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

July 13, 2026 updated by: Ossium Health, Inc.

A Multicenter, Open Label Study to Evaluate the Efficacy, Tolerability, and Safety of Partially to Fully HLA-Matched Allogeneic Cryopreserved Deceased-Donor Bone Marrow Transplantation and Living Donor Transplantation in Patients With Hematologic Malignancies

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a 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. The study will have block enrollment at each site (block size 3 patients). Patients will be enrolled in the following treatment arms for each block:

Experimental Arm:

Arm 1: Ossium HPC, marrow (n=100)

Observational arms:

Arm 2: Living mismatched unrelated PBSC donor (n=100) Arm 3: Living Haplo related PBSC donor (n=100)

The observational arm is standard of care arm. No prospective intervention will be specified, the data will be collected as per T&E schedule. One hundred patients will be enrolled into each arm.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements.
  2. 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
  3. Patient must require first allogeneic HCT per the discretion of the treating physician
  4. BMI <=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval)
  5. For treatment from Ossium product only- no suitable donor available after 3 weeks of search

  6. Patient must be high-resolution:

    1. 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
    2. 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
    3. 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
    4. HLA haploidentical matched (4/8 allele matched at HLA-A, -B, -C, DRB1) to available PBSC donor for observational standard of care arm
    5. 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
  7. Stated willingness to comply with all study procedures and availability for the duration of the study

  8. Patient with malignant hematologic disease including:

    1. 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
    2. MDS without Grade 3 fibrosis (Patients with Grade 1 and Grade 2 fibrosis can be enrolled with prior sponsor approval)
    3. Chronic Lymphocytic Leukemia (CLL) eligible for allogeneic transplant or
    4. Chronic Myeloid leukemia (CML) eligible for allogeneic transplant
    5. 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
    6. Other rare hematological malignancy indications eligible for allogenic transplant will require prior sponsor review and approval
    7. Absence of active CNS disease due to underlying hematological disease
  9. Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
  10. HCT comorbidity index (HCT-CI) ≤5

  11. Adequate organ function defined as:

    1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)
    2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected (dinakara correction) for hemoglobin.
    3. Hepatic: total bilirubin ≤2.0 mg/dL (except Gilbert syndrome ), and ALT, AST, and ALP <3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related
    4. Renal: CrCl> 45 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)) or Cystatin-C test.

Exclusion Criteria:

  1. Autologous transplant within 6 months
  2. Prior allogeneic HCT
  3. Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded
  4. HTLV-ATLL positive patients are excluded
  5. Currently Pregnant or Currently lactating parent
  6. 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)
  7. Recipient of allogeneic CART-T therapy
  8. Recipient of checkpoint inhibitor in last 3 months
  9. Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings
  10. Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation

  11. Presence of donor-specific antibodies. Recipient has positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by either:

    1. positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or
    2. 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
    3. Patients with donor specific HLA antibodies (DSA) to donor that is reduced post treatment of de-sensitization for DSA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ossium HPC, Marrow Donor
Other: Ossium HPC, Marrow
Cryopreserved deceased donor bone marrow
Other: Haplo Related PBSC Donor
Standard of care living donor - Haplo Related PBSC Donor
Other: Standard of care living donor - Haplo Related
Haplo Related PBSC donor
Other: Mismatched unrelated PBSC Donor
Standard of care living donor - Mismatch Unrelated PBSC Donor
Other: Standard of care living donor - Mismatched Unrelated
Mismatched Unrelated PBSC donor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine cumulative neutrophil engraftment
Time Frame: Day 30
Characterize cumulative neutrophil engraftment in Ossium HPC, Marrow arm
Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ossium Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2031

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRESERVE II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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