MGTA-456 for High-Risk Cancer
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.12345
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.12356
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Participants receive a uniform myeloablative conditioning regimen
Treatment
Participants receive MGTA-456 infusion and post-transplant immunoprophylaxis
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Masonic Cancer Center, University of Minnesota
Lead Sponsor
Citations
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, ...
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 ...
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.
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 [ ...
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 ...
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 ...
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