acute graft-versus-host disease
Conditions
Interventions
group 1:CAStem cell injection 1E6 cells/kg, 1/w×3w
group 2:CAStem cell injection 3E6 cells/kg, 1/w×3w
group 3:CAStem cell injection 1E6 cells/kg, 2/w×2w
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: aGVHD patients diagnosed with grade II to IV (except grade II with skin involvement only) after allogeneic hematopoietic stem cell transplantation failed glucocorticoid therapy.
Exclusion criteria
Exclusion criteria: 1. History of severe allergy; 2. Those who have previously received stem cell transfusions for the treatment of GVHD; 3. Patients who have received allogeneic hematopoietic stem cell transplantation for more than 2 times (including 2 times) or have received Donor lymphocyte infusion (DLI) or other immune cells (including but not limited to CAR-T, TCR-T, etc.) after transplantation; 4. Patients with recurrent primary disease during the screening period; 5. There is a history of other malignant tumors other than the primary disease, or severe atypical growth without treatment; 6. Patients who developed deep vein thrombosis or pulmonary embolism within 3 months prior to screening and were deemed unfit to participate in the study; 7. Those who currently have severe unstable arrhythmia and are considered unfit to participate in the study; 8. Currently have active infectious diseases, including but not limited to positive human immunodeficiency virus (HIV) antibodies, active tuberculosis or syphilis in the infectious period, or other active infectious diseases deemed unsuitable for participation in this test; 9. Body mass index (BMI) >= 40 kg/m2; 10. Women who are pregnant or nursing or plan to become pregnant during the study, or women or men of childbearing age who are not willing to use contraception throughout the trial; 11. Treatment with another investigational drug within 28 days prior to initiation of treatment, and the investigational drug in question is determined by the investigator to interfere with the evaluation of the safety and efficacy of the investigational drug; 12. Other circumstances in which the investigator believes that participation in this study is not in the best interest of the subjects or is not suitable for participation in this study, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall reaction rate, ORR ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sustained complete response rate, cCR;Incidence of chronic graft-versus-host disease;Overall survival, OS;Recurrence rate of acute graft-versus-host disease;Recurrence rate of primary disease;The incidence of serious infections;lymphocyte subpopulation;immune globulin; | — |
Countries
China
Contacts
Public ContactTing Niu
West China Hospital of Sichuan University
Outcome results
None listed