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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MGTA-456, which uses special stem cells from umbilical cord blood to help restore blood cell levels after cancer treatment. It targets individuals with high-risk blood cancers, such as certain types of leukemia and lymphoma, who are in remission but require additional support to prevent recurrence. Participants must have a specific type of blood cancer in remission and meet certain health criteria, including good organ function. The trial aims to determine if MGTA-456 can enhance recovery and outcomes for these patients. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that MGTA-456 infusion is likely to be safe for humans?

Research has shown that MGTA-456, a treatment using specially grown cells from umbilical cord blood, holds promise. In a study with 18 patients with high-risk blood cancers, MGTA-456 was used alone. Only a few serious side effects were reported, linked to the treatment. However, early results suggest that this method is generally safe and practical. It seems to help the body restore blood counts and immune function after treatment. Overall, MGTA-456 appears well-tolerated based on current research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard chemotherapy and radiation treatments for high-risk cancer, MGTA-456 is a unique therapy that uses an advanced cell infusion process. Researchers are excited about MGTA-456 because it involves a special type of stem cell infusion that could potentially improve engraftment and speed up recovery times for patients. This treatment aims to enhance the body's ability to restore healthy blood cells and immune function more effectively than traditional methods. By targeting the root of the problem at the cellular level, MGTA-456 offers a promising new approach that could lead to better outcomes for patients with high-risk cancer.

What evidence suggests that MGTA-456 infusion might be an effective treatment for high-risk cancer?

Research has shown that MGTA-456, which uses special cells from umbilical cord blood, may improve recovery after a transplant for high-risk cancers. In this trial, participants will receive an infusion of MGTA-456 following a regimen of FLU, CY, and TBI. Studies have found that patients who received MGTA-456 had a lower risk of death compared to those who did not receive this treatment. Additionally, MGTA-456 demonstrated quick and lasting improvements in disease outcomes, especially in severe cases. The treatment works by expanding these special cells in the lab to enhance the body's recovery after treatment. These early findings suggest that MGTA-456 could be a valuable option for patients with certain aggressive cancers. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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 am 55 years old or younger.

I weigh more than 11 kilograms.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT03674411/ICF_001.pdf

Key Information About This Research Study The purpose of this study is to increase the number of patients treated with MGTA-456 and further study the recovery of the blood counts and immune system, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11287950/

Umbilical cord blood derived cell expansion - PubMed Central Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy, Masonic Cancer Center, University of Minnesota, USA, Open label single arm, Leukemias ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT03674411/Prot_SAP_000.pdf

SINGLE-ARM, OPEN LABEL, INTERVENTIONAL PHASE II ... SINGLE-ARM, OPEN LABEL, INTERVENTIONAL PHASE II CLINICAL TRIAL. EVALUATING MGTA-456 IN PATIENTS WITH HIGH-RISK MALIGNANCY. CPRC 2018LS051.

4. stemcellres.biomedcentral.com stemcellres.biomedcentral.com/articles/10.1186/s13287-024-03830-0

Umbilical cord blood derived cell expansion: a potential ... Meta analyses of these studies also revealed a significant decrease in the risk of death following expanded UCB infusion, compared to controls [ ...

5. fda.gov fda.gov/media/181788/download

university of minnesota health sciences cv updated "A Phase 2 Trial Of Mgta-456 Cell Therapy. Demonstrates Rapid And Durable Long-Term Improvement In Disease Outcomes In Inherited. Metabolic ...

6. investor.dianthustx.com investor.dianthustx.com/static-files/c20e85d1-0384-48da-b411-d30c6308828d

Magenta Therapeutics, Inc. For example, we have observed a limited number of serious adverse events in the Phase 2 clinical trial of MGTA-456 in blood cancers that were considered to be ...