Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04738981 | Efficacy and Safety of UC-MSCs for the Treatment of Steroid-resistant aGVHD Following Allo-HSCT | PHASE3 | COMPLETED | 130 | — | — | Feb 1, 2021 | May 2, 2023 | Jun 1, 2023 | 1 | China |
Complete remission of aGVHD related symptoms and indicators
| Arm | Type | Description |
|---|---|---|
| UC-MSC and anti-CD25 mAb | EXPERIMENTAL | UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment. |
| Anti-CD25 mAb | ACTIVE_COMPARATOR | Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment. |
| Name | Type | Description |
|---|---|---|
| UC-MSC | DRUG | UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks. |
| Anti-CD25 mAb | DRUG | Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. |
Inclusion Criteria: * 1.Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10\^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent. Exclusion Criteria: \- 1. Untoleratation of the treatment. ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 11 | PHASE3 | INCA034176, Tacrolimus, Methotrexate, Ruxolitinib, Cyclophosphamide |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | Belumosudil, Prednisone, Prednisolone |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Theriva Biologics, Inc. | TOVX | 1 | PHASE1 | Undisclosed |
| Novartis AG Sponsored ADR | NVS | 1 | — | Undisclosed |