drugset / Trial / NCT04197596
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
Phase 1/2
Recruiting
40 enrolled
New York Medical College
Children's Hospital of Philadelphia · collabJohns Hopkins University · collabMedical College of Wisconsin · collabNationwide Children's Hospital · collabUniversity of California, San Francisco · collab
NaSingle-groupOpen-labelTreatment
Summary
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Timeline
- Start
- 2020-07-01
- Primary completion
- 2026-12-31
- Completion
- 2027-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BK CTL | Cell therapy | 5000 cells/kg | Intravenous |
| Subject | BK CTL | Cell therapy | 25000 cells/kg | Intravenous |