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A Phase 1 Study of Engineered Donor Grafts (OrcaGraft) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived From Mobilized Peripheral Blood (OrcaGraft), With Single Agent Graft Versus-host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies


Phase 1

DESCRIPTION:

Researchers at 3 research centers in CA are recruiting patients with leukemia (or other blood malignancies) to trial a new stem cell transplant product (OrcaGraft) where the stem cells are modified to remove certain types of cells that cause graft-versus-host disease.

Following screening and chemotherapy, the stem cells will be infused. Follow up will continue for at least 1 year.


PATIENT MUST:

  • Be 18 to 65 years of age
  • Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or High or very high risk myelodysplasic syndrome (MDS) including both of the following:
    • Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
    • Matched to a related or unrelated donor or to a haploidentical donor
  • Not have received prior allogeneic HCT

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. Admission to the hospital with chemotherapy to prepare the immune system.
  3. The engineered stem cells will be administered through an IV line.
  4. Follow up continues for ~365 days.

LOCATIONS & CONTACTS:
The study sites are City of Hope in Duarte, CA, Map, UC Davis in Sacramento, CA, Map, and Stanford Health Care in Stanford, CA, Map.
 
Contacts:
James S McClellan, MD, PhD  |  1-530-414-9743  |  [email protected]
 
SPONSORS
Orca Biosystems, Inc.
 
Or go online:
https://clinicaltrials.gov/show/NCT03802695

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