agenT-797 for Stem Cell Transplantation

HL
Overseen ByHongtau Liu, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

HL

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

I have acute lymphoblastic leukemia with high-risk features or it has come back.
I am an adult scheduled for a donor stem cell transplant.
All donor types are accepted (MMUD mismatched unrelated donor, MUD matched unrelated donor, MSD matched sibling donor, haploidentical)
See 7 more

Exclusion Criteria

I do not have primary myelofibrosis if joining the dose escalation phase.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an infusion of agenT-797 about 7 days after their allogenic SCT, with dose escalation every 2 weeks

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and donor chimerism

4 weeks
2 visits (in-person)

Long-term Follow-up

Participants are monitored for progression-free survival, overall survival, and other secondary outcomes

12 months

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

Group I: Allogeneic iNKT CellsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

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 ...

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 ...

6.

investor.minktherapeutics.com

investor.minktherapeutics.com/node/7311/pdf

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- ...