MiNK Therapeutics Launches Phase 1 Trial of agenT-797 for Graft-Versus-Host Disease Prevention
核心洞察
MiNK Therapeutics announced the initiation of a Phase 1 clinical trial evaluating agenT-797, an off-the-shelf allogeneic iNKT cell therapy, in patients undergoing stem cell transplantation to prevent graft-versus-host disease (搜索).
The investigator-sponsored trial will assess safety, tolerability, and preliminary efficacy of agenT-797 in reducing GvHD (搜索), relapse, and post-transplant complications in patients with high-risk leukemias and blood cancers.
The therapy represents a novel approach that requires no lymphodepletion or HLA matching, potentially offering improved outcomes for transplant patients while addressing a complication affecting up to half of stem cell transplant recipients.
MiNK Therapeutics announced the upcoming initiation of a Phase 1, investigator-sponsored clinical trial evaluating its lead therapy, agenT-797, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). The trial represents a significant expansion of the company's invariant natural killer T (iNKT) cell platform into transplantation medicine, targeting graft-versus-host disease (搜索) (GvHD (搜索)), one of the most serious complications following stem cell transplantation.
Trial Design and Leadership
The Phase 1 study will be led by Hongtao Liu, MD, PhD, Associate Professor of Medicine at the University of Wisconsin School of Medicine and Public Health, with co-investigator Kalyan V. G. Nadiminti, MD, Assistant Professor of Medicine at the same institution. The trial will evaluate the safety, tolerability, and preliminary efficacy of agenT-797 in reducing GvHD (搜索), relapse, and other post-transplant complications in patients with high-risk leukemias and other blood cancers.
"As a transplant physician, I see firsthand the toll GvHD (搜索) takes on patients and families," said Dr. Liu, the study's Principal Investigator. "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."
Addressing a Critical Medical Need
GvHD (搜索) represents a leading cause of morbidity and mortality following HSCT, affecting up to half of recipients. The condition occurs when donor immune cells attack the recipient's tissues, creating a significant clinical challenge in transplant medicine. Current treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches.
"This trial marks an important step in expanding our iNKT platform into GvHD (搜索), 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."
Unique Therapeutic Approach
agenT-797 is an off-the-shelf, donor-derived iNKT cell therapy that offers several distinctive advantages. The therapy requires no lymphodepletion or human leukocyte antigen (HLA) matching, potentially simplifying treatment protocols and reducing patient burden. iNKT cells (搜索) are uniquely positioned for this application, as they can suppress inflammatory allo-immune responses while preserving anti-leukemia (搜索) activity and immune competence.
The therapy has previously demonstrated favorable safety and immune-modulating activity in solid tumors and acute respiratory distress syndrome (搜索) (ARDS (搜索)). agenT-797 functions as what researchers describe as "master regulators," combining the cytotoxic capabilities of NK cells with T-cell-like antigen recognition and memory.
Funding and Collaborative Support
The trial benefits from two complementary public-private funding awards that support comprehensive development of agenT-797 in HSCT and GvHD (搜索) applications. An NIH STTR grant from the National Institute of Allergy and Infectious Diseases (NIAID (搜索)) supports MiNK and the University of Wisconsin–Madison team in developing and evaluating agenT-797 in preclinical models. Additionally, the Mary Gooze Clinical Trial Award to the University of Wisconsin–Madison directly funds enrollment, immune monitoring, and operations for the Phase 1 trial.
The collaborative team also includes Jenny Gumperz, PhD, Professor of Medical Microbiology & Immunology at the University of Wisconsin School of Medicine and Public Health. Beyond clinical testing, the award supports mechanistic research in the Gumperz laboratory to define how iNKT cells (搜索) control leukemia (搜索).
"Our research has shown that iNKT cells (搜索) 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."
Platform Technology and Manufacturing
agenT-797 represents MiNK's proprietary platform designed to restore immune balance and drive cytotoxic responses across cancer, immune-mediated diseases, and pulmonary immune failure. The therapy is manufactured in Lexington, Massachusetts, using a scalable cryopreserved manufacturing process that enables off-the-shelf availability.
In clinical trials, agenT-797 has demonstrated the ability to bolster peripheral memory T-cell activation, enhance tumor infiltration, and potentially improve outcomes for patients with solid cancers, as well as combat inflammation in critically ill patients with severe respiratory pathology.
The work complements an ongoing collaboration between the University of Wisconsin–Madison and MiNK under an NIAID (搜索)-funded STTR grant, aimed at developing a universal, donor-independent iNKT platform for hematologic malignancies. This comprehensive approach enables simultaneous execution of translational and clinical studies of iNKTs in GvHD (搜索) prevention.