MGTA-456 for High-Risk Cancer

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Masonic Cancer Center, University of Minnesota

No Placebo Group

Prior Safety Data

Trial Summary

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 partially matched cord blood unit for my transplant.

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.

I have a donor who matches my HLA type for a stem cell transplant.

I have had a stem cell transplant from myself or a donor.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: FLU, CY, TBI + MGTA-456 infusionExperimental Treatment9 Interventions