T Cell Therapy of Opportunistic Cytomegalovirus Infection
NCT02982902 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-10-22
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).
Conditions
- Cytomegalovirus Infections
- Hematopoietic Stem Cell Transplant
- Opportunistic Infections
Interventions
- 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.
Sponsors & Collaborators
-
Mari Dallas
lead OTHER
Principal Investigators
-
Mari H Dallas, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 3 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-27
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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