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Gamida Cell is developing next-generation cell therapies with curative potential for patients with cancer and other serious diseases. We are committed to supporting healthcare professionals who care for patients and share our goal of improving clinical outcomes.

Clinical Trials

Gamida Cell’s clinical development candidates, omidubicel and GDA-201, are designed to address areas of significant medical need. Read more about ongoing clinical trials of these investigative therapies below. For more information or questions, please contact us.

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.

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Omidubicel for hematologic malignancies

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Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU.

Omidubicel has been studied in an international, multi-center, randomized Phase 3 clinical study evaluating its the safety and efficacy compared to standard umbilical cord blood transplant.

  • The study achieved its primary endpoint (p<0.001). In the intent-to-treat analysis, median time to neutrophil engraftment was 12 days for patients receiving omidubicel (95% CI: 10-15 days) compared to 22 days for the comparator group (95% CI: 19-25 days).
  • Omidubicel was generally well tolerated. Among patients who were transplanted per protocol, rates of acute and chronic graft-versus host disease were similar and cumulative incidence of infections was significantly smaller in omidubicel compared to controls for both viral infections and bacterial or invasive fungal infections.
  • The study also met all three of its secondary endpoints, improving platelet engraftment, and reductions in infections and hospitalizations, which are key measures for success for bone marrow transplant.

The Phase 3 data also show that during the first 100 days of treatment, omidubicel-treated patients had significantly shorter durations of hospitalization, intensive care unit time, consultant visits, procedures, and transfusions than the control arm. These data provide further evidence of the clinical benefit associated with the more rapid hematopoietic recovery in patients treated with omidubicel and the corresponding reduction in healthcare resource utilization.

Full safety and efficacy data from this Phase 3 study have been published in Blood.

We expect to initiate the submission of a biologics license application (BLA) filing in the first half of 2022. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia, a rare and life-threatening blood disorder.

Omidubicel for severe aplastic anemia

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Omidubicel is also being evaluated in an ongoing investigator-sponsored Phase 1/2 study in patients with severe aplastic anemia. For more information about the study, please visit www.clinicaltrials.gov (NCT03173937).

GDA-201

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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).

GRANTS & SPONSORSHIPS

Gamida Cell is proud to work with the scientific community to advance research that aligns with our mission of delivering curative new treatments for patients with cancer and other serious diseases. For more information about Gamida Cell medical education grants and sponsorships, please contact us.

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