Indapta’s Expanded Access Policy (EAP) covers the use of its investigational products outside of an ongoing clinical trial. Indapta appreciates the need for additional treatments for patients who have serious or immediately life-threatening diseases and have limited available treatment options. The decision to establish an EAP is dependent on a number of key factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies’ requirements. These include, but are not limited, to the following: 

• The illness for which the investigational cell therapy is being considered must be serious or life-threating, with no other satisfactory treatment options (such as approved products or enrolling clinical trials); 

• There is sufficient evidence that the potential benefit of the investigational drug to the patient would outweigh the potential risks, based on all available safety and efficacy information; and 

• Providing the investigational cellular immunotherapy as part of an EAP will not interfere with the enrollment of clinical trials to support the development and marketing approval. Based on these factors and the early stage of clinical development for our products, Indapta believes that participation in our clinical trials is the appropriate means to access our investigational cellular immunotherapies. 

Therefore, Indapta does not currently have an expanded access program. If you are a patient seeking access to our investigational product(s), please contact your treating healthcare provider. 

For more information about our ongoing clinical trials, please refer to www.clinicaltrials.gov, study number NCT06119685. Healthcare providers who are interested in learning more about clinical program(s) and investigational product(s) and/or participation in our clinical trial(s), please contact trials@indapta.com.