Persistent viral infection after Hematopoietic cell transplanation
Conditions
Interventions
MVSTs for 5 viruses at 1.0xE07, 2.0xE07, and 5.0xE07cells/m2 BSA as follows.
(MVST : multi-virus specific T cell, BSA : body surface area)
Cohort 1: administration of 1.0xE07 MVSTs per BSA (m2)
Cohor
Sponsors
Morio Tomohiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Recipients who have received prior myeloablative or nonmyeloablative allogeneic HSCT with bone marrow, cord blood, or peripheral blood stem cells between 30 days and 12 months before enrollment. 2. One or more of intractable infections or diseases with CMV, EBV, ADV, BKV, 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, BKV, 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 =500U/mL for patients 16 years and older, and >=250U/mL for patients below the age of 16. 11. Smorking after HSCT 12. Patients judged inappropriate to participate in the study for any other reason by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events of non-hematological toxicity, common terminology criteria for adverse events (CTCAE) version 4.0 grade 4 or higher, for 30 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 4, for 45 days after the final administration of MVSTs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the recommended cell dose for MVST administration. Incidence of chronic GVHD according to the guideline of the JSHCT for 1 year after the final administration of MVSTs. Reduction rate of viral load and improvement of clinical signs and symptoms for 30 days after the final administration of MVSTs. Number of VSTs in blood at 2, 4, and 12 weeks after the final MVST administration. Improvement of clinical signs and symptoms due to viral infection at 6 and 12 weeks after the final MVST administration. Overall survival rate at 6 and 12 months after the final MVST administration. | — |
Countries
Japan
Contacts
Public ContactJun Kusano
Tokyo Medical and Dental University
Outcome results
None listed