drugset / Trial / NCT02849886
T Lymphocytes (LT) Expressing iCASP9 and ΔCD19 in Allogeneic Haematopoietic Transplantation.
Phase 1/2
Terminated
2 enrolled
Centre Hospitalier Universitaire de Besancon
Bellicum Pharmaceuticals · collabEtablissement Français du Sang · collab
Non-randomizedSingle-groupOpen-labelPrevention
Summary
This study evaluates the frequency of occurrence, severity, and response to treatment by a chemical agent, notably the dimerizer AP1903 (Bellicum Pharmaceuticals compagny), in the case of acute Graft versus Host Disease (aGvHD) occurring after the administration of T-lymphocytes expressing iCASP9 and concomitantly to a bone marrow graft depleted in B- and T-lymphocytes
Timeline
- Start
- 2019-04-10
- Primary completion
- 2021-12-26
- Completion
- 2021-12-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rimiducid | Other / unclassified | 0.4 mg/kg | Intravenous |
| Subject | T lymphocytes iCASP9 ΔCD19 | Cell therapy | 2.1 cells/kg | Intravenous |
| Subject | T lymphocytes iCASP9 ΔCD19 | Cell therapy | 5.1 cells/kg | Intravenous |
| Subject | T lymphocytes iCASP9 ΔCD19 | Cell therapy | 10.1 cells/kg | Intravenous |