Status:

RECRUITING

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

Lead Sponsor:

Ossium Health, Inc.

Conditions:

Acute Leukemia

Acute Lymphoblastic Leukemia

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

PHASE2

Brief Summary

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, myelodyspl...

Eligibility Criteria

Inclusion Criteria:

  • 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:

    1. 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
    2. 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:

    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 for hemoglobin.
    3. 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
    4. 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)

Exclusion Criteria:

  • 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

Key Trial Info

Start Date :

August 16 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 31 2027

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT05589896

Start Date

August 16 2024

End Date

March 31 2027

Last Update

February 24 2026

Active Locations (9)

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Page 1 of 3 (9 locations)

1

City of Hope

Duarte, California, United States, 91010

2

Moffitt Cancer Center

Tampa, Florida, United States, 33612

3

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States, 30322

4

Henry Ford Cancer Institute

Detroit, Michigan, United States, 48202