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Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

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

Record History

The 50 most recent of 71 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv71
  2. Interventions: PRGN-2012 (Drug) to PRGN-2012 - Phase I; Dose Level 1 (Drug), PRGN-2012 - Phase I; Dose Level 2 (Drug), PRGN-2012 - Phase II; Dose Level 2 (Drug)
    • Study arms: 2 to 3
    v70
  3. Publications: details revised at 1 of 1 entry
    • Study arms: 1 to 2
    v69
  4. Primary completion date changed from estimate of Jun 2, 2024 to Jun 5, 2024
    • Study completion date: Jun 2, 2026 to Jun 5, 2026
    v68
  5. Primary endpoints revised (2)v67 Show 8 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 48 to confirmed 38
    • Primary completion date: Mar 20, 2024 to Jun 2, 2024
    • Study completion date: Mar 20, 2024 to Jun 2, 2026
    • Secondary endpoints: 4 to 10
    • Study description shortened, about 7 words
    • Site details revised
    • Eligibility criteria expanded, about 3 words
Show 45 earlier versionsHide 45 earlier versions
  1. Lead sponsor: PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc. to Precigen, Inc
    • Primary completion date: Oct 20, 2022 to Mar 20, 2024
    • Study completion date: Oct 20, 2023 to Mar 20, 2024
    v66
  2. Lead sponsor: National Cancer Institute (NCI) to PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.v65 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria shortened, about 76 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description shortened, about 261 words
    • Study arms: 2 to 1
    • Collaborators expanded, about 4 words
  3. 17 versions Re-verified since Feb 25, 2022, no change to tracked fieldsv48-v64
  4. Phase: Phase 1 to Phase 1/2v47 Show 5 more changesShow less
    • Enrollment target: 22 to 48
    • Primary endpoints: 1 to 2
    • Secondary endpoints: 2 to 4
    • Study description expanded, about 74 words
    • Study arms: 1 to 2
  5. 2 versions Re-verified since Sep 2, 2021, no change to tracked fieldsv45-v46
  6. Eligibility criteria shortened, about 18 wordsv44
  7. Start date changed from estimate of Mar 29, 2021 to Mar 16, 2021v43
  8. Start date: Mar 26, 2021 to Mar 29, 2021v42
  9. Start date: Mar 25, 2021 to Mar 26, 2021v41
  10. Start date: Mar 24, 2021 to Mar 25, 2021v40
  11. Start date: Mar 23, 2021 to Mar 24, 2021v39
  12. Start date: Mar 22, 2021 to Mar 23, 2021v38
  13. Start date: Mar 19, 2021 to Mar 22, 2021v37
  14. Start date: Mar 18, 2021 to Mar 19, 2021v36
  15. Start date: Mar 17, 2021 to Mar 18, 2021v35
  16. Start date: Mar 16, 2021 to Mar 17, 2021v34
  17. Start date: Mar 15, 2021 to Mar 16, 2021v33
  18. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 12, 2021 to Mar 15, 2021
    • Site details revised
    v32
  19. Start date: Mar 11, 2021 to Mar 12, 2021v31
  20. Start date: Mar 10, 2021 to Mar 11, 2021v30
  21. Start date: Mar 9, 2021 to Mar 10, 2021v29
  22. Start date: Mar 8, 2021 to Mar 9, 2021v28
  23. Start date: Mar 5, 2021 to Mar 8, 2021v27
  24. Start date: Mar 4, 2021 to Mar 5, 2021v26
  25. Start date: Mar 3, 2021 to Mar 4, 2021v25
  26. Start date: Mar 2, 2021 to Mar 3, 2021v24
  27. Start date: Mar 1, 2021 to Mar 2, 2021v23
  28. Study Statusv22
  • 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 Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.
Trial Details
NCT Number NCT04724980
Lead Sponsor Precigen, Inc
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Recurrent Respiratory Papillomatosis, Papillomavirus Infections, Papillomaviridae
Related terms Papillomavirus Infections, Recurrent respiratory papillomatosis
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov