GVHD Clinical Trial
Official title:
Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
This is a randomized, single-center phase 1/2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.
This randomized, single-center phase 1/2a clinical trial, conducted without blinding, aims to explore the therapeutic promise of regulatory T cells (Tregs). Tregs are specialized immune cells that play a crucial role in modulating the body's immune response, thus offering a unique therapeutic avenue for immune-related conditions. They have already demonstrated significant potential in managing a spectrum of diseases, including autoimmune disorders such as multiple sclerosis and type 1 diabetes, inflammatory conditions like inflammatory bowel disease, and transplant rejection, which is commonly encountered in organ and stem cell transplants. The trial's primary focus is on graft-versus-host disease (GVHD), a severe complication that can occur after allogeneic hematopoietic stem cell transplantation (HSCT). GVHD emerges when the donated immune cells attack the recipient's tissues, leading to symptoms ranging from mild to life-threatening. Currently, GVHD treatment relies on broad immunosuppressive therapies, which often come with significant side effects and may not always be effective. By recruiting participants for this clinical trial, we aim to assess the safety and efficacy of Tregs in mitigating the immune system's attack on the recipient's body. Autologous Tregs offer a more targeted approach due to their ability to distinguish between harmful and beneficial immune responses, potentially reducing the need for broad immunosuppression. The trial's structure includes dose-escalation and dose-expansion phases to evaluate optimal dosages, assess any adverse reactions, and measure the therapeutic benefits in GVHD management. Through this systematic and thorough evaluation, the investigators hope to refine Treg therapy and establish a clear safety profile. Ultimately, this trial seeks to unlock the therapeutic potential of autologous Tregs, paving the way for future applications in a broader range of conditions. ;
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