Acute Myeloid Leukemia Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Age ≥ 18 and ≤ 65 years at the time of enrollment
Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS), myelofibrosis, or chronic myeloid leukemia
Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
Matched to a 8/8 or 7/8 related or unrelated donor, or to a related haploidentical donor
Estimated glomerular filtration rate (eGFR) > 50 mL/minute
Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
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:

Prior allogeneic HCT
Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
Planned donor lymphocyte infusion (DLI)
Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
Karnofsky performance score < 70% (Appendix 12.7)
Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4 (Appendix 12.8)
Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
Seropositive for HIV-1 or -2, HTLV-1 or -2
Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
History of idiopathic or secondary myelofibrosis
Women who are pregnant or breastfeeding

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

186

Study ID:

NCT03802695

Recruitment Status:

Recruiting

Sponsor:

Orca Biosystems, Inc.

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Amandeep Salhotra, MD
Contact
UC Davis
Sacramento California, 95817, United States More Info
Mehrdad Abedi, MD
Contact
Stanford Health Care
Stanford California, 94305, United States More Info
Robert Lowsky, MD
Contact
Emory University
Atlanta Georgia, 30322, United States More Info
Edmund Waller, MD
Contact
The University of Kansas Hospital
Kansas City Kansas, 66160, United States
Ohio State University
Columbus Ohio, 43210, United States More Info
Ayman Saad, MD
Contact
University of Texas MD Anderson Cancer Center
Houston Texas, 77054, United States More Info
Samer Srour, MD
Contact
Froedtert Memorial Lutheran Hospital
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

186

Study ID:

NCT03802695

Recruitment Status:

Recruiting

Sponsor:


Orca Biosystems, Inc.

How clear is this clinincal trial information?

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