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ACTIVE NOT RECRUITING
NCT03459170
PHASE1

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

Sponsor: Bellicum Pharmaceuticals

View on ClinicalTrials.gov

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.

Official title: A Phase I Study Of Safety, Pharmacokinetics, And Efficacy Of Donor BPX-501 Cells and Rimiducid Infusion For Children With Recurrent Hematologic Malignancies or Minimal Residual Disease After Allogeneic Transplant

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2018-02-01

Completion Date

2035-09

Last Updated

2022-07-12

Healthy Volunteers

No

Interventions

BIOLOGICAL

BPX-501 T cells

Biological: T cells transduced with CaspaCIDe® safety switch

DRUG

rimiducid

administered to eliminate BPX-501 cells in the event of GVHD

Locations (3)

San Matteo Hospital

Pavia, Italy

IRCCS Ospedale Pediatrico Bambino Gesù

Rome, Italy

Ospedale Infantile Regina Margherita

Turin, Italy