First line treatment-resistant Grade II to IV acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation
Conditions
Interventions
Intravenous of IMSUT-CORD with dose escalation by 3+3 design Cohort 1 dose:1x10^6cells /kg, Cohort 2 dose:2x10^6 cells /kg, Cohort -1 dose:5x10^5 cells /kg After safety confirmation at cohort
Sponsors
The Institute of Medical Science, The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients with grade II to IV acute GVHD. Pathological diagnosis is required, if possible. 2. Patients resistant to standard therapy with glucocorticoid. 3. Patients Aged 20 to 70 years at the time of consent 4. Patients who can give their consent by the written form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients NOT treated with standard first-line treatment with glucocorticoid for acute GVHD (except for prevention therapy for acute GVHD). 2. Patients treated with hematopoietic stem cell transplantation for hematopoietic malignancies under no remission, except for myelodysplastic syndrome with or without leukemic transition and myeloproliferative diseases. 3. Patients with following severe complications within 14 days before registration. a) Cardiac function: Ejection fraction <40% b) Pulmonary function: SpO2 < 90% or SpO2 < 95% under oxygen inhalation. c) Renal function: serum creatinine -> 2 times of upper limit of institutional normal range (ULN). d) Liver function: serum total bilirubin ->3 times of ULN, AST/ALT -> 5 times of ULN. 4. Pregnant/possible pregnant and nursing woman. Patients refuse to contraception. 5. Patients positive for HIV antibodies, HTLV-I antibodies, HBs antigen, and HCV antibodies. 6. Therapy resistant hypertension 7. Patient who have allergy against reagents used for processing, such as amphotericin B, gentamicin. Patients treated as emergency for adverse reaction of DMSO. 8.Investigators decision as not eligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: 1) Incidence of Dose Limited Toxicity (DLI) and determination of optical dose for phase II studies. 2) Evaluation of adverse events such as the rate of events, until 11 weeks after the last administration of IMSUT-CORD. 3) Statistical evaluation of laboratory tests until 11 weeks after the last administration of IMSUT-CORD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1) Overall response and change of stage/grading of organ damages by acute GVHD at 11 weeks after the last administration of IMSUT-CORD 2) Overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactCenter for Translational Research
The Institute of Medical Science, The University of Tokyo Center for Translational Research
Outcome results
None listed