drugset
drugset / Trial / NCT03459170

Safety/PK Study of Gene Modified Donor T Cell Infusion in Children With Recurrent Hem Malignancies After Allo Transplant

NCT03459170 ↗

Phase 1 Active not recruiting 15 enrolled Bellicum Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

Phase I, open-label, non-randomized study of safety, pharmacokinetics and efficacy of donor BPX-501 T cell infusion in children with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The study will consist of the Main Study and an optional Pharmacokinetics (PK) Sub-Study.

Timeline

Start
2018-02-01
Primary completion
2022-09
Completion
2035-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Rimiducid Other / unclassified 0.04 mg/kg —
Subject Rimiducid Other / unclassified 0.1 mg/kg —
Subject Rimiducid Other / unclassified 0.4 mg/kg —
Subject rivogenlecleucel Cell therapy — —

Indications

hematopoietic and lymphoid cell neoplasm