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NCT01744223 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant
A Phase 1 study of Lymphoma and Myelodysplastic Syndromes, sponsored by Bellicum Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 8
- Study locations
NCT01744223: Active Phase 1 study of Lymphoma and Myelodysplastic Syndromes, sponsored by Bellicum Pharmaceuticals.
NCT01744223 is a Phase 1 study of Lymphoma and Myelodysplastic Syndromes that is active but no longer recruiting, run by Bellicum Pharmaceuticals. The registered enrollment target is 36 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01744223, a Phase 1 study of Lymphoma and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Bellicum Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the laboratory and then given back to the patient along with the stem cell transplant (T cell addback), can help the immune system recover faster after the transplant. As a safety measure, these T cells have been "programmed" with a "self-destruct switch" so that if, after they have been given to the patient, the T cells start to react against the tissues (called "graft versus host" disease, GVHD), the T cells can be destroyed.
Primary Outcome
To evaluate the safety of infusion of each of 4 dose cohorts of BPX-501 (2x105, 5x105, 1x106 and 3x106 cells/kg) after transplantation of partially mismatched T cell depleted hematopoietic stem cell transplant (HSCT)
Conditions Studied
Interventions
- DRUG Rimiducid
- BIOLOGICAL BPX-501 dose 1
- BIOLOGICAL BPX-501 dose 2
- BIOLOGICAL BPX-501 dose 3
- BIOLOGICAL BPX-501 dose 4
Study Locations (8)
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
Texas
- Baylor Sammons Cancer Center - Dallas
- UT Southwestern Medical Center - Dallas
Georgia
- Emory University Winship Cancer Institute - Atlanta
Ohio
- University Hospitals of Cleveland - Cleveland
Oregon
- Oregon Health & Science University - Portland
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2013-03 |
| Est. Completion | 2032-10 |
| Phase | Phase 1 |
What the registry record for NCT01744223 still lists
NCT01744223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Rimiducid is the first listed.
NCT01744223 lists 8 locations in 6 states (New York, Texas, Georgia).
Frequently Asked Questions
What is clinical trial NCT01744223 about?
NCT01744223 is a clinical study titled "Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant". This study will evaluate patients with blood cell cancers who are going to have an allogeneic (donor) blood stem cell transplant from a partially matched relative. The research study will test whether immune cells, called T cells, which come from the donor relative and are specially grown in the lab...
What is the current status of trial NCT01744223?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2013-03. Estimated completion is 2032-10.
What conditions does trial NCT01744223 study?
This clinical trial studies the following conditions: Lymphoma, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia.
What interventions are being tested in trial NCT01744223?
The interventions under investigation include: Rimiducid (DRUG), BPX-501 dose 1 (BIOLOGICAL), BPX-501 dose 2 (BIOLOGICAL), BPX-501 dose 3 (BIOLOGICAL), BPX-501 dose 4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01744223?
This trial is sponsored by Bellicum Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01744223 being conducted?
This trial has 8 study locations across Georgia, New York, Ohio, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01744223's enrollment target sits among peer trials
36 193rd of 299 higher than 105 of 299 other Lymphoma trials
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