Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

Official Title

A Multicenter Phase Ib Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Orca-T (Formerly TregGraft), a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells

Keywords

Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndromes, Acute Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia, Chronic Phase, hematopoietic stem cell transplantation, matched related donor, matched unrelated donor, Leukemia, Leukemia, Myeloid, Preleukemia, Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphoid, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Orca-T (formerly TregGraft)

Eligibility

You can join if…

Open to people ages 18-75

Recipients must meet all of the following criteria:

  1. Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
  2. acute myeloid, lymphoid or mixed phenotype leukemia that is not in CR/CRi [Ages 18-65]
  3. myelodysplastic syndromes with > 10% to < 20% bone marrow blast burden [Ages 18-65]
  4. acute myeloid, lymphoid or mixed phenotype leukemia that is in CR/CRi but is categorized as DRI very high risk [Ages 18-65]
  5. Myelofibrosis [Ages 18-65]
  6. Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]
  7. acute myeloid, lymphoid, mixed phenotype leukemia or myelodysplastic syndromes (therapy-related/secondary MDS or eligible for alloHCT per 2017 International Expert Panel) that are in CR and intermediate to high risk per the DRI in patients aged 66 to 75 [Ages 66-75]
  8. chronic myeloid leukemia that is in chronic phase with history of blast crisis or accelerated phase and/or is resistant to or intolerant of >1 first- or second-generation TKI [Ages 18-65]
  9. Patients must be matched to a 8/8 HLA-matched related or unrelated donor
  10. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  11. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  12. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  13. Total bilirubin < 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST < 3 times ULN

You CAN'T join if...

Recipients meeting any of the following exclusion criteria will not be eligible:

  1. History of 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. Pre-planned donor lymphocyte infusion (DLI)
  4. Planned pharmaceutical in vivo or ex vivo T cell depletion
  5. Positive for anti-donor HLA antibodies against an allele in the selected donor
  6. Karnofsky performance score < 70%
  7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  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 HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
  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. . Women who are pregnant or breastfeeding

Locations

  • UC Davis accepting new patients
    Sacramento California 95817 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.
Links
Sign up for this study
ID
NCT04013685
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 255 study participants
Last Updated