T Cell Therapy of Opportunistic Cytomegalovirus Infection

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Mari Dallas
Study ID
NCT02982902
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cytomegalovirus Infections
  • Hematopoietic Stem Cell Transplant
  • Opportunistic Infections

Eligibility Criteria

Sex
ALL
Age
3 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • CMV specific adoptive t-cells — BIOLOGICAL
    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.

Study Details

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).

Key Dates

Start date
May 27, 2020
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CMV specific adoptive t-cells
    This study involves a one-time infusion of the experimental CMV specific adoptive t-cells. After this infusion, patients will be followed for 4 weeks.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 100 days after transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065
Mari H Dallas, MD
[email protected]
1-800-641-2422
Mari H Dallas, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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