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Phase 1, Phase 2RecruitingPriority 2 · High priorityNCT05589896

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

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is studying Ossium HPC Marrow, Bone Marrow Transplant, and other medications for people with cutaneous T-cell lymphoma (skin lymphoma). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 9 US locations across multiple states.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Must be well enough for treatment (adequate performance status)

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

Ossium HPC Marrow, Bone Marrow Transplant (OTHER): Hematopoetic Cell Transplantation | Pre-transplant conditioning - Myeloablative (MAC) (OTHER): Regimen A or Regimen B | Pre-transplant conditioning - Reduced Intensity (RIC) (OTHER): Regimen C or Regimen D | Post-transplant treatment (OTHER): Post-transplant treatment

Drugs / treatments
Ossium HPC Marrow, Bone Marrow Transplant, Pre-transplant conditioning - Myeloablative (MAC), Pre-transplant conditioning - Reduced Intensity (RIC), Post-transplant treatment
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1, Phase 2
Status
Recruiting
Design
Non-randomized, open-label
Enrollment target
12 patients
Primary endpoint
Neutrophil Engraftment; Serious Adverse Events; CTCAE Grade 3/4 Adverse Events (AEs); CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow; Death
Ages
18 Years to 75 Years
Start date
2024-08-16
Est. completion
2027-03-31

Locations

9 US sites · 9 total

CaliforniaFloridaGeorgiaMichiganOregonTennesseeTexasUtah

Contact

Sponsor
Ossium Health, Inc. (INDUSTRY)
Contact
Preethi Prasad, M.Sc. | preethi.prasad@ossiumhealth.com | 628-842-6562

Tags

CTCLany
TrialCompass — Clinical Trial Summary

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

NCT05589896

Phase: Phase 1, Phase 2 | Status: Recruiting | Priority: High

Plain-language summary

This Phase 1, Phase 2 trial is studying Ossium HPC Marrow, Bone Marrow Transplant, and other medications for people with cutaneous T-cell lymphoma (skin lymphoma). Patients are randomly assigned to different treatment groups to see which approach works best. It is available at 9 US locations across multiple states.

Who can join

  • Age 18 Years to 75 Years years
  • Must be well enough for treatment (adequate performance status)

What's being tested

Ossium HPC Marrow, Bone Marrow Transplant (OTHER): Hematopoetic Cell Transplantation | Pre-transplant conditioning - Myeloablative (MAC) (OTHER): Regimen A or Regimen B | Pre-transplant conditioning - Reduced Intensity (RIC) (OTHER): Regimen C or Regimen D | Post-transplant treatment (OTHER): Post-transplant treatment

Drugs / treatments: Ossium HPC Marrow, Bone Marrow Transplant, Pre-transplant conditioning - Myeloablative (MAC), Pre-transplant conditioning - Reduced Intensity (RIC), Post-transplant treatment

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 12 patients

Primary endpoint: Neutrophil Engraftment; Serious Adverse Events; CTCAE Grade 3/4 Adverse Events (AEs); CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow; Death

Ages: 18 Years to 75 Years

Start date: 2024-08-16 | Est. completion: 2027-03-31

Locations

9 US sites · 9 total

California, Florida, Georgia, Michigan, Oregon, Tennessee, Texas, Utah

Contact

Preethi Prasad, M.Sc. | preethi.prasad@ossiumhealth.com | 628-842-6562

Sponsor: Ossium Health, Inc. (INDUSTRY)

Tags

CTCL · any

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT05589896

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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