U.S. Expanded Access Policy

CARsgen Therapeutics is a clinical-stage immuno-oncology company committed to the development of First-in-Class and Best-in-Class CAR-T therapeutics. We understand the urgency of bringing these innovative immunotherapy products to patients and our commitment drives our work each day. 

 

Clinical trials are designed and conducted to determine the safety and efficacy of new investigational products in specific populations. Expanded access (also known as “compassionate use” or “early access”) refers to the use of an investigational new therapy outside of a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. Per U.S. FDA guidelines, expanded access programs must not interfere with ongoing or planned clinical trials which are designed to drive approval of a product and allow access to all appropriate patients. 

 

CARsgen Therapeutics is working to demonstrate the safety and effectiveness of several immuno-oncology products. We are conducting thoughtfully designed and robust clinical trial programs in order to obtain the global regulatory approvals needed to make these therapies widely available to the patients that need them around the world. We are currently unable to offer expanded access to our immuno-oncology therapies and we believe that participation in one of our clinical trials is the best way for patients to access our investigational therapies. 

 

More Information 

 

Treating physicians, patients and/or caregivers interested in learning more about CARsgen’s investigational CAR T cell therapies currently undergoing clinical studies can find more information by conducting an advanced sponsor search of CARsgen at https://clinicaltrials.gov/