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ACTIVE NOT RECRUITING
NCT04364178
PHASE1/PHASE2

Viral Specific T-Lymphocytes to Treat Adenovirus or CMV

Sponsor: Jessie L. Alexander

View on ClinicalTrials.gov

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 and CMV 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 and CMV. 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 or CMV infection or refractory viremia that is persistent despite standard therapy. Infusion of the cellular product will be assessed for safety and efficacy.

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

Key Details

Gender

All

Age Range

1 Month - 65 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2020-08-12

Completion Date

2032-01-01

Last Updated

2024-05-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Adenovirus Specific T- Lymphocytes

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.

BIOLOGICAL

Cytomegalovirus Specific T-Lymphocytes

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.

Locations (2)

Jessie Alexander

Palo Alto, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States