Safety Study of Gene Modified Donor T-cells Following TCR Alpha Beta Depleted Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Cytopenia
- Acute Lymphoblastic Leukemia
- Anemia, Aplastic
- Anemia, Sickle Cell
- Diamond Blackfan Anemia
- ? Thalassemia
- Fanconi Anemia
- Primary Immunodeficiency
- Hemoglobinopathies
- Leukemia, Acute Myeloid (AML), Child
- Lymphoma Non-Hodgkin
- Myelodysplastic Syndrome
- Osteopetrosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 118 years
- Gender
- Both males and females
Description
This is a Phase II extension study evaluating the safety and feasibility of BPX-501 T cells infused after partially mismatched, related, TCR alpha beta T cell depleted hematopoietic stem cell transplant (HSCT) in pediatric patients. The purpose of this clinical trial is to determine whether BPX-501 ...
This is a Phase II extension study evaluating the safety and feasibility of BPX-501 T cells infused after partially mismatched, related, TCR alpha beta T cell depleted hematopoietic stem cell transplant (HSCT) in pediatric patients. The purpose of this clinical trial is to determine whether BPX-501 infusion can enhance immune reconstitution in those patients with hematologic disorders, with the potential for reducing the severity and duration severe acute graft versus host disease (GvHD). The trial will also evaluate the treatment of GvHD by the infusion of dimerizer drug (AP1903/rimiducid) in those subjects who present with GVHD who progress or do not respond to standard of care treatment.
Tracking Information
- NCT #
- NCT02065869
- Collaborators
- Not Provided
- Investigators
- Study Director: Bellicum Pharmaceuticals Bellicum Pharmaceuticals, Inc.
Get Well Soon