Chronic graft-versus-host disease
Conditions
Interventions
treatment group:Sutacoumab Injection
Sponsors
The Second Affiliated Hospital of the Army Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years and <=70 years, both males and females eligible; 2. Patients with haematological malignancies or non-malignant conditions who have undergone allogeneic haematopoietic stem cell transplantation; 3. Post-transplant development of SR-cGVHD as defined by the 2014 NIH (National Institutes of Health), EBMT (European Society for Blood and Marrow Transplantation), and CIBMTR (Centre for International Blood and Marrow Transplant Research) guidelines; 4. Stable underlying disease with no progression or recurrence; 5. ECOG performance status 0–2; 6. Each study participant (or legally acceptable representative) voluntarily joins this study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with suspected hypersensitivity to secukinumab, similar agents, or any of their excipients; 2. Patients with post-transplant lymphoproliferative disorders; 3. Presence of multiple factors affecting subcutaneous drug administration (e.g., injection site erythema and oedema, inability to self-administer subcutaneous injections); 4. Patients with pathological evidence of disease recurrence prior to initiating second-line therapy, or where clinicians deem continued anti-rejection treatment inappropriate due to other factors; 5. Patients with active, uncontrolled viral infections such as CMV, EBV, HIV, HHV-6, HBV (HBsAg positive, HBV-DNA positive >=2000 IU/ml or 104 copies/ml), HCV (anti-HCV antibody or HCV-RNA positive), BK virus, or any clinically symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment; history of active tuberculosis within 6 months prior to screening; 6. Prior treatment with IL-17A-targeting agents (including for prevention or treatment of acute GVHD); 7. Concurrent malignancy undergoing treatment, or history of other malignancies within the preceding five years; 8. Severe cardiovascular disease (uncontrolled arrhythmia requiring treatment, QTc interval (QTcB) >480ms, congestive heart failure, NYHA Class III or IV, or symptomatic ischaemic heart disease); 9. Increase or decrease in immunosuppression within 4 weeks prior to treatment; 10. Other conditions deemed ineligible for inclusion by the investigator; Including: patients undergoing surgical procedures within the preceding 4 weeks who have not fully recovered; patients with epilepsy or those using psychotropic or sedative medications at screening; uncontrolled diabetes mellitus despite medication (fasting blood glucose >8.9 mmol/L); hypertension uncontrolled by two or fewer antihypertensive agents (systolic blood pressure 2.5 × ULN; DBIL and TBIL > 2.0 × ULN; serum creatinine > 1.5 × ULN; patients receiving anticoagulant or antiplatelet therapy (excluding low molecular weight heparin); patients who have used herbal medicines including ephedra, ginkgo, saw palmetto, or ginseng within one week prior to enrolment; 11. Lactating females, or patients who refuse to use effective contraception during the trial and for 4 weeks after the last dose; pregnant patients; 12. Participants who have enrolled in other clinical trials of investigational medicinal products or medical devices within 12 weeks prior to screening; or who have received donor lymphocyte infusion, CAR-T cell therapy, or CAR-NK cell therapy within the last 30 days; 13. Any participant deemed ineligible for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte subsets;Adverse Events;The proportion of patients who discontinued sacubitril due to toxicity or inability to tolerate it; | — |
Countries
China
Contacts
Public ContactZhang xi
The Second Affiliated Hospital of the Army Medical University
Outcome results
None listed