Third-party derived multiple virus specific T-cell therapy for drug-resistant virus infection post hematopoietic cell transplantation - TP-MVST therapy for drug-resistant virus infection post HCT

Morio Tomohiro0 个研究点目标入组 21 人开始时间: 2023年9月1日最近更新: 2023年10月17日

试验速览

暂无简介。

•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.

•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.

发起方

Morio Tomohiro