Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655896
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multi-part Randomized Open-label Assessor-blinded Active-controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy safety and tolerability of rapcabtagene autoleucel administered once following lymphodepletion in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab
Detailed Description:
This is a phase 2 multi-part three-year randomized open-label assessor-blinded multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab in participants with severe refractory diffuse cutaneous systemic sclerosis dcSSc This study comprises two cohorts
A Lead-in Cohort enrolling participants to receive rapcabtagene autoleucel
A Randomized Cohort enrolling participants to receive rapcabtagene autoleucel or rituximab
After end of study participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up LTFU period lasting up to 15 years after rapcabtagene autoleucel infusion This LTFU will be described in a separate study protocol
A Lead-in Cohort enrolling participants to receive rapcabtagene autoleucel
A Randomized Cohort enrolling participants to receive rapcabtagene autoleucel or rituximab
After end of study participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up LTFU period lasting up to 15 years after rapcabtagene autoleucel infusion This LTFU will be described in a separate study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None