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NCT03301168 · ClinicalTrials.gov record · last posted 2022-07-12

Study of Gene Modified Donor T-cells Following TCR Alpha Beta Positive Depleted Stem Cell Transplant

StatusActive, Not Recruiting
PhasePhase 1/2
Started2014-04
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from the ClinicalTrials.gov record
This study will evaluate pediatric patients with malignant or non-malignant blood cell disorders who are having a blood stem cell transplant depleted of T cell receptor (TCR) alfa and beta cells that comes from a partially matched family donor. The study will assess whether immune cells, called T cells, from the family donor, that are specially grown in the laboratory and given back to the patient along with the stem cell transplant can help the immune system recover faster after transplant. As a safety measure these T cells have been programmed with a self-destruct switch so that they can be destroyed if they start to react against tissues (graft versus host disease).

Amendment record 17 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 17 times since 2017-10-03; 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 ↗

2019-01-18
Status change Recruiting→Active, Not Recruitingv11
Trial Details
NCT Number NCT03301168
Lead Sponsor Bellicum Pharmaceuticals
Conditions Acute Lymphoblastic Leukemia, Leukemia, Acute Myeloid (AML), Child, Lymphoma, Non-Hodgkin, Myelodysplastic Syndromes, Primary Immune Deficiency Disorder, Osteopetrosis, Cytopenia, Hemoglobinopathy in Children +1 more
Enrollment 120 participants
Start Date 2014-04
Primary Completion 2021-05-11 (estimated)
Study Completion 2034-05 (estimated)
Updated on ClinicalTrials.gov 2022-07-12