agenT-797 for Stem Cell Transplantation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called agenT-797 to determine its safety for individuals who have undergone a stem cell transplant. The primary goal is to identify any side effects or medical issues that might result from taking agenT-797. Participants will receive this treatment approximately one week after their transplant. It suits adults undergoing a stem cell transplant for certain blood cancers, such as acute myeloid leukemia or myelodysplastic syndrome, using a donor. As a Phase 1 trial, the research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that agenT-797 is safe for people undergoing stem cell transplantation?
Research has shown that agenT-797, a type of cell therapy, was safe in earlier studies. Most patients did not experience serious side effects. Notably, no cases of severe immune reactions or donor cells attacking the patient's body occurred. This suggests that agenT-797 could be a safe option for individuals undergoing stem cell transplants.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for stem cell transplantation, which often involves conventional chemotherapy or radiation to prepare patients for a transplant, agenT-797 is unique because it uses allogeneic invariant natural killer T (iNKT) cells. These iNKT cells are a type of immune cell that can be administered through intravenous infusion, potentially offering a novel way to enhance the body's immune response against cancer cells. Researchers are excited about agenT-797 because it represents a new mechanism of action, targeting cancer cells more directly and possibly with fewer side effects compared to traditional treatments. This approach could lead to better outcomes for patients undergoing stem cell transplantation.
What evidence suggests that agenT-797 might be an effective treatment for stem cell transplantation?
Studies have shown that agenT-797, a type of cell therapy, may help strengthen the immune system. Research suggests it can combat harmful germs and activate the body's defenses. Other trials have found it well-tolerated, indicating safety so far. In patients with various conditions, agenT-797 has shown potential in reducing cancer cells and improving immune health. These early findings offer hope for its benefits in people receiving stem cell transplants. Participants in this trial will receive agenT-797 through a 3+3 dose escalation, administered by intravenous infusion every 2 weeks.678910
Who Is on the Research Team?
Hongtau Liu, MD, PhD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
This trial is for people with blood cancers like leukemia, lymphoma, or myelodysplastic syndrome who have recently had a donor stem cell transplant. Participants must be healthy enough after their transplant to receive an additional treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an infusion of agenT-797 about 7 days after their allogenic SCT, with dose escalation every 2 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and donor chimerism
Long-term Follow-up
Participants are monitored for progression-free survival, overall survival, and other secondary outcomes
What Are the Treatments Tested in This Trial?
Interventions
- agenT-797
Trial Overview
The study is testing the safety of agenT-797, a new type of immune cell therapy given by infusion about one week after a donor stem cell transplant. Researchers will monitor participants closely for any health problems.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Citations
NCT04754100 | agenT-797 in Participants With Relapsed/ ...
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell ...
MiNK Therapeutics Reports New Data on agenT-797 ...
agenT-797 demonstrates pathogen suppression, lung immune restoration and tissue repair activation, supporting Ongoing Phase 2
(PDF) 1344 AgenT-797, an allogeneic iNKT cell therapy ...
AgenT-797 was well tolerated as monotherapy. Results support the 3 (Rectal) and >50% reduction of tumor cells in bone marrow with SD>10 ( ...
A phase 1/2 clinical trial of invariant natural killer T cell ...
Here we show that agenT-797 rescues exhausted T cells and rapidly activates both innate and adaptive immunity. In 21 ventilated patients ...
MiNK Therapeutics and University of Wisconsin–Madison ...
agenT-797, an off-the-shelf, donor-derived iNKT cell therapy, has demonstrated favorable safety and immune-modulating activity in solid tumors ...
MiNK Presents Clinical Data on Allogeneic iNKT Cells ( ...
Clinical results showed pronounced survival benefit and manageable safety profile including: Patients on VV ECMO treated with agenT-797 had ...
AgenT-797 - Drug Targets, Indications, Patents
Cellular therapy using off-the-shelf iNKT cells is safe, can be rapidly scaled and is associated with an anti-inflammatory response.
MiNK Therapeutics (NASDAQ - INKT
How safe is MiNK Therapeutics' agenT-797 treatment? The treatment was well-tolerated with no cytokine release syndrome (CRS) or graft-versus- ...
MiNK Therapeutics Reports Durable Responses and ...
Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus- ...
(PDF) 1344 AgenT-797, an allogeneic iNKT cell therapy ...
AgenT-797 was well tolerated as monotherapy and in combo with PD-1 (pembro or nivo). Updated data on safety, efficacy, and translational ...
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