Clinical trial
Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant
Name
CASE1Z16
Description
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).
Trial arms
Trial start
2020-05-27
Estimated PCD
2024-09-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
CMV specific adoptive t-cells
Other names:
immunotherapy
Size
20
Primary endpoint
Incidence of adverse events
Up to 100 days after transplant
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-05-01
1 organization
1 product
3 indications
Organization
Mari DallasIndication
Cytomegalovirus InfectionsIndication
Hematopoietic stem cell transplantationIndication
Opportunistic Infections