T Cell Therapy for Cytomegalovirus Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of using donor-derived T-cells that specifically target cytomegalovirus (CMV) to treat opportunistic CMV infections in patients who have undergone hematopoietic stem cell transplantation. The approach involves selecting and infusing these T-cells into patients to enhance their immune response against the infection. The study will also assess the safety profile and potential toxicities associated with this treatment, as well as the effectiveness in eradicating CMV infections post-transplant.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Mari H Dallas, MD — University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
• Study coordinator: Mari H Dallas, MD
• Email: CTUReferral@UHhospitals.org
• Phone: 1-800-641-2422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early Cognitive Behavioral Therapy for Insomnia Before Stem Cell Transplant

  This trial tests whether starting six telehealth CBT-I sessions before hematopoietic stem cell transplant can help adults with insomnia feel better and have less fatigue.

  Recruiting Phase 1 University of Kansas Medical Center · Kansas City, Kansas · NCT07774039

• CMV-specific T cells after CMV reactivation in adults after HSCT

  This study tests CMV-specific immune recovery in adults who have their first CMV reactivation after an allogeneic HSCT to see how CMV-specific T cells change over time.

  Recruiting The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07688759

• Biomarkers linked to congenital CMV using newborn blood spots

  Researchers will test protein and RNA markers in dried blood spots from newborns to see if they can identify congenital CMV sequelae early.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 1 other locations · NCT07635368

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

• Family-donor viral CTLs plus standard care vs standard care alone for refractory ADV or CMV infection after stem cell transplant

  This study tests whether using family-donor virus-specific CTLs in addition to usual treatment helps children, teens, and young adults with hard-to-treat CMV or adenovirus infections after a stem cell transplant.

  Recruiting Phase 3 New York Medical College · Valhalla, New York and 1 other locations · NCT07225972

• CMV-specific immunoglobulin to prevent CMV problems in children getting allogeneic stem cell transplants

  Doctors will try giving CMV-specific immunoglobulin to children having allogeneic stem cell transplants to prevent CMV reactivation and related transplant complications.

  Recruiting University of Pisa · Trieste · NCT07013370

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.