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Phase Ib study stage:
Primary objective: To evaluate the efficacy and safety Secondary objectives: To evaluate the population pharmacokinetic characteristics
Phase II study stage:
Primary objective: To evaluate the efficacy Secondary objectives: To evaluate the safety
Phase Ib study stage:
Primary objective: To evaluate the efficacy and safety of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the population pharmacokinetic characteristics of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy.
Phase II study stage:
Primary objective: To evaluate the efficacy of TDI01 suspension in treating patients with moderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy Secondary objectives: To evaluate the safety of TDI01 suspension in treating patients withmoderate or severe Chronic Graft-Versus-Host Disease after failure of at least 1 and not more than 5 lines of systemic therapy as well as the population pharmacokinetic characteristics of TDI01 suspension in treating these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 200mg | Active Comparator | 200mg oral once a day |
|
| 400mg | Active Comparator | 400mg oral once a day |
|
| 200mg or 400mg | Active Comparator | 200mg or 400mg oral once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TDI01 suspension | Drug | 200mg or 400mg oral once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib study stage:The best overall response rate (BORR) | The best overall response rate (BORR) at 24 weeks. | 24 weeks. |
| Phase Ib study stage:adverse events | The incidence of adverse events, including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and treatment-related adverse events (TRAEs). | 24 weeks. |
| Phase II study stage:The best overall response rate (BORR) | The best overall response rate (BORR) at 24 weeks. | 24 weeks. |
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Inclusion Criteria:
Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
Subjects are aged between 18 and 75 years old, regardless of gender;
Within 7 days prior to the first dose, the Eastern Cooperative Oncology Group (ECOG) performance status score is 0-2;
Subjects are expected to survive for more than 6 months;
Subjects have previously received allogeneic hematopoietic stem cell transplantation;
Subjects have received systemic treatment for cGVHD of ≤5 lines but ≥1 line before;
Diagnosed with moderate to severe cGVHD based on NIH criteria, defined as follows:
Moderate cGVHD: involvement of ≥3 organs with organ scores of 1 point, or involvement of ≥1 organ (excluding the lung) with organ scores of 2 points, or involvement of the lung with organ scores of 1 point; Severe cGVHD: involvement of ≥1 organ (excluding the lung) with organ scores of 3 points, or involvement of the lung with organ scores of 2 points or higher.
Diagnosed with glucocorticoid-resistant/dependent cGVHD based on NIH criteria, meeting any of the following conditions:
Subjects who have received at least 2 lines but no more than 5 lines in the past are required to have stable systemic therapy (such as corticosteroids, calcineurin inhibitors, sirolimus, mycophenolate mofetil (MMF), methotrexate, and extracorporeal phototherapy (ECP)) for at least two weeks prior to screening.
Subjects who have only received first-line glucocorticoid combined or not combined with calcineurin inhibitors in the past,Diagnosed as glucocorticoid resistant/dependent cGVHD according to NIH criteria, meeting any of the following conditions:
Subjects receiving ≥1 mg/kg prednisone (or equivalent dose of glucocorticoids) for at least 1 week but still have disease progression (glucocorticoid-resistant cGVHD); Subjects receiving ≥0.5 mg/kg/day or ≥1 mg/kg every other day prednisone (or equivalent dose of glucocorticoids) for at least 4 weeks but still have persistent disease symptoms without improvement ( glucocorticoid-resistant cGVHD); Subjects who have failed to reduce the glucocorticoid dose twice and have increased the prednisone (or equivalent dose of glucocorticoids) to >0.25 mg/kg/day (glucocorticoid-dependent cGVHD).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
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| D001982 |
| Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |