At GentiBio, our mission is to develop innovative and safe Treg cell therapies to transform the lives of patients with autoimmune and inflammatory diseases. We are currently evaluating our investigational product, GNTI-122, in early-stage clinical trials to assess its safety, tolerability, and efficacy.
What is Expanded Access?
Expanded access—also known as compassionate use—is a potential pathway for patients with serious or life-threatening conditions to gain access to investigational therapies outside of a clinical trial, when no comparable or satisfactory alternative therapy options are available. These programs are subject to regulatory oversight and require certain criteria to be met to ensure patient safety and appropriate use of the investigational product.
GentiBio’s Position on Expanded Access
We understand that patients and families facing serious or life-threatening conditions may seek access to investigational therapies outside of clinical trials. At this time, GentiBio is not offering an expanded access program for GNTI-122.
We believe that the most efficient and scientifically rigorous way to assess the potential of GNTI-122 is through well-controlled studies designed to generate the data required for regulatory review and potential future approval.
Clinical Trial Participation
We encourage patients and healthcare providers interested in GNTI-122 to consider participation in our clinical trials. Information about our ongoing studies can be found at www.clinicaltrials.gov by searching for “GNTI-122”.
Future Updates
GentiBio will continue to evaluate our access policies as our development programs progress. If our position on expanded access changes in the future, we will provide updates on this page.
For further inquiries, please contact us at EA@gentibio.com.