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Modified Immune Cells (Autologous CAR T Cells) in Treating Patients with Advanced, Recurrent Platinum Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 8, 2024 (before its estimated December 15, 2024 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study Identification, Study Status, Conditionsv22
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v21
  3. Primary completion date: Dec 15, 2023 to Dec 15, 2024
    • Study sites: 1 to 2
    v20
  4. Lead sponsor: PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc. to Precigen, Incv19
  5. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 1 to 2
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Lead sponsor: Fred Hutchinson Cancer Center to PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.v17 Show 5 more changesShow less
    • Primary completion date: Apr 1, 2022 to Dec 15, 2023
    • Study completion date: Apr 1, 2026 to Nov 15, 2028
    • Interventions: PRGN-3005 UltraCAR-T cells (Biological) to PRGN-3005 UltraCAR-T cells (Biological), PRGN-3005 UltraCAR-T cells (Biological)
    • Collaborators shortened, about 6 words
    • Study arms: 1 to 2
  2. Re-verified, no change to tracked fieldsv16
  3. Eligibility criteria shortened, about 2 wordsv15
  4. Re-verified, no change to tracked fieldsv14
  5. Trial status: Suspended to Recruiting
    • Site details revised
    v13
  6. Trial status: Recruiting to Suspended Sponsor's reason: COVID19 Suspension
    • Site details revised
    v12
  7. Enrollment target: 41 to 71
    • Eligibility criteria expanded, about 7 words
    v11
  8. Trial status: Suspended to Recruiting
    • Site details revised
    v10
  9. Trial status: Recruiting to Suspended Sponsor's reason: Reviewing study data
    • Site details revised
    v9
  10. Trial status: Suspended to Recruiting
    • Site details revised
    v8
  11. Trial status: Recruiting to Suspended Sponsor's reason: Reviewing study data
    • Site details revised
    v7
  12. Site contact updatedv6
  13. Site contact updatedv5
  14. Site contact updatedv4
  15. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 24, 2019 to Apr 30, 2019
    • Site details revised
    v3
  16. Start date: Apr 12, 2019 to May 24, 2019v2
  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 Phase I/Ib dose escalation, dose expansion, study to evaluate the safety and identify the recommended dose of modified immune cells PRGN-3005 (autologous chimeric antigen receptor (CAR) T cells developed by Precigen, Inc.) in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body, that has come back and is resistant to platinum chemotherapy. 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 NCT03907527
Lead Sponsor Precigen, Inc
Conditions
(from sponsor)		 Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Refractory Fallopian Tube Carcinoma, Refractory Ovarian Carcinoma +26 more
Related terms Fallopian Tube Neoplasms, Ovarian Neoplasms
Enrollment 71 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov