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NCT05589896

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

Active, Not Recruiting
PHASE1Ages 18–75InterventionalTreatment
Ossium Health, Inc.
~12 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Ossium HPC Marrow, Bone Marrow TransplantPre-transplant conditioning - Myeloablative (MAC)Pre-transplant conditioning - Reduced Intensity (RIC)Post-transplant treatment

At a glance

Recruiting sites
0 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neutrophil Engraftment
Measured over Day 28
+4 more outcomes measured

Conditions

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)

Explore related trials

Acute Biphenotypic LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Undifferentiated LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveHematologic NeoplasmHodgkin's GranulomaMyelodysplastic SyndromeNon-Hodgkin LymphomaPrimary Cutaneous T-Cell Non-Hodgkin LymphomaHLA Complex

Where it's being run

9 sites across 8 states
Texas2
California1
Florida1
Georgia1
Michigan1
Oregon1
Tennessee1
Utah1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
HCT comorbidity index (HCT-CI) ≤5
Adequate organ function defined as:

Exclusion

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

What this trial measures

  • Neutrophil EngraftmentDay 28

    Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on 3 different days by Day 28.

  • Serious Adverse EventsDay 56

    Occurrence of any event classified as SAE. The time of occurrence of each serious adverse event will be recorded.

  • CTCAE Grade 3/4 Adverse Events (AEs)Day 56

    Occurrence of any event classified as grade 3/4 AE attributed to Ossium HPC, Marrow per the CTCAE v5.0 guidelines. The time of the occurrence of each event will be recorded.

  • CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, MarrowDay 28

    Occurrence of any event classified as grade 3 or higher attributed to Ossium HPC, Marrow infusion per the CTCAE v5.0 guidelines. The time of the occurrence will be recorded.

  • DeathDay 56

    The time of death will be recorded for each expired patient.