Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity

Part of paid clinical trials in Palo Alto, California.

Sponsor
Jessie L. Alexander
Study ID
NCT06909110
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Adenovirus
  • Cytomegalovirus Infections
  • Epstein-Barr Virus Infections

Eligibility Criteria

Sex
ALL
Age
1 Month - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adenovirus Specific T- Lymphocytes — BIOLOGICAL
    Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
  • Cytomegalovirus Specific T-Lymphocytes — BIOLOGICAL
    Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
  • Epstein-Barr Virus Specific T-Lymphocytes — BIOLOGICAL
    Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Epstein-Barr viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
May 1, 2029
Completion
Jan 1, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Grade III-IV Acute Graft versus host disease [ Time Frame: Day 0 through 90 days after last cellular infusion ]

Locations (3)

FacilityCityStateZIPSite coordinators
Jessie AlexanderPalo AltoCalifornia94304-
Lucile Packard Children's HospitalPalo AltoCalifornia94304
Jessie L Alexander, MD
[email protected]
6507259250
Lucile Packard Children's HospitalPalo AltoCalifornia94305
SCGT Clinical Trials Program
[email protected]
650-723-0912

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Jessie Alexander· Palo Alto, CALucile Packard Children's Hospital· Palo Alto, CA

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