Health Trials

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

ConditionsAcute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAcute Biphenotypic LeukemiaAcute Undifferentiated LeukemiaCLL (Chronic Lymphocytic Leukemia)Chronic Myeloid Leukemia (CML)MDS (Myelodysplastic Syndrome)Non-Hodgkin LymphomasHodgkins LymphomaCutaneous T Cell Lymphomas (CTCL)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOssium Health, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ossium HPC Marrow, Bone Marrow Transplant
  • Pre-transplant conditioning - Myeloablative (MAC)
  • Pre-transplant conditioning - Reduced Intensity (RIC)
  • Post-transplant treatment

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ossium Health, Inc.

Lead sponsor

Source ClinicalTrials.gov