feasibility of study — Enrollment to 24 months Evaluate the feasibility of conducting this study, evaluated in terms of whether or not the study could be completed as laid out in the protocol in the time allotted.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — Weekly to 3 months AEs assessed according to CTCAE grading criteria.
Efficacy of Intervention — Weekly to 3 months Change in viremia from baseline according to PCR testing after the intervention
Efficacy of Intervention — Monthly from 3 to 12 months Change in viremia from baseline according to PCR testing after the intervention
Efficacy of Intervention — Every 3 months from 12-24 months Change in viremia from baseline according to PCR testing after the intervention
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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