Gamida Cell is developing novel cellular therapies for patients with hematologic malignancies and rare, serious blood disorders. We are committed to supporting healthcare professionals who care for these patients and share our goal of improving clinical outcomes.
Gamida Cell’s clinical development candidates, omidubicel1 and GDA-201, are designed to address areas of significant medical need.
Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
Our investigational product candidate, omidubicel, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant solution. We are currently enrolling a multi-center, international, randomized Phase 3 study to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood transplant in patients with high-risk hematologic malignancies, including leukemia, lymphoma and myelodysplastic syndrome, who need a bone marrow transplant but do not have a suitable matched donor. For more information about the study, please visit www.clinicaltrials.gov (NCT02730299).
Omidubicel is also being evaluated in an ongoing investigator-sponsored Phase 1/2 study in patients with severe aplastic anemia.2 For more information about the study, please visit www.clinicaltrials.gov (NCT03173937).
GDA-201 is a natural killer cell-based cancer immunotherapy. Through an investigator-sponsored Phase 1 study, GDA-201 is being evaluated in combination with antibodies in adult patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma. For more information about the study, please visit www.clinicaltrials.gov (NCT03019666).
1 Gamida Cell’s lead development candidate consists of omidubicel (expanded hematopoietic stem cells) and differentiated immune cells, including T cells. Gamida Cell refers to the two components collectively as “omidubicel.”
2 The Aplastic Anemia Investigational New Drug (IND) application is currently filed with the FDA under the brand name, CordIn, which is the same investigational development candidate as omidubicel.