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 to 65
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age ≥ 18 and ≤ 65 years at the time of enrollment2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS), myelofibrosis, or chronic myeloid leukemia3. 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 donor5. Estimated glomerular filtration rate (eGFR) \> 50 mL/minute6. 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
    1. Key Exclusion Criteria:
  2. 1. Prior allogeneic HCT2. 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 donor5. 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 enrollment8. Seropositive for HIV-1 or -2, HTLV-1 or -29. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected11. History of idiopathic or secondary myelofibrosis12. Women who are pregnant or breastfeeding
Exclusion Criteria:
  1. 1. Prior allogeneic HCT2. 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 donor5. 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 enrollment8. Seropositive for HIV-1 or -2, HTLV-1 or -29. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment10. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected11. History of idiopathic or secondary myelofibrosis12. Women who are pregnant or breastfeeding
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Investigator(s)

Hany Elmariah
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Parveen Shiraz
Parveen Shiraz
Blood and marrow transplant specialist, Hematologist-Oncologist
Instructor, Medicine - Blood & Marrow Transplantation
Everett Meyer
Everett Meyer
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist, Transplant immunologist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy), of Pediatrics (Stem Cell Transplantation) and, by courtesy, of Surgery (Abdominal Transplantation)
Robert Lowsky
Robert Lowsky
Blood and marrow transplant specialist, Hematologist, Blood and marrow transplant specialist
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Kelly Chyan
650-725-8130

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View on ClinicalTrials.gov