T Cell Therapy of Opportunistic Cytomegalovirus Infection

NCT02982902 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: CASE1Z16
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Immunotherapy; T-Cell Therapy; Lymphoproliferative Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  To determine the feasibility of the intervention, the study will record the incidence of adverse events, including graft versus host disease and other complications will be evaluated using binomial distribution theory and their 95% confidence intervals (CIs) will be also estimated using Wilson's method

  Up to 100 days after transplant

Secondary Outcomes (2)

• Eradication rate of opportunistic CMV infections

  Up to 100 days after transplant

• response rate

  Up to 100 days after transplant

Study Arms (1)

CMV specific adoptive t-cells

EXPERIMENTAL

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.

Biological: CMV specific adoptive t-cells

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.

Also known as: immunotherapy

CMV specific adoptive t-cells

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mari Dallas: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

RECRUITING

MeSH Terms

Conditions

Cytomegalovirus Infections; Opportunistic Infections; Lymphoproliferative Disorders

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Mari H Dallas, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mari H Dallas, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 6, 2016
• Study Start: May 27, 2020
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)