A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

Running, not enrolling · Phase 1/Phase 2

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

In brief

The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.

Key facts

Study ID

NCT05589896

Run by

Ossium Health, Inc.

People needed

12

Starts

2024-08-16

Expected to finish

2029-05-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 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 ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D)
• Patient must require allogeneic HCT per the discretion of the treating physician
• 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
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosed with malignant hematologic disease including:
• Acute leukemia [acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning
• Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell 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
• 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 for hemoglobin.
• Hepatic: total bilirubin ≤2.0 mg/dL, and ALT, AST, and ALP <3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related
• Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl> 60 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR)

You may not qualify if…

• Availability of suitable graft from living donor (defined as 7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors)
• Prior autologous or allogeneic HCT
• Pregnancy or lactation
• Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug
• 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

Where it is running

• City of Hope — Duarte, California, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Henry Ford Cancer Institute — Detroit, Michigan, United States
• Oregon Health and Science University — Portland, Oregon, United States
• TriStar Bone Marrow Transplant — Nashville, Tennessee, United States
• St. David's South Austin Medical Center — Austin, Texas, United States
• Methodist Hospital, Texas Transplant — San Antonio, Texas, United States
• University of Utah - Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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