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

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

Record History

  1. Primary completion date: Oct 2019 to Oct 9, 2019 Completion date: Nov 2032 to Oct 2032v27 Show 1 more changeShow less
    • Completion date: Nov 2032 to Oct 2032
  2. Primary completion date: Mar 26, 2018 to Oct 2019 Primary endpoints: 1 to 4 · Study sites: 5 to 8 · Completion date: Dec 2033 to Nov 2032 · 3 morev26 Show 6 more changesShow less
    • Primary endpoints: 1 to 4
    • Study sites: 5 to 8
    • Completion date: Dec 2033 to Nov 2032
    • Interventions: AP1903 (Drug), BPX-501 dose 1 (Biological), BPX-501 dose 2 (Biological), BPX-501 dose 3 (Biological), BPX-501 dose 4 (Biological), SCT… to BPX-501 dose 1 (Biological), BPX-501 dose 2 (Biological), BPX-501 dose 3 (Biological), BPX-501 dose 4 (Biological), Rimiducid (Drug), SCT…
    • Secondary endpoints: 3 to 9
    • Study description shortened, about 17 words

    See this version in full on ClinicalTrials.gov ↗

  3. Completion date: Dec 2020 to Dec 2033v25
  4. Re-verified, no change to tracked fieldsv24
  5. Interventions: BPX-501 (rivogenlecleucel) and AP1903 (rimiducid) (Biological) to AP1903 (Drug), BPX-501 dose 1 (Biological), BPX-501 dose 2 (Biological), BPX-501 dose 3 (Biological), BPX-501 dose 4 (Biological), SCT… Study arms: 1 to 4v23 Show 1 more changeShow less
    • Study arms: 1 to 4
Show 21 earlier versionsHide 21 earlier versions
  1. Primary completion date changed from estimate of Mar 2020 to Mar 26, 2018 Interventions: BPX-501 and AP1903 (Biological) to BPX-501 (rivogenlecleucel) and AP1903 (rimiducid) (Biological)v22 Show 1 more changeShow less
    • Interventions: BPX-501 and AP1903 (Biological) to BPX-501 (rivogenlecleucel) and AP1903 (rimiducid) (Biological)
  2. Re-verified, no change to tracked fieldsv21
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 6 to 5v20 Show 1 more changeShow less
    • Study sites: 6 to 5
  4. Re-verified, no change to tracked fieldsv19
  5. Eligibility criteria expanded, about 297 wordsv18 See this version in full on ClinicalTrials.gov ↗
  6. Primary completion date: Jun 2018 to Mar 2020 Completion date: Dec 2018 to Dec 2020v17 Show 1 more changeShow less
    • Completion date: Dec 2018 to Dec 2020
  7. Primary completion date: Feb 2018 to Jun 2018 Completion date: Mar 2018 to Dec 2018v16 Show 1 more changeShow less
    • Completion date: Mar 2018 to Dec 2018
  8. Primary completion date: Dec 2017 to Feb 2018v15
  9. Site details revised at 1 of 6 sitesv14
  10. Primary completion date: Jun 2017 to Dec 2017 Completion date: Dec 2018 to Mar 2018 · Secondary endpoints: 2 to 3v13 Show 2 more changesShow less
    • Completion date: Dec 2018 to Mar 2018
    • Secondary endpoints: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  11. Primary completion date: Jan 2017 to Jun 2017v12
  12. Study sites: 4 to 6v11
  13. Re-verified, no change to tracked fieldsv10
  14. Study sites: 5 to 4v9
  15. Study sites revised (5)v8 See this version in full on ClinicalTrials.gov ↗
  16. Primary completion date: Jan 2015 to Jan 2017 Completion date: Dec 2016 to Dec 2018 · Study sites revised (5)v7 Show 2 more changesShow less
    • Completion date: Dec 2016 to Dec 2018
    • Study sites revised (5)

    See this version in full on ClinicalTrials.gov ↗

  17. Primary completion date: Dec 2014 to Jan 2015 Study sites revised (5)v6 Show 1 more changeShow less
    • Study sites revised (5)

    See this version in full on ClinicalTrials.gov ↗

  18. Site details revised at 2 of 5 sitesv5
  19. Study sites: 2 to 5 Primary completion date: Jul 2014 to Dec 2014 · Completion date: Jul 2016 to Dec 2016v4 Show 2 more changesShow less
    • Primary completion date: Jul 2014 to Dec 2014
    • Completion date: Jul 2016 to Dec 2016
  20. Site details revised at 2 of 2 sitesv3
  21. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 2012 to Mar 2013 · Study description revised · Site details revised at 2 of 2 sitesv2 Show 3 more changesShow less
    • Start date: Dec 2012 to Mar 2013
    • Study description revised
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  1. 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.
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.
Trial Details
NCT Number NCT01744223
Lead Sponsor Bellicum Pharmaceuticals
Conditions Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma, Myelodysplastic Syndromes
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov