Talaris Therapeutics has commenced its Phase II FREEDOM-2 clinical trial of investigational allogeneic cell therapy, FCR001, in delayed tolerance induction.
This single-arm, multicentre, open-label trial will assess the safety and efficacy of the company’s cell therapy to induce durable immune tolerance in subjects who have received a kidney transplant from a living donor.
This process is known as delayed tolerance induction.
FCR001 is developed to induce or restore immune tolerance in immune-mediated or blood disorder patients who receive organ transplantation.
The US Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation to the therapy.
Talaris Therapeutics chief medical officer Nancy Krieger said: “This trial exploring the efficacy of FCR001 in the delayed tolerance setting is an important step toward potentially offering an alternative to long-term immunosuppression as the standard of care for organ transplant recipients today.
“We believe that this innovative approach could allow us to broaden the opportunity to apply this novel therapy in larger patient populations by expanding the options for previously transplanted patients whose donor is still available.”
In the clinical trial, the patients will be given FCR001 once with non-myeloablative conditioning and followed for five years. A primary analysis of the patients will be performed at 24 months.
The company selected Northwestern University as the first clinical site and the screening for eligible patients has started.
Additional sites for the FREEDOM-2 clinical trial are also anticipated to be activated next year.
Northwestern University Feinberg School of Medicine Fowler McCormick professor of surgery Joseph Leventhal said: “As a physician, I believe the possibility of inducing immune tolerance to a previously-transplanted organ would be transformative.”