MGTA-456 for High-Risk Cancer

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: HIV, Active infection, Prior transplant, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

This is an single arm, open label, interventional phase II trial evaluating the efficacy of umbilical cord blood (UCB) hematopoietic stem and progenitor cells (HSPC) expanded in culture with stimulatory cytokines (SCF, Flt-3L, IL-6 and thromopoietin) on lympho-hematopoietic recovery. Patients will receive a uniform myeloablative conditioning and post-transplant immunoprophylaxis.

Eligibility Criteria

This trial is for patients under 55 years old, weighing over 11 kg, with high-risk malignancies like various leukemias and lymphomas. They must have a partially matched umbilical cord blood unit for transplant and meet specific health criteria including good organ function and performance status. Pregnant women, those with HIV or other active cancers/infections, or previous transplants are excluded.

Inclusion Criteria

I weigh more than 11 kilograms.

I am 55 years old or younger.

I have a specific type of leukemia or lymphoma that is in a particular stage or condition.

Exclusion Criteria

I have another active cancer besides the one being treated.

I am over 23 and can't have a specific radiation due to past intense treatments.

You have been diagnosed with HIV or have HIV antibodies in your blood.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning

Participants receive a uniform myeloablative conditioning regimen

1-2 weeks

Treatment

Participants receive MGTA-456 infusion and post-transplant immunoprophylaxis

14 days

Daily visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• MGTA-456 Infusion

Trial Overview The trial tests the effectiveness of expanded umbilical cord blood stem cells combined with a uniform myeloablative conditioning regimen (using drugs like Melphalan) and post-transplant immunoprophylaxis to improve recovery in patients with high-risk malignancies.

Participant Groups

Group I: FLU, CY, TBI + MGTA-456 infusion Experimental Treatment 9 Interventions

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+