RecruitingEarly Phase 1NCT02982902

T Cell Therapy of Opportunistic Cytomegalovirus Infection

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


Sponsor

Mari Dallas

Enrollment

20 participants

Start Date

May 27, 2020

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 3 Months

Plain Language Summary

Simplified for easier understanding

This study tests whether infusing CMV-specific T cells — immune cells trained to fight cytomegalovirus (CMV) — can help stem cell transplant recipients who develop a CMV infection that does not respond to standard antiviral medications. CMV can be life-threatening in people with weakened immune systems after a transplant. You may be eligible if: - You have received an allogeneic (donor) stem cell transplant at least 30 days ago - You have documented CMV infection or reactivation with a viral load above 1,000 copies/mL, and/or CMV-related symptoms - Standard antiviral treatment (ganciclovir, valganciclovir, or foscarnet) has not worked, caused side effects, or your CMV has come back a second time - You are aged 3 months or older - You are willing to use contraception if applicable You may NOT be eligible if: - You are pregnant or breastfeeding - You have active moderate-to-severe graft-versus-host disease (GVHD) or require high-dose steroids - You have received antithymocyte globulin within the past 28 days - You have a viral infection other than CMV that is opportunistic Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCMV 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.


Locations(1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT02982902


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