Viral Specific T-Lymphocytes by Cytokine Capture System (CCS) to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus After Hematopoietic Cell Transplantation or Solid Organ Transplantation and in Patients With Compromised Immunity

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The primary purpose of this phase I/II study is to evaluate whether partially matched, ≥2/6 HLA-matched, viral specific T cells have efficacy against adenovirus, CMV, and EBV, in subjects who have previously received any type of allogeneic 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. In this trial, we 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 65
Healthy Volunteers: f
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Locations
United States
California
Jessie Alexander
COMPLETED
Palo Alto
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Lucile Packard Children's Hospital
RECRUITING
Palo Alto
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2032-01-01
Participants
Target number of participants: 25
Treatments
Experimental: Viral Specific T-Lymphocytes
Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS® Plus where they will be stimulated in vitro with viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system. By this method, viral specific, gamma-secreting T cells, are captured in a closed, sterile system.
Sponsors
Leads: Jessie L. Alexander

This content was sourced from clinicaltrials.gov