Recruiting
Early Phase 1

Antigen Specific T Cell Therapy

Sponsor:

Mari Dallas

Code:

NCT03378102

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

IFN-gamma-secreting HAdV antigen specific T cells

Study Details

Brief summary:

The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy.

Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into 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

Allogeneic Hematopoietic Stem Cell Transplantation

Study ID

NCT03378102

Start date

Jan 4, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.
  • Patients must have evidence of documented HAdV infection/reactivation. Patients may be:

  • Symptomatic with any detectable viral load OR
  • Asymptomatic with viral load that is:

>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens

  • Patients must have poor response and/or contraindication to therapy:

  • Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR
  • New, persistent and/or worsening HAdV-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, cidofovir or foscarnet.
  • Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (<16 years) performance score ≥ 50
  • The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, 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 who are 14 years and older 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. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial.
  • Patients with opportunistic viral infections other than HAdV.
  • Patients with active, grade II-IV, acute graft versus 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Interferon (IFN)-gamma-secreting HAdV antigen specific T cells

Virus-specific, antigen selected cells will be obtained using the CliniMACS® Prodigy System. The donor will be screened for their ability to produce an IFN-gamma- secretion response to HAdV by testing the donor's mononuclear cells with the Miltenyi Rapid Cytokine Inspector kit. Donors with appropriate IFN-gamma secretion response will undergo a steady state leukapheresis. The investigational product (IP) will be generated using the CCS-IFN enrichment program with an approximate duration time of 15 hours. IP will be suspended in 0.9 normal saline + 2.5% albumin and distributed for infusion and infused within 4 hours as a bolus on day 0.

Subjects will receive virus-specific, antigen selected T cells within a targeted range of 1 x 10\^3- 2 x 10\^5 per kg of recipient weight.

Interventions

IFN-gamma-secreting HAdV antigen specific T cells

Antigen selected cells will be obtained using the CliniMACS(R) Prodigy System from a compatible donor. Isolated cells will be infused into the donor to treat human adenoviral infection after transplant

Primary outcome measure

  • Number of patients with severe adverse events [ Time Frame: Up to 100 days after infusion ]

Central Contacts and Locations

Central contacts

Mari H Dallas, MD

216-844-0139mhd27@case.edu

Locations

University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Mari H Dallas, MD

216-844-0139mhd27@case.edu

Principal Investigator:

Mari H Dallas, MD

More Information

Sponsor

Mari Dallas

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • T Cell Therapy
  • Opportunistic Infection

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 2026-06-04.