Clinical Trials Logo

Clinical Trial Summary

This is a multicenter, open-label study to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive Diffuse Cutaneous Systemic Sclerosis (dcSSc) at risk for organ failure.


Clinical Trial Description

The purpose of this multicenter, single-arm study is to evaluate the safety and tolerability and explore the efficacy of FCR001 cell therapy in adults with rapidly progressive dcSSc at risk for organ failure. It consists of 2 years of treatment and 3 years of follow-up, with the primary analysis performed at 24 months. FCR001 is a cell therapy product that is administered by intravenous (IV) infusion, following nonmyeloablative (NMA) conditioning. It consists of mobilized peripheral blood cells, facilitating cells, and αβ T cells. This therapy is designed to induce donor-specific tolerance by establishing sustained chimerism and to protect against graft versus host disease (GvHD), the major impediment for advancing allogeneic hematopoietic stem cell therapy (HSCT) as a potential therapy in patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05098145
Study type Interventional
Source Talaris Therapeutics Inc.
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date November 24, 2021
Completion date February 2027

See also
  Status Clinical Trial Phase
Completed NCT02161406 - A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT03222492 - Brentuximab Vedotin for Systemic Sclerosis Phase 1/Phase 2
Completed NCT04137224 - Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc) Phase 2
Not yet recruiting NCT04986605 - Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT02503644 - Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis Phase 2
Recruiting NCT04781543 - A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis Phase 2
Enrolling by invitation NCT05626751 - An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc) Phase 2
Terminated NCT04478994 - A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) Phase 1
Completed NCT03198689 - Brentuximab Vedotin in Early Diffuse Cutaneous Systemic Sclerosis Phase 2
Terminated NCT04680975 - Efficacy and Safety of Belumosudil in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Completed NCT00433186 - Mycophenolate Mofetil in Systemic Sclerosis Phase 1
Terminated NCT03919799 - KD025 in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Not yet recruiting NCT06152172 - CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101 Phase 1
Suspended NCT04166552 - Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Diffuse Cutaneous Systemic Sclerosis Phase 2
Not yet recruiting NCT06375005 - Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis Phase 2
Recruiting NCT05270668 - Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007) Phase 2
Recruiting NCT05168215 - Effectiveness of Bosentan Therapy in Patients With Systemic scleRosis and Progressive Digital ulcEr Disease.
Completed NCT04440592 - Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Diffuse Cutaneous Systemic Sclerosis Phase 2
Recruiting NCT05149768 - Open Label Extension Study of Brentuximab Vedotin in Early dcSSc Phase 2
Withdrawn NCT04138485 - Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc) Phase 2