A Study of Engineered Donor Grafts (TregGraft) for Allogeneic Transplantation for Hematologic Malignancies (blood cancer)
a study on Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome
Summary
- Eligibility
- for people ages 18-65 (full criteria)
- Location
- at UC Davis UCLA
- Dates
- study startedestimated completion
Description
Summary
This study will evaluate the safety, tolerability, and efficacy of an engineered donor graft ("TregGraft"/"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 for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With TregGraft (Orca-T), 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 hematopoietic stem cell transplantation matched related donor matched unrelated donor Leukemia Preleukemia Hematologic Neoplasms Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma TregGraft (Orca-T)
Eligibility
You can join if…
Open to people ages 18-65
Recipients must meet all of the following criteria:
- 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
- high or very high risk myelodysplastic syndromes
- Patients with active acute leukemia (i.e. not in morphologic complete response) must have bone marrow infiltration by leukemic blasts of <= 10%,
- Patients must be matched to a related or unrelated donor
- Estimated glomerular filtration rate (eGFR) > 50 mL/minute
- Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
- Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
- 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:
- History of prior allogeneic HCT
- Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
- Pre-planned donor lymphocyte infusion (DLI)
- Planned pharmaceutical in vivo or ex vivo T cell depletion
- Positive for anti-donor HLA antibodies against an allele in the selected donor
- Karnofsky performance score < 70%
- Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
- Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
- . Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
- . Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
- . Women who are pregnant or breastfeeding
Locations
- Ronald Reagan UCLA Medical Center
accepting new patients
Los Angeles California 90095 United States - UC Davis
accepting new patients
Sacramento California 95817 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Orca Biosystems, Inc.
- ID
- NCT04013685
- Phase
- Phase 1
- Study Type
- Interventional
- Last Updated