A New Front Against a Deadly Transplant Complication: 'Off-the-Shelf' Cell Therapy Enters Clinical Trials

NEW YORK, NY – January 08, 2026 – By Jack Patterson

A new clinical trial is set to explore a novel cell therapy aimed at preventing one of the most feared and deadly complications of stem cell transplantation. MiNK Therapeutics (NASDAQ: INKT), a clinical-stage biotechnology firm, announced today it is partnering with the University of Wisconsin–Madison to launch a Phase 1 study of its lead therapy, agenT-797. The trial will investigate whether this “off-the-shelf” cell therapy can safely prevent Graft-Versus-Host Disease (GvHD) in patients with high-risk leukemias and other blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

The investigator-sponsored trial represents a significant step for a therapy that has already shown promise in treating solid tumors and severe respiratory inflammation. It expands the potential application of MiNK's unique cell therapy platform into the critical field of transplantation, where GvHD remains a major barrier to successful long-term outcomes.

The Devastating Challenge of Graft-Versus-Host Disease

For patients with aggressive blood cancers, an allo-HSCT—a transplant of stem cells from a healthy donor—can be a life-saving cure. But the procedure carries a profound risk: Graft-Versus-Host Disease. This condition occurs when the newly transplanted donor immune cells (the graft) recognize the patient’s body (the host) as foreign and launch a devastating attack on healthy tissues and organs. GvHD affects up to half of all transplant recipients and is a leading cause of severe illness and death following the procedure.

Clinicians divide GvHD into two forms: acute, which typically occurs within the first 100 days post-transplant, and chronic, which can develop later and persist for years. The effects can range from skin rashes and gastrointestinal distress to life-threatening damage to the liver, lungs, and other organs. The standard method for preventing GvHD involves suppressing the patient's immune system with powerful drugs like corticosteroids. While partially effective, this approach is a double-edged sword. It leaves vulnerable patients highly susceptible to serious infections and can blunt the beneficial “graft-versus-leukemia” effect, where the donor cells attack any remaining cancer cells, increasing the risk of relapse. Furthermore, the long-term use of steroids carries its own burden of debilitating side effects, highlighting a critical unmet need for safer, more effective preventative strategies.

A Novel 'Off-the-Shelf' Immunotherapy

AgenT-797 offers a fundamentally different approach. It is an allogeneic invariant natural killer T (allo-iNKT) cell therapy. These iNKT cells are a rare and powerful type of immune cell that acts as a “master regulator,” bridging the gap between the body's innate and adaptive immune systems. Unlike conventional T-cells that can cause GvHD, iNKT cells have demonstrated the ability to suppress harmful inflammatory responses while preserving, and even enhancing, anti-tumor activity.

Crucially, MiNK’s therapy is designed to overcome major logistical hurdles that limit other cell therapies. As an “off-the-shelf” product, agenT-797 is manufactured from healthy donors, cryopreserved, and stored for immediate use. This eliminates the lengthy and expensive process of creating a custom therapy for each patient. It is also designed to be administered without the need for human leukocyte antigen (HLA) matching, meaning a single product could potentially treat a wide range of patients. Perhaps most significantly for this fragile patient population, the therapy can be given without a preceding “lymphodepletion” regimen—the harsh chemotherapy used to wipe out a patient’s existing immune cells before other cell therapies are infused.

“This trial marks an important step in expanding our iNKT platform into GvHD, targeting one of the most serious and persistent complications of stem cell transplantation, where effective options remain limited,” said Jennifer Buell, PhD, President and Chief Executive Officer of MiNK Therapeutics. “Our objective is to reduce GvHD and relapse while supporting immune reconstitution, with the potential to improve survival and quality of life for transplant patients—without the cytotoxic burden of lymphodepleting conditioning regimens.”

The Power of Public-Private Partnership

Bringing such a cutting-edge therapy from the laboratory to the clinic is a monumental task, often prohibitively expensive for smaller biotech companies. This trial is made possible by a unique and powerful public-private funding model that combines federal and philanthropic support.

A Small Business Technology Transfer (STTR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, supports the foundational preclinical work between MiNK and the UW–Madison team. This non-dilutive funding validates the scientific premise while allowing the company to advance its research without diluting shareholder value—a critical factor for a micro-cap biotech firm navigating a competitive funding landscape.

Complementing the federal grant is the Mary Gooze Clinical Trial and Translation Award, a philanthropic grant from the University of Wisconsin Carbone Cancer Center's More for Stage IV fund. This award directly finances the Phase 1 trial’s operations, including patient enrollment and immune monitoring. It also supports deeper mechanistic research in the laboratory of Jenny Gumperz, PhD, Professor of Medical Microbiology & Immunology at UW, to better understand precisely how iNKT cells control leukemia.

“Our research has shown that iNKT cells can restore immune balance and promote healthy engraftment,” said Professor Gumperz. “This trial brings years of translational work full circle by enabling clinical evaluation of an innovative immune-regulating therapy for patients in need.”

A Strategic Step to Redefine Transplant Outcomes

The trial will be led by Principal Investigator Hongtao Liu, MD, PhD, an Associate Professor of Medicine at the University of Wisconsin School of Medicine and Public Health. His team will evaluate the safety, tolerability, and initial efficacy of agenT-797 in reducing GvHD, relapse, and other post-transplant complications.

“As a transplant physician, I see firsthand the toll GvHD takes on patients and families,” Dr. Liu stated. “This study is designed not only to reduce this life-threatening complication but also to enhance immune reconstitution and reduce relapse risk, with the potential to change post-transplant outcomes.”

For MiNK Therapeutics, this trial represents a key strategic diversification of its iNKT platform. With positive safety and activity data already generated from studies of agenT-797 in solid tumors and acute respiratory distress syndrome (ARDS), the move into GvHD showcases the therapy's potential versatility as an immune-regulating agent. Success in this area would not only open a significant new market but also further validate the broad applicability of the underlying technology.

While the journey through clinical trials is long and the outcome uncertain, the initiation of this study offers a tangible sense of progress. For thousands of patients who undergo stem cell transplantation each year, the prospect of a therapy that could prevent GvHD without compromising their ability to fight infection or cancer represents a profound new source of hope.