36 Participants Needed

Omidubicel for Blood Cancers

Recruiting at 5 trial locations
KM
Overseen ByKelly Myers
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Gamida Cell ltd
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

MH

Mitchell Horwitz, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.
See 4 more

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: omidubicelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gamida Cell ltd

Lead Sponsor

Trials
9
Recruited
290+
Unbiased ResultsWe believe in providing patients with all the options.
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