A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
a study on Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome Hematologic Malignancy Allogeneic Hematopoietic Cell Transplantation Hematopoietic Cell Transplantation
Summary
- Eligibility
- for people ages 12-78 (full criteria)
- Location
- at UC Davis
- Dates
- study startedstudy ends around
Description
Summary
This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) 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 Allogeneic Hematopoietic Cell Transplantation for Hematologic Malignancies
Keywords
Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, OrcaGraft (Orca-Q)
Eligibility
You can join if…
Open to people ages 12-78
- Age ≥ 12 and ≤ 78 years at the time of enrollment
- Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS) either in complete remission (CR) or with ≤ 10 percent of blast cells in bone marrow (BM)
- Planned to undergo allogeneic hematopoietic stem cell transplant (alloHCT)
- 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 (MAC with tacrolimus) or > 30 mL/minute (NMA/RIC or MAC without tacrolimus)
- Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC)
- Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC
- Liver function: Total bilirubin < 1.5 times upper limit of normal (ULN) (MAC) or < 3 times ULN (NMA/RIC); alanine transaminase (ALT)/aspartate transaminase (AST) < 3 times ULN (MAC) or < 5 times ULN (NMA/RIC)
- Participants enrolling on NMA/RIC-alloHCT arms must be deemed unfit for a myeloablative alloHCT per assessment of the principal investigator (PI)
You CAN'T join if...
- Prior alloHCT
- 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)
- Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab
- Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
Low performance score: For MAC: Karnofsky Performance Score (KPS) < 70 percent, For
NMA/RIC: <60 percent
- High HCT-specific Comorbidity Index (HCT-CI): For MAC > 4, For NMA/RIC >6
- Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- Seropositive for human immunodeficiency virus (HIV)-1 or -2, human T-lymphotropic virus (HTLV)-1 or -2 or Hepatitis B surface antigen (HbsAg) or anti-Hepatitis C virus (HCV) antibody (Ab)
- 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
accepting new patients
Sacramento 5389489 California 5332921 95817 United States - City of Hope
accepting new patients
Duarte 5344147 California 5332921 91010 United States - Stanford Health Care
accepting new patients
Stanford 5398563 California 5332921 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Orca Biosystems, Inc.
- ID
- NCT03802695
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 300 study participants
- Last Updated