drugset / Trial / NCT03266627
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
Phase 2
Recruiting
20 enrolled
New York Medical College
Children's Hospital of Philadelphia · collabIndiana University · collabJohns Hopkins University · collabMedical College of Wisconsin · collabNationwide Children's Hospital · collabUniversity of California, Los Angeles · collabUniversity of California, San Francisco · collabUniversity of Colorado, Denver · collabWashington University School of Medicine · collab
NaSingle-groupOpen-labelTreatment
Summary
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
Timeline
- Start
- 2018-11-01
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytotoxic T Lymphocytes | Cell therapy | 5000 cells/kg | Intravenous |
| Subject | Cytotoxic T Lymphocytes | Cell therapy | 25000 cells/kg | Intravenous |