Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥ 18 and ≤ 65 years at the time of enrollment 2. Diagnosed acute myeloid, lymphoid or mixed phenotype leukemia, or high or very high risk myelodysplasic syndrome (MDS) or Myelofibrosis 3. Planned to undergo myeloablative allogeneic hematopoietic stem cell transplant (HCT) 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 6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA) 7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50% 8. Total bilirubin < 1.5 times upper limit of normal (ULN) (< 3 times if attributed to Gilbert's syndrome) and ALT/AST < 3 times ULN

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
Recipients with HLA-identical or 1-allele mismatched (7/8 alleles) related or unrelated donor; with single-agent GVHD prophylaxis given
  • Biological: OrcaGraft (Orca-Q)
    engineered donor allograft
Experimental
Arm B
Recipients with haploidentical-related donors; with single-agent GVHD prophylaxis given
  • Biological: OrcaGraft (Orca-Q)
    engineered donor allograft
Experimental
Arm C
Recipients with an HLA-identical related or unrelated donor; no GVHD prophylaxis given
  • Biological: OrcaGraft (Orca-Q)
    engineered donor allograft

Recruiting Locations

The University of Kansas Hospital
Kansas City, Kansas 66160
Contact:
Joseph McGuirk, MD

More Details

Status
Recruiting
Sponsor
Orca Biosystems, Inc.

Study Contact

James S McClellan, MD, PhD
1-530-414-9743
info@orcabiosystems.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.