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Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 20, 2026 → Mar 20, 2027
See other at-risk trials from Sumithira Vasu

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 20, 2026 to Mar 20, 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 20, 2026 to Jun 20, 2027
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site details revised at 1 of 2 sites
  2. Primary completion date: Feb 20, 2026 to Aug 20, 2026
    • Study completion date: Apr 20, 2026 to Dec 20, 2026
    v12
  3. Trial status: Suspended to Recruiting
    • Primary completion date: Oct 20, 2025 to Feb 20, 2026
    • Study completion date: Dec 20, 2025 to Apr 20, 2026
    • Site details revised at 2 of 2 sites
    v11
  4. Primary completion date: Mar 4, 2025 to Oct 20, 2025
    • Study completion date: Mar 4, 2025 to Dec 20, 2025
    v10
  5. Trial status: Recruiting to Suspended Sponsor's reason: Accrual goal reached
    • Primary and study completion dates: Dec 31, 2024 to Mar 4, 2025
    • Site details revised at 2 of 2 sites
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Enrollment target: 10 to 20v8 Show 6 more changesShow less
    • Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024
    • Interventions: Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes (Biological) to Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes (Biological), Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes…
    • Eligibility criteria expanded, about 95 words
    • Study description expanded, about 22 words
    • Study arms: 1 to 2
    • Study title expanded, about 3 words
  2. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v7
  3. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2022
    • Study title shortened, about 6 words
    • Collaborators shortened, about 4 words
    v6
  4. Enrollment target: 20 to 10
    • Start date: Jan 24, 2019 to Nov 7, 2020
    v5
  5. Study sites: 1 to 2v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 31, 2018 to Jan 24, 2019
    • Site details revised
    v3
  7. Start date: Oct 1, 2018 to Dec 31, 2018v2
  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.
Sumithira Vasu
3 trials monitored
See 1 trial at risk
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
Trial Details
NCT Number NCT03665675
Lead Sponsor Sumithira Vasu
Conditions
(from sponsor)		 Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus, Donor, Solid Organ Transplantation Recipient, Adenovirus
Related terms Adenoviridae Infections
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov