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Anti-viral T-cell Therapy by Gamma Capture

Study acronym: Gamma Capture
StatusEnrolling by Invitation
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Jun 18, 2025, no change to tracked fieldsv7-v8
  2. Trial status: Recruiting to Enrolling by Invitation
    • Site details revised
    • Study description expanded, about 5 words
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2024 to Jan 8, 2024
    • Site details revised
    v5
  4. Start date: Dec 1, 2023 to Feb 1, 2024
    • Eligibility criteria revised
    v4
  5. Start date: Oct 1, 2023 to Dec 1, 2023v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Paul Szabolcs
9 trials monitored
See 2 trials at risk
The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥1/6 Human Leukocyte Antigens (HLA) -matched, viral specific T cells have efficacy against adenovirus, Cytomegalovirus (CMV), and Epstein Barr Virus (EBV) in subjects who have previously received any type of allogeneic Hematopoietic Cell transplant (HCT) or solid organ transplant (SOT) or have compromised immunity. Reconstitution of anti-viral immunity by donor-derived cytotoxic T lymphocytes has shown promise in preventing and treating infections with adenovirus, CMV, and EBV. However, the weeks taken to prepare patient-specific products, and cost associated with products that may not be used limits their value. This trial will evaluate viral specific T cells generated by gamma capture technology. Eligible patients will include HCT and/or SOT recipients, and/or patients with compromised immunity who have adenovirus, CMV, or EBV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.
Trial Details
NCT Number NCT06027879
Lead Sponsor Paul Szabolcs
Conditions
(from sponsor)		 Adenovirus, Cytomegalovirus Infections, Epstein-Barr Virus Infections
Related terms Adenoviridae Infections, Cytomegalovirus Infections, Epstein-Barr Virus Infections
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov