NCT02982902

T Cell Therapy of Opportunistic Cytomegalovirus Infection

Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mari Dallas · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV. Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

Detailed description

The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system. Secondary Objective(s) * To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells. * To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells. * To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System. This feasibility study will include a single treatment cohort.

Conditions

• Cytomegalovirus Infections
• Hematopoietic Stem Cell Transplant
• Opportunistic Infections

Interventions

Type	Name	Description
BIOLOGICAL	CMV specific adoptive t-cells	It is expected that the cell dose will be in the range of 10\^3 - 10\^5 virus - specific, antigen selected T cells per kg of recipient weight.

Timeline

• Start date: 2020-05-27
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2016-12-06
• Last updated: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study