Persistent viral infection after Hematopoietic cell transplanation
Conditions
Interventions
Phase I study
Cohort 1: 2.0x10^7 cells /m2 of body surface area (m2) of MVST cells
Cohort 2: 1.0x10^7 cells /m2 of body surface area (m2) of MVST cells
Cohort 3: 0.5x10^7 cells /m2 of body surface are
Sponsors
Kamiya Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recipients who have received hematopoietic cell transplantation (regardless of source, HLA compatibility, or type of prior treatment) more than 30 days prior to enrollment. 2. One or more of intractable infections or diseases with CMV, EBV, ADV, BKPyV, JCPyV and HHV-6 longer than 7 days after diagnosis despite standard therapy. 3. Acute GVHD is grade I or under, and stable with corticosteroids (prednisolone) less than 0.5 mg/kg/day at enrollment. 4. Chronic GVHD is moderate or lower grade, with corticosteroids (prednisolone) less than 0.5 mg/kg/day at enrollment. 5. No noninfectious pulmonary complications (NIPCs) 6. i) Patients aged 20 years and older, ii) patients aged 16 to 19 and their representatives, or iii) representatives of patients aged 15 and under at enrollment, are capable of providing informed consent. 7. Representatives of patients, who are aged 20 or over but his/her whose representatives are necessary, are capable of providing informed consent according to the Act on the Safety of Regenerative Medicine.
Exclusion criteria
Exclusion criteria: 1. Patients who have been given anti-thymocyte globulin, Campath-1H, or other anti-T cell monoclonal antibodies within 28 days before enrollment. 2. Patients with severe uncontrollable infectious diseases other than CMV, EBV, ADV, BKPyV, JCPyV or HHV-6 infection. 3. Patients who have undergone administration of donor lymphocyte infusion within 28 days before enrollment. 4. Hematological malignancy indicated for HSCT is not in hematological remission (except for non-malignant disease status, such as primary immunodeficiencies). 5. Patients who had malignant tumors except for i) malignancy in remission for more than 5 years or ii) curatively resected gastrointestinal or skin cancer. 6. Ejection fraction by on echocardiography is less than 40%. 7. SpO2 on room air < 90% 8. Incidence of bronchiolitis obliterans (BO), or bronchiolitis obliterans syndrome (BOS) on high-resolution computed tomography. 9. Smoking after HSCT 10. Patients judged inappropriate to participate in the study for any other reason by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I study Incidence of adverse events of non-hematological toxicity, common terminology criteria for adverse events (CTCAE) version 5.0 grade 4 or higher, for 28 days after the final administration of MVSTs. Incidence of acute graft versus host disease (GVHD), grade III-IV according to the guideline of the Japan Society for Hematopoietic Cell Transplantation (JSHCT) version 5, for 42 days after the final administration of MVST cells. Phase II study Clinical efficacy against viral infections, and decreases in viral load (7, 14, 28, and 42 days after the first dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I study Clinical efficacy against viral infections, and decreases in viral load (7, 14, 28, and 42 days after the first dose) Virus-specific T cell count (7, 14, 28, and 42 days after the first dose) Overall survival rate (6 months and 12 months after the first administration) Phase II study Incidence of adverse events of non-hematological toxicity, common terminology criteria for adverse events (CTCAE) version 5.0 grade 4 or higher, for 28 days after the final administration of MVSTs. Incidence of acute graft versus host disease (GVHD), grade III-IV according to the guideline of the Japan Society for Hematopoietic Cell Transplantation (JSHCT) version 5, for 42 days after the final administration of MVST cells. Overall survival rate (after 6 and 12 months of the last administration) | — |
Countries
Japan
Contacts
Public ContactJun Kusano
Institute of Science Tokyo
Outcome results
None listed