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Remestemcel-L-rknd · 1 trial · 1 indication
The primary clinical endpoint is overall response at Day 28 post-randomization. Overall response is defined as achieving a PR or CR on Day 28 post-randomization without requirement for new intervening systemic immunosuppressive therapies
| Arm | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | EXPERIMENTAL | Remestemcel-L will be administered as intravenous infusions |
| Placebo | PLACEBO_COMPARATOR | PTM will be administered as intravenous infusions |
| Name | Type | Description |
|---|---|---|
| Remestemcel-L-rknd | DRUG | Remestemcel-L is comprised of ex-vivo cultured adult human MSC |
| Placebo | OTHER | Placebo is infusion based to be given at the same points as remestemcel-L-rknd |
Inclusion Criteria: 1. Age 18 years or older at the time of enrollment. 2. Able to take oral medications 3. Have Grade III-IV SR-aGVHD at the time of enrollment, defined as aGVHD resistant to high dose corticosteroids at a dose of ≥ 1 mg/kg/day methylprednisolone (or equivalent), given alone or in ...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Belumosudil |
| Incyte Corporation | INCY | 10 | PHASE3 | INCA034176, Ruxolitinib, Axatilimab |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
Remestemcel-L-rknd is an investigational cell therapy being developed by Mesoblast Limited for graft-versus-host disease, or GVHD. It is in Phase 3 clinical development and is not yet approved. The program focuses on steroid-refractory acute GVHD, a serious complication that can occur after stem cell or bone marrow transplant.
Remestemcel-L-rknd is being studied for Grade III-IV steroid-refractory acute graft-versus-host disease, or GVHD. It is added to ruxolitinib in the ongoing Phase 3 trial. GVHD is a condition in which donor immune cells attack the recipient's tissues, and steroid-refractory cases are those that do not respond adequately to steroid treatment.
Remestemcel-L-rknd is being developed by Mesoblast Limited, which trades under the ticker MESO. The company is running the Phase 3 program for the asset in steroid-refractory acute graft-versus-host disease.
Remestemcel-L-rknd is in Phase 3 clinical development. It is an investigational cell therapy and has not been approved by the FDA. The Phase 3 trial is currently listed as not yet recruiting, with a planned enrollment of 180 participants.
Remestemcel-L-rknd is being evaluated in one Phase 3 trial, NCT07568535. The study is a randomized, double-blind, placebo-controlled, multicenter trial of remestemcel-L-rknd added to ruxolitinib for Grade III-IV steroid-refractory acute graft-versus-host disease. It plans to enroll 180 adults aged 18 years and older and is not yet recruiting.