Summary

for people ages 18-65 (full criteria)
at UC Davis
study started
estimated completion

Description

Summary

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft") 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), 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 Leukemia, Myeloid, Acute Preleukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid OrcaGraft Related and unrelated HLA-matched donors Haploidentical donors

Eligibility

For people ages 18-65

Key Inclusion Criteria:

  1. Age ≥ 18 and ≤ 65 years at the time of enrollment
  2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) or
  3. High or very high risk myelodysplasic syndrome (MDS) including both of the following:
  4. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT)
  5. Matched to a related or unrelated donor or to a haploidentical donor
  6. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  7. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  8. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  9. 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:

  1. Prior allogeneic HCT
  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. Positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  5. 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 enrollment
  8. Seropositive for HIV-1 or -2, HTLV-1 or -2
  9. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  10. . Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  11. . History of idiopathic or secondary myelofibrosis
  12. . Women who are pregnant or breastfeeding

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States
  • Stanford Health Care accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Orca Biosystems, Inc.
ID
NCT03802695
Phase
Phase 1
Study Type
Interventional
Last Updated