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Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

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

Record History

  1. Primary completion date: Jan 2020 to Jan 14, 2020v20
  2. Primary completion date: Mar 26, 2018 to Jan 2020 Primary endpoints: 2 to 5 · Study sites: 7 to 5 · Completion date: Dec 2034 to Jan 2033 · 2 morev19 Show 5 more changesShow less
    • Primary endpoints: 2 to 5
    • Study sites: 7 to 5
    • Completion date: Dec 2034 to Jan 2033
    • Interventions: AP1903 (Drug), BPX-501 (Biological) to BPX-501 (Biological), Rimiducid (Drug)
    • Secondary endpoints: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2019 to Mar 26, 2018v18
  4. Completion date: Dec 2020 to Dec 2034v17
  5. Re-verified, no change to tracked fieldsv16
Show 14 earlier versionsHide 14 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 24 to confirmed 10 · Study sites: 8 to 7v15 Show 2 more changesShow less
    • Enrollment target: estimated 24 to confirmed 10
    • Study sites: 8 to 7
  2. Re-verified, no change to tracked fieldsv14
  3. Site contacts updated at 1 of 8 sitesv13
  4. Primary endpoints: 1 to 2 Secondary endpoint revised · Study description shortened, about 90 words · Eligibility criteria shortened, about 5 wordsv12 Show 3 more changesShow less
    • Secondary endpoint revised
    • Study description shortened, about 90 words
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 2 of 8 sitesv11
  6. Site details revised at 1 of 8 sitesv10
  7. Re-verified, no change to tracked fieldsv9
  8. Study sites: 7 to 8v8
  9. Re-verified, no change to tracked fieldsv7
  10. Site details revised at 1 of 7 sitesv6
  11. Site details revised at 1 of 7 sitesv5
  12. Study sites: 4 to 7 Eligibility criteria shortened, about 73 words · Study description shortened, about 2 wordsv4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 73 words
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  13. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2018 to Dec 2019 · Completion date: Dec 2030 to Dec 2020 · Study sites revised (4)v3 Show 3 more changesShow less
    • Primary completion date: Dec 2018 to Dec 2019
    • Completion date: Dec 2030 to Dec 2020
    • Study sites revised (4)

    See this version in full on ClinicalTrials.gov ↗

  14. Start date: Jul 2015 to Jul 2016v2
  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.
A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of increasing doses of BPX-501 T cell infusions to achieve a clinical response. Rimiducid will be investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose that can mitigate GvHD and preserve the graft versus leukemia effect.
Trial Details
NCT Number NCT02477878
Lead Sponsor Bellicum Pharmaceuticals
Conditions Leukemia, Myelodysplastic Syndromes, Lymphoma, Multiple Myeloma, Hematologic Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov