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NCT03459170 · ClinicalTrials.gov record · last posted 2022-07-12

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

StatusActive, Not Recruiting
PhasePhase 1
Started2018-02-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 12, 2022 (before its estimated September 2022 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.

Amendment record 7 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 7 times since 2018-03-02; most recent amendment 2022-07-10. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2020-10-01
Status change Recruiting→Active, Not Recruitingv6
Trial Details
NCT Number NCT03459170
Lead Sponsor Bellicum Pharmaceuticals
Conditions Hematologic Malignancy
Enrollment 15 participants
Start Date 2018-02-01
Primary Completion 2022-09 (estimated)
Study Completion 2035-09 (estimated)
Updated on ClinicalTrials.gov 2022-07-12