Recruiting
Early Phase 1

T Cell Therapy

Sponsor:

Mari Dallas

Code:

NCT02982902

Conditions

Cytomegalovirus Infections

Hematopoietic Stem Cell Transplant

Opportunistic Infections

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

CMV specific adoptive t-cells

Study Details

Brief 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

Study ID

NCT02982902

Start date

May 27, 2020

Status verified date

Sep, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
  • Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)

  • Patients may have asymptomatic viremia (>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
  • Patients must have ONE OF THE NEXT FOUR CRITERIA:

  • Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
  • New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
  • Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
  • Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
  • Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.

Exclusion Criteria:

  • Pregnant or breastfeeding women are excluded from this study.
  • Patients with opportunistic viral infections other than CMV.
  • Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (>0.5 mg/kg/day prednisone or its equivalent) as treatment
  • Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
  • Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.

Donor eligibility

  • Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
  • Must have evidence of a serologic response (i.e. be seropositive) against CMV.
  • Age ≥ 18 years
  • Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
  • Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Mari H Dallas, MD

1-800-641-2422CTUReferral@UHhospitals.org

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106-5065

Contacts

Mari H Dallas, MD

1-800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Mari H Dallas, MD

More Information

Sponsor

Mari Dallas

Last update posted

Oct 22, 2025

Last verified

Sep, 2025

Keywords

  • Immunotherapy
  • T-Cell Therapy
  • Lymphoproliferative Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mari Dallas on 2025-10-22.