Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

October 9, 2019

Study Completion Date

October 31, 2032

Conditions
Acute Lymphoblastic LeukemiaAcute Myelogenous LeukemiaLymphomaMyelodysplastic Syndromes
Interventions
BIOLOGICAL

BPX-501 dose 1

Subjects will receive 2x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

DRUG

Rimiducid

Dimerizer drug administered by intravenous infusion in those subjects who develop GVHD after infusion of BPX-501 cells.

BIOLOGICAL

BPX-501 dose 2

Subjects will receive 5x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BIOLOGICAL

BPX-501 dose 3

Subjects will receive 1x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

BIOLOGICAL

BPX-501 dose 4

Subjects will receive 3x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.

PROCEDURE

SCT

all subjects will receive an alpha beta depleted donor transplant as part of treatment

Trial Locations (8)

10065

Memorial Sloan Kettering Cancer Center, New York

14263

Roswell Park Cancer Institute, Buffalo

30322

Emory University Winship Cancer Institute, Atlanta

44106

University Hospitals of Cleveland, Cleveland

75246

Baylor Sammons Cancer Center, Dallas

75390

UT Southwestern Medical Center, Dallas

97239

Oregon Health & Science University, Portland

98109

Fred Hutchinson Cancer Research Center, Seattle

Sponsors
All Listed Sponsors
lead

Bellicum Pharmaceuticals

INDUSTRY

NCT01744223 - Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant | Biotech Hunter | Biotech Hunter