Summary

Eligibility
for people ages 12-78 (full criteria)
Location
at UC Davis
Dates
study started
study 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

  1. Age ≥ 12 and ≤ 78 years at the time of enrollment
  2. 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)
  3. Planned to undergo allogeneic hematopoietic stem cell transplant (alloHCT)
  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 (MAC with tacrolimus) or > 30 mL/minute (NMA/RIC or MAC without tacrolimus)
  6. Cardiac parameters: Cardiac ejection fraction ≥ 45 percent (MAC) or ≥ 40 percent (NMA/RIC)
  7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50 percent for MAC or ≥ 40 percent for NMA/RIC
  8. 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)
  9. 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...

  1. Prior alloHCT
  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. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy) or alemtuzumab
  5. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  6. Low performance score: For MAC: Karnofsky Performance Score (KPS) < 70 percent, For

    NMA/RIC: <60 percent

  7. High HCT-specific Comorbidity Index (HCT-CI): For MAC > 4, For NMA/RIC >6
  8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
  9. 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)
  10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  12. History of idiopathic or secondary myelofibrosis
  13. 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