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CAR T-cell Therapy

Rapcabtagene Autoleucel for Systemic Sclerosis

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
Severe, progressive systemic sclerosis disease defined by at least one of the following: Progressive systemic sclerosis-associated interstitial lung disease, Severe, progressive systemic sclerosis skin disease, Clinically significant systemic sclerosis-associated cardiac involvement at Screening
Be older than 18 years old
Must not have
Participants with pre-existing pulmonary hypertension
Participants with uncontrolled stage II hypertension at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 156
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare the effectiveness, safety, and tolerance of rapcabtagene autoleucel with rituximab in patients with severe diffuse cutaneous systemic sclerosis.

Who is the study for?
This trial is for individuals with severe refractory diffuse cutaneous systemic sclerosis, a type of scleroderma affecting the skin and sometimes internal organs. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.
What is being tested?
The study is testing rapcabtagene autoleucel, given once after preparing the body's immune system (lymphodepletion), against rituximab to see which is more effective and safe for treating severe systemic sclerosis.
What are the potential side effects?
While specific side effects are not listed, treatments like rapcabtagene autoleucel and rituximab can cause immune reactions, infusion-related symptoms, fatigue, possible organ inflammation, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition involves severe lung, skin, or heart issues due to systemic sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with high blood pressure in the lungs.
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My high blood pressure is not under control.
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I am allergic to ingredients in rapcabtagene autoleucel or rituximab.
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I do not have severe kidney issues like SSc renal crisis or glomerulonephritis.
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I have not received any live vaccines in the last 6 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 156 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52.
Secondary study objectives
Achievement of Week 156 progression-free survival with respect to disease progression criteria.
Change from baseline in Forced Vital Capacity (FVC)% predicted at Week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52.
+2 more

Side effects data

From 2014 Phase 3 trial • 519 Patients • NCT01332994
15%
Nasopharyngitis
6%
Hypertension
1%
Bursitis
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ/TCZ or TCZ/RTX

Awards & 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 autoleucel armExperimental Treatment1 Intervention
rapcabtagene autoleucel
Group II: rituximab armActive Control1 Intervention
rituximab

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,912 Previous Clinical Trials
4,252,617 Total Patients Enrolled
1 Trials studying Scleroderma
10 Patients Enrolled for Scleroderma
~57 spots leftby Dec 2028
Unbiased ResultsWe believe in providing patients with all the options.
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