A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis
(FREEDOM-3 Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new cell therapy called FCR001 for adults with severe skin disease that can cause organ failure. The treatment involves giving special donor cells through an IV drip to help the body accept these new cells without attacking them. FCR001 is a mobilized blood product enriched in stem cells and facilitating cells, which has been used before in patients with kidney transplants.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions a washout period for scleroderma-specific therapies. You may need to discuss your current medications with the trial team to understand any specific requirements.
How does the drug FCR001 differ from other treatments for this condition?
FCR001 is unique because it involves the neonatal Fc receptor (FcRn), which helps extend the lifespan of certain proteins in the body, potentially improving the effectiveness of treatments for autoimmune diseases, infections, and cancer. This mechanism is different from standard treatments that may not utilize FcRn to enhance drug delivery or prolong drug action.12345
Research Team
Joel Weinthal, MD
Principal Investigator
Talaris Therapeutics
Eligibility Criteria
Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Nonmyeloablative Conditioning
Participants undergo nonmyeloablative conditioning prior to receiving FCR001 cell therapy
Treatment
Participants receive a single infusion of FCR001 cell therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- FCR001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Talaris Therapeutics Inc.
Lead Sponsor