Your session is about to expire
← Back to Search
CAR T-cell Therapy
Rapcabtagene Autoleucel for Myositis
Phase 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with active disease
Participant must meet criteria for severe myositis
Must not have
Inadequate organ function
Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare the effectiveness and safety of rapcabtagene autoleucel to another treatment in patients with severe refractory idiopathic inflammatory myopathies.
Who is the study for?
This trial is for men and women aged 18 to 65 with a confirmed diagnosis of severe myositis, who haven't responded well to previous treatments. They must have active disease symptoms and meet specific criteria for severity based on ACR/EULAR 2017 standards.
What is being tested?
The study compares the effectiveness and safety of a new therapy called Rapcabtagene autoleucel against an active comparator in patients with severe refractory idiopathic inflammatory myopathies (IIM). It's a Phase 2 trial where participants are randomly assigned to different treatment groups.
What are the potential side effects?
Potential side effects of Rapcabtagene autoleucel may include immune system reactions, infusion-related responses, fatigue, muscle or joint pain, and possible impacts on heart function due to underlying cardiomyopathy associated with myositis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My disease is currently active.
Select...
I have been diagnosed with severe muscle inflammation.
Select...
I am between 18 and 65 years old and have been diagnosed with myositis.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My organs are not functioning properly.
Select...
I am not allergic to any medications or ingredients in the study.
Select...
I have no conditions that would interfere with CAR-T therapy.
Select...
I have a muscle disease that is not caused by inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 104
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of participants achieving at least moderate improvement in Total Improvement Score (TIS) at Week 52
Secondary study objectives
Adjusted annual cumulative glucocorticoid dose up to Week 52
Change from baseline in Patient-Reported-Outcome Measurement Information System (PROMIS)-Fatigue 7a at Week 52
Change from baseline in percent predicted Forced Vital Capacity (FVC%) at Week 52
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Rapcabtagene autoleucelExperimental Treatment1 Intervention
Single infusion of rapcabtagene autoleucel (YTB323)
Group II: ComparatorActive Control1 Intervention
Investigator choice of treatment as per protocol
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,920 Previous Clinical Trials
4,254,564 Total Patients Enrolled
4 Trials studying Myositis
486 Patients Enrolled for Myositis