T Cell Therapy for Cytomegalovirus Infections
Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
This study is testing whether using special immune cells from donors can help patients who had a stem cell transplant fight off cytomegalovirus infections.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Months and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT02982902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients who have received an allogeneic hematopoietic stem cell transplant and have documented opportunistic CMV infections.
Not a fit: Patients who do not have CMV infections or are less than 30 days post-transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients suffering from CMV infections after stem cell transplants.
How similar studies have performed: Other studies have shown promise with similar adoptive T-cell therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.