Trial Search Results

A Study of Engineered Donor Grafts (TregGraft/Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

The TregGraft includes other specific white blood cell populations – called regulatory T cells ("Treg") and conventional T cells ("Tcon").When given to transplant recipients, Treg are thought to prevent some of the known complications of blood cell transplants like graftversus-host disease, a potentially fatal condition that involves the immune attack on recipient tissues by donor cells. In contrast, Tcon cells may help eradicate infection or cancer, but also may increase the risk of graft versus host.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Orca Biosystems, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: Orca-T (formerly TregGraft)

Phase:

Phase 1

Eligibility


Key Inclusion Criteria:

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:

      - acute myeloid, lymphoid or mixed phenotype leukemia that is not in CR/CRi [Ages
      18-65]

      - myelodysplastic syndromes with > 10% to < 20% bone marrow blast burden [Ages
      18-65]

      - acute myeloid, lymphoid or mixed phenotype leukemia that is in CR/CRi but is
      categorized as DRI very high risk [Ages 18-65]

      - Myelofibrosis [Ages 18-65]

      - Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]

      - 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]

      - 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]

   2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor

   3. Estimated glomerular filtration rate (eGFR) > 50 mL/minute

   4. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by
   echocardiogram or radionuclide scan (MUGA)

   5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥
   50%

   6. 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

Key Exclusion Criteria:

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

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lindsay Danley
(650) 736-0304
Recruiting