Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03301168 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of May 2021 to May 11, 2021 Study sites revised (10)v18 Show 1 more changeShow less
  2. Notable Primary completion date: Feb 2020 to May 2021 Primary endpoints: 1 to 2 · Completion date: Feb 2035 to May 2034 · Interventions: AP1903 (Drug), BPX-501 T cells (Biological) to BPX-501 T cells (Biological), Rimiducid (Drug) · 3 morev17 Show 6 more changesShow less
    • Primary endpoints: 1 to 2
    • Completion date: Feb 2035 to May 2034
    • Interventions: AP1903 (Drug), BPX-501 T cells (Biological) to BPX-501 T cells (Biological), Rimiducid (Drug)
    • Secondary endpoints: 5 to 7
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Completion date: Feb 2021 to Feb 2035v16
  4. Minor Re-verified, no change to tracked fieldsv15
  5. Notable Primary completion date: Jun 2019 to Feb 2020 Completion date: Dec 2020 to Feb 2021v14 Show 1 more changeShow less
    • Completion date: Dec 2020 to Feb 2021
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv13
  2. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 10 of 10 sitesv12 Show 1 more changeShow less
    • Site details revised at 10 of 10 sites
  3. Minor Primary completion date: Dec 2018 to Jun 2019v11
  4. Minor Site details revised at 1 of 10 sitesv10
  5. Minor Re-verified, no change to tracked fieldsv9
  6. Minor Interventions: AP1903 (Drug), BPX-501 T cells and AP1903 (Biological) to AP1903 (Drug), BPX-501 T cells (Biological)v8
  7. Notable Primary endpoint revised Completion date: Dec 2019 to Dec 2020 · Secondary endpoints expanded, about 12 words · Site contacts updated at 2 of 10 sites · 3 morev7 Show 6 more changesShow less
    • Completion date: Dec 2019 to Dec 2020
    • Secondary endpoints expanded, about 12 words
    • Site contacts updated at 2 of 10 sites
    • Eligibility criteria shortened, about 5 words
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Minor Re-verified, no change to tracked fieldsv6
  9. Minor Site contacts updated at 1 of 10 sitesv5
  10. Minor Site contacts updated at 1 of 10 sitesv4
  11. Notable Primary endpoint revisedv3 See this version in full on ClinicalTrials.gov ↗
  12. Notable Enrollment target: 175 to 120 Study sites: 1 to 10v2 Show 1 more changeShow less
    • Study sites: 1 to 10
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2,566 trials monitored
See 143 trials at risk
and 2 more diseases
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).
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov