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An Open Label, Non-Randomized Multicenter Phase 2b, Study with a Safety Run-in to Evaluate the Safety and Efficacy of RGI-2001 for the Prevention of Acute Graft Versus-Host Disease (aGvHD) Compared to Contemporary Controls in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)
Study of RGI-2001 (Investigational Drug) for Prevention of Acute Graft Versus-Host Disease (aGvHD) in Subjects after Stem Cell Transplant
| Sponsor: | REGiMMUNE |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAS6643 |
| U.S. Govt. ID: | NCT04014790 |
| Contact: | Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is to find out what effects (good and bad) an investigational (not approved by the Food and Drug Administration) drug, RGI-2001 has on you and graft-versus-host disease (GVHD). GVHD is a side effect of blood or bone marrow stem cell transplant that sometimes can be deadly. This study is trying to see if the experimental drug, RGI-2001 is safe and also whether it can help lower your chance of getting GVHD and perhaps make it less severe. This drug works by promoting a certain type of cells called regulatory T cells (Tregs) which can promote immune tolerance and thus lowering risks of GVHD.
This study is closed
