Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies

Starting soon · Not applicable

Conditions studied: Hematologic Malignancy, Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Acute Undifferentiated Leukemia, CLL (Chronic Lymphocytic Leukemia), Chronic Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Non Hodgkin Lymphoma, Hodgkin Lymphoma, Cutaneous T Cell Lymphomas (CTCL)

In brief

Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.

Key facts

Study ID: NCT07710781
Run by: Ossium Health, Inc.
People needed: 300
Starts: 2026-12-01
Expected to finish: 2031-03-31
Last updated by the study team: 2026-07-20

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements.
Male or female, aged ≥12 and ≤65 years for patients receiving MAC aged ≥12 and ≤75 years for patients receiving RIC. Patients between 75 and 80 years on RIC regimen can be enrolled with prior sponsor approval
Patient must require first allogeneic HCT per the discretion of the treating physician
BMI <=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval)
For treatment from Ossium product only- no suitable donor available after 3 weeks of search
Patient must be high-resolution:
HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product for experimental arm
HLA fully matched (8/8 allele matched at HLA-A, -B, -C, DRB1) to an unrelated available PBSC donor for observational standard of care arm
HLA partially matched (4-7/8 allele matched at HLA-A, -B, -C, DRB1) to an available PBSC donor for observational standard of care arm
HLA haploidentical matched (4/8 allele matched at HLA-A, -B, -C, DRB1) to available PBSC donor for observational standard of care arm
HLA partially matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available living bone marrow donor for optional observational standard of care arm
Stated willingness to comply with all study procedures and availability for the duration of the study
Patient with malignant hematologic disease including:
Diagnosed with acute leukemia [acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)], , in the first remission or beyond with ≤5% marrow blasts and no circulating blasts or extra-medullary disease documented by bone marrow assessment within 42 days prior to anticipated start of conditioning or
MDS without Grade 3 fibrosis (Patients with Grade 1 and Grade 2 fibrosis can be enrolled with prior sponsor approval)
Chronic Lymphocytic Leukemia (CLL) eligible for allogeneic transplant or
Chronic Myeloid leukemia (CML) eligible for allogeneic transplant
Chemosensitive lymphomas in the first remission or beyond documented by PET/CT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning
Other rare hematological malignancy indications eligible for allogenic transplant will require prior sponsor review and approval
Absence of active CNS disease due to underlying hematological disease
Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
HCT comorbidity index (HCT-CI) ≤5
Adequate organ function defined as:
Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)
Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected (dinakara correction) for hemoglobin.

You may not qualify if…

Autologous transplant within 6 months
Prior allogeneic HCT
Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded
HTLV-ATLL positive patients are excluded
Currently Pregnant or Currently lactating parent
Participation with an investigational trial within 3 months of planned transplant (Note: participation in survey studies or standard of care studies maybe allowed after sponsors approval or are part of long term follow up for an interventional trial)
Recipient of allogeneic CART-T therapy
Recipient of checkpoint inhibitor in last 3 months
Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings
Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
Presence of donor-specific antibodies. Recipient has positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by either:
positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or
presence of donor specific HLA antibodies (DSA) to any mismatched HAS allele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, -DPA1, -DPB1) with median fluoresce intensity (MFI) >3000 by Luminex single antigen bead based solid phase immunoassay tested prior to SSA request and repeated if transplant is >30 days from prior HLA antibody testing or if patient receives additional blood products/transfusion prior to transplant
Patients with donor specific HLA antibodies (DSA) to donor that is reduced post treatment of de-sensitization for DSA

Full record on ClinicalTrials.gov

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