Acute Leukemia, Acute Lymphoid Leukemia, Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Chronic Myeloid Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
hematopoietic stem cell transplantation, acute leukemia, Myelodysplastic syndromes, matched related donor, matched unrelated donor, TREGZI
Brief summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.
Interventions
BIOLOGICALOrca-T
an allogeneic stem cell and T-cell immunotherapy biologic
Sponsors
Orca Biosystems, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Recipients must meet all of the following criteria: 1. Patients must be diagnosed with 1 of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned: A) Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia who are not in CR or CRi (active disease) and/or MDS with \>10% to \<20% bone marrow blast burden (ages 18 to 75 years) B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years) C) BPDCN (ages 18 to 65 years) D) Participants aged 18 to 65 who would be eligible for the Phase 3 component of Precision-T except for mild impairments of renal and/or hepatic function as defined by an eGFR of 50 to \<60 mL/min and/or a total bilirubin of \>ULN to ≤2 x ULN and diagnosed with either of the following: i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk a) MDS that is DRI intermediate to high risk E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following: i. CML in chronic phase but with a history of accelerated phase or blast crisis or who are resistant to or intolerant of more than 1 first- and second-generation tyrosine kinase inhibitors ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of primary graft failure | 365 days | The incidence of primary graft failure |
| The incidence of grade 3 or 4 aGVHD | 180 days | The incidence of grade 3 or 4 aGVHD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year overall survival (OS) | 365 days | 1-year overall survival (OS) |
| 1 year graft-versus-host-disease-free and relapse-free survival (GRFS) | 365 days | 1 year graft-versus-host-disease-free and relapse-free survival (GRFS) |
| incidence and severity of acute and chronic graft vs host disease (GvHD) | 365 days | incidence and severity of acute and chronic graft vs host disease (GvHD) |
| incidence of serious infections | 365 days | incidence of serious infections |
| incidence of engraftment | 28 days | incidence of engraftment of platelets and neutrophils |
Countries
United States
Outcome results
None listed