A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)
a study on Acute Myeloid Leukemia Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome
Summary
- Eligibility
- for people ages 18-65 (full criteria)
- Location
- at UC Davis
- Dates
- study started
Description
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.
Official Title
A Phase 1, Dose Escalation and Expansion Study of Engineered Donor Grafts Derived From Mobilized Peripheral Blood (OrcaGraft/Orca-Q), With Single Agent Graft Versus-host Disease Prophylaxis, in Recipients Undergoing Myeloablative Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Keywords
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Acute Leukemia Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Neoplasms OrcaGraft (Orca-Q)
Eligibility
You can join if…
Open to people ages 18-65
- Age ≥ 18 and ≤ 65 years at the time of enrollment
- 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
- 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
You CAN'T join if...
- 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
Locations
- UC Davis
not accepting new patients
Sacramento California 95817 United States - City of Hope
not accepting new patients
Duarte California 91010 United States - Stanford Health Care
not accepting new patients
Stanford California 94305 United States
Details
- Status
- not accepting new patients
- Start Date
- Sponsor
- Orca Biosystems, Inc.
- ID
- NCT03802695
- Study Type
- Expanded Access
- Last Updated