Omidubicel for Blood Cancers

Recruiting at 5 trial locations

Overseen By Kelly Myers

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Gamida Cell ltd

Disqualifiers: Bone marrow fibrosis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

Trial Summary

What is the purpose of this trial?

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Research Team

Mitchell Horwitz, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for patients aged 12 or older with high-risk blood cancers who have at least one partially HLA-matched cord blood unit available. They must be physically able to undergo a transplant and not pregnant. A backup stem cell source is required, and women of childbearing age must agree to use contraception.

Inclusion Criteria

I am at least 12 years old.

I have a backup source for stem cells.

My body is strong enough to handle treatment.

Exclusion Criteria

My bone marrow is significantly scarred.

I am not a candidate for organ transplant due to my health.

I have antibodies against donor tissues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an infusion of omidubicel, a stem/progenitor cell-based product, for transplantation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after transplantation

12 weeks

Open-label extension

Participants may continue to be monitored for long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Omidubicel

Trial Overview The trial is testing omidubicel, an experimental therapy designed to improve outcomes in allogeneic transplantation for individuals with serious hematologic malignancies (blood cancers).

Participant Groups

Group I: omidubicel Experimental Treatment 1 Intervention

Omidubicel is a cryopreserved stem/progenitor cell based product comprised of: 1. Ex vivo expanded, umbilical cord blood-derived hematopoietic CD34+ progenitor cells (cultured fraction (CF)) 2. the non-cultured cell fraction of the same Cord Blood Unit (CBU) (Non-cultured Fraction (NF)) consisting of mature myeloid and lymphoid cells. Both fractions, i.e. CF and NF, will be kept frozen until they are thawed and infused on the day of transplantation.

Who Is Running the Clinical Trial?

Gamida Cell ltd

Lead Sponsor

Trials

9

Recruited

290+