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Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion

Study acronym: HAPLOTAB
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from May 23, 2026 to May 23, 2027 Eligibility criteria expanded, about 24 words · Secondary endpoints: details revised at 1 of 3 entries · Site details revised at 1 of 2 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 1 of 2 sites
  2. Results first posted: Oct 30, 2025v12
  3. Trial status: Terminated to Active, Not Recruiting Completion date: Aug 29, 2024 to May 23, 2026v11 Show 1 more changeShow less
    • Completion date: Aug 29, 2024 to May 23, 2026
  4. Secondary endpoints revised (3) Primary endpoints revised (2)v10 Show 1 more changeShow less
    • Primary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints: 3 to 2 Secondary endpoints revised (3)v9 Show 1 more changeShow less
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Terminated Sponsor's reason: Closed to accrual as the investigators decided the current approach is not feasible. In the first 3 patients it was not feasible to… Enrollment target: estimated 47 to confirmed 3 · Primary completion date changed from estimate of Oct 2026 to Aug 29, 2024 · Study completion date changed from estimate of Aug 1, 2030 to Aug 29, 2024 · 1 morev8 Show 4 more changesShow less
    • Enrollment target: estimated 47 to confirmed 3
    • Primary completion date changed from estimate of Oct 2026 to Aug 29, 2024
    • Study completion date changed from estimate of Aug 1, 2030 to Aug 29, 2024
    • Site details revised at 2 of 2 sites
  2. Secondary endpoints: 2 to 3v7 See this version in full on ClinicalTrials.gov ↗
  3. Start date changed from estimate of Dec 2023 to Dec 6, 2023v6
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 2023 to Dec 2023 · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Start date: Oct 2023 to Dec 2023
    • Site details revised at 2 of 2 sites
  5. Primary completion date: Nov 10, 2025 to Oct 2026 Start date: Jul 7, 2023 to Oct 2023v4 Show 1 more changeShow less
    • Start date: Jul 7, 2023 to Oct 2023
  6. Start date: Mar 7, 2023 to Jul 7, 2023v3
  7. Primary completion date: Mar 10, 2025 to Nov 10, 2025 Start date: Apr 1, 2022 to Mar 7, 2023 · Completion date: Dec 1, 2029 to Aug 1, 2030 · Eligibility criteria expanded, about 2 words · 2 morev2 Show 5 more changesShow less
    • Start date: Apr 1, 2022 to Mar 7, 2023
    • Completion date: Dec 1, 2029 to Aug 1, 2030
    • Eligibility criteria expanded, about 2 words
    • Study description shortened, about 1 word
    • Study title shortened, about 5 words

    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.
Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. This process is expected to substantially decrease the risk of GvHD thus allowing for the elimination of immunosuppressive therapy post-transplant. The study will use blood stem/progenitor cells collected from the peripheral blood of parent or other half-matched (haploidentical) family member donor. The procedure will be performed using CliniMACS® TCRα/β-Biotin System which is considered investigational.
Trial Details
NCT Number NCT05236764
Lead Sponsor Baylor College of Medicine
Collaborators: Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
Conditions Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Hemophagocytic Lymphohistiocytoses, Primary Immunodeficiency Diseases, Hemoglobinopathies, Severe Aplastic Anemia +3 more
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov