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Clinical Trials in the UK / NCT06655896
Active, not recruiting Phase 2

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

NCT06655896 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2024-10-29
Last updated
2026-09-02

Condition(s) studied

Scleroderma, Diffuse

Investigational drug(s) / intervention(s)

rapcabtagene autoleucelrituximab

rapcabtagene autoleucel: single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.

rituximab: rituximab intravenous infusion (i.v.) as per protocol

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy. 2. Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit. 3. 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 4. All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients. Exclusion Criteria: 1. Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator. 2. Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab. 3. Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator. 4. Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy. 5. Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening. 6. Participants with pre-existing pulmonary hypertension. 7. Significant renal pathology at Screening. 8. Participants with uncontrolled stage II hypertension at Screening. 9. Vaccination with live attenuated vaccines within 6 weeks prior to randomization. Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
UCLA Los Angeles California
UCSF San Francisco California
Sutter Health Network San Pablo California
FL Medical Clinic Orlando Health Zephyrhills Florida
Northwestern University Chicago Illinois
University Of Iowa Iowa City Iowa
Boston Medical Center Boston Massachusetts
Michigan Med University of Michigan Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
James Cancer Hospital Columbus Ohio
Oregon Health Sciences University Portland Oregon
Avera Cancer Sioux Falls South Dakota
LDS Hospital Salt Lake City Utah
Novartis Investigative Site Córdoba Córdoba Province
Novartis Investigative Site CABA Argentina
Novartis Investigative Site Camperdown New South Wales
Novartis Investigative Site Darlinghurst New South Wales
Novartis Investigative Site Graz Austria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Ghent Belgium
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Curitiba Paraná
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site Olomouc Czechia
Novartis Investigative Site Prague Czechia
Novartis Investigative Site Aarhus N Denmark
Novartis Investigative Site Bordeaux France
Novartis Investigative Site Dijon France
Novartis Investigative Site Lille France
Novartis Investigative Site Lyon France
Novartis Investigative Site Montpellier France
Novartis Investigative Site Paris France
Novartis Investigative Site Rennes France
Novartis Investigative Site Strasbourg France
Novartis Investigative Site Freiburg im Breisgau Baden-Wurttemberg
Novartis Investigative Site Göttingen Lower Saxony
Novartis Investigative Site Leipzig Saxony

+ 53 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

More Novartis Pharmaceuticals trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06655896 on ClinicalTrials.gov ↗ ← All trials in the UK