0

A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis

(FREEDOM-3 Trial)

CO
Overseen ByClinical Operations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Talaris Therapeutics Inc.
Must be taking: Immunosuppressive therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JW

Joel Weinthal, MD

Principal Investigator

Talaris Therapeutics

Eligibility Criteria

Inclusion Criteria

Age ≥ 18 and < 70 years
Diagnosis of diffuse cutaneous systemic sclerosis
Disease duration < 5 years from first non-Raynaud's phenomenon symptom
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nonmyeloablative Conditioning

Participants undergo nonmyeloablative conditioning prior to receiving FCR001 cell therapy

2 weeks

Treatment

Participants receive a single infusion of FCR001 cell therapy

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

  • FCR001
Participant Groups
1Treatment groups
Experimental Treatment
Group I: FCR001Experimental Treatment1 Intervention
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood cells and delivered as a single infusion with a nonmyeloablative conditioning regimen.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Talaris Therapeutics Inc.

Lead Sponsor

Trials
12
Recruited
100+

References

Research progress on neonatal Fc receptor and its application. [2022]
Differential B cell expression of mouse Fc receptor homologs. [2007]
Fc receptor homolog 3 is a novel immunoregulatory marker of marginal zone and B1 B cells. [2019]
Prognostic significance of Fc receptor-like 1 in patients with chronic lymphocytic leukemia, hairy cell leukemia, and various B-cell non-Hodgkin's lymphoma. [2020]
The human gene encoding the heavy chain of the major histocompatibility complex class I-like Fc receptor (FCGRT) maps to 19q13.3. [2018]