A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Trial ID or NCT#

NCT03802695

Status

recruiting iconRECRUITING

Purpose

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Official Title

A Phase 1 Dose Escalation and Expansion Study of Orca-Q, an Engineered Donor Graft Derived From Mobilized Peripheral Blood, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age ≥ 18 and ≤ 65 years at the time of enrollment 2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS), myelofibrosis, or chronic myeloid leukemia 3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT) 4. Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor 5. Estimated glomerular filtration rate (eGFR) > 50 mL/minute 6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) 7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50% 8. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN Key
Exclusion Criteria:
  1. 1. Prior allogeneic HCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Planned donor lymphocyte infusion (DLI) 4. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor 5. Karnofsky performance score < 70% (Appendix 12.7) 6. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 (Appendix 12.8) 7. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 8. Seropositive for HIV-1 or -2, HTLV-1 or -2 9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 11. History of idiopathic or secondary myelofibrosis 12. Women who are pregnant or breastfeeding
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Investigator(s)

Parveen Shiraz, MD
Parveen Shiraz, MD
Blood and marrow transplant specialist, Hematologist-Oncologist
Instructor, Medicine - Blood & Marrow Transplantation

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Contact

Kelly Chyan
650-725-8130

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View on ClinicalTrials.gov