Who can participate in FREEDOM-3?
in the FREEDOM-3 trial.
Overview of the FREEDOM-3 clinical trial
Could you help your patients step into FREEDOM?
The FREEDOM-3 clinical trial is a phase 1/2a, single-arm, multi-center, open-label trial that will evaluate the safety, tolerability, and efficacy of an allogeneic hematopoietic stem cell transplant with an investigational cell therapy called FCR001 in people with rapidly progressing dcSSc and who are at risk for organ failure.
To learn more about the FREEDOM-3 clinical trial please visit ClinicalTrials.gov: NCT05098145
Who can take part in FREEDOM-3?
We are looking for up to 18 recipient and donor pairs to take part.
Recipients must have dcSSc and:
Be between 18 and 69 years old
Be willing to take part in the trial for about five years
Have early pulmonary, renal, or cardiac involvement
Have received or are currently receiving at least one immunosuppressive medicine to treat dcSSc
Have a donor who is also willing and eligible to take part*
*Recipients and donors may be related (e.g., a biological child, sibling, cousin), but they do not have to be. All donors must be willing to donate peripheral blood stem cells and meet other eligibility criteria to participate.
Both recipients and donors will undergo human leukocyte antigen (HLA) testing to confirm that they are a compatible match for the stem cell transplant. The study team will discuss this with potential participants in more detail.
Could your patients participate?
in the FREEDOM-3 trial.
FREEDOM-3 recipient timeline
All recipients receive (FCR001)
About 5 years with at least 21 to 33 total study visits
Mobilization/apheresis
All participants will complete mobilization (with filgrastim) and apheresis
- Donors—to collect cells for FCR001
- Recipients—to collect autologous rescue product
Conditioning
- Recipients will receive conditioning medicines (fludarabine, cyclophosphamide, and mesna) and a single low dose of radiation
- Recipients will receive lisinopril to help prevent scleroderma renal crisis
Stem cell transplant
- Recipients will receive the investigational stem cell transplant
Monitoring period
- Recipients will receive conventional immunosuppressive medicines twice daily (mycophenolate [MMF] and tacrolimus)
- MMF may stop after six months and tacrolimus after one year if study criteria are met
- Recipients will have regular study visits after their transplant so the study team can continue to monitor their health
- Donors will have at least eight to ten study visits over about 15 months
Participants may experience side effects and/or health complications from the medicines,
investigational cell therapy, and/or assessments and procedures.
