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PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv21
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v20
  3. Primary completion date: Jan 1, 2023 to Aug 1, 2024v19 Show 8 more changesShow less
    • Primary endpoints revised (2)
    • Study completion date: Jan 1, 2024 to Aug 1, 2025
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description expanded, about 6 words
    • Site contacts updated at 1 of 2 sites
    • Publications expanded, about 130 words
    • Study title expanded, about 4 words
  4. Lead sponsor: PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc. to Precigen, Incv18
  5. Study sites: 1 to 2v17
Show 15 earlier versionsHide 15 earlier versions
  1. Enrollment target: 56 to 88v16 Show 6 more changesShow less
    • Primary completion date: May 1, 2022 to Jan 1, 2023
    • Study completion date: May 1, 2025 to Jan 1, 2024
    • Site contact updated
    • Study title revised
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word
  2. Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute to PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.v15 Show 5 more changesShow less
    • Site contact updated
    • Eligibility criteria expanded, about 3 words
    • Study description shortened, about 5 words
    • Collaborators shortened, about 2 words
    • Study title expanded, about 1 word
  3. 2 versions Re-verified since Dec 3, 2020, no change to tracked fieldsv13-v14
  4. Eligibility criteria shortened, about 10 wordsv12
  5. Site contact updatedv11
  6. Re-verified, no change to tracked fieldsv10
  7. Start date: May 17, 2019 to May 20, 2019v9
  8. Site contact updatedv8
  9. Re-verified, no change to tracked fieldsv7
  10. Start date: May 7, 2019 to May 17, 2019v6
  11. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2019 to May 7, 2019
    • Site details revised
    v5
  12. Eligibility criteria shortened, about 1 wordv4
  13. Study title shortened, about 1 wordv3
  14. Re-verified, no change to tracked fieldsv2
  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 is a first-in-human dose escalation/dose expansion study to evaluate the safety and identify the best dose of modified immune cells, PRGN-3006 (autologous chimeric antigen receptor (CAR) T cells), in adult patients with relapsed or refractory acute myeloid leukemia (AML), Minimal Residual Disease (MRD) positive acute myeloid leukemia or higher risk myelodysplastic syndrome (MDS). Autologous CAR T cells are modified immune cells that have been engineered in the laboratory to specifically target a protein found on tumor cells and kill them.
Trial Details
NCT Number NCT03927261
Lead Sponsor Precigen, Inc
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Myelodysplastic Syndromes
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 88 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov