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

NCT ID: NCT06655896

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2032-08-30

Brief Summary

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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.

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Detailed Description

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This is a phase 2, multi-part, five-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. Participants in the rituximab arm whose disease is not fully controlled may receive rapcabtagene autoleucel treatment once the participant is confirmed to be eligible per protocol.

After end of study, participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Conditions

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Scleroderma, Diffuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The study investigator and the participant will be unblinded to the study treatment. A blinded assessor will perform the efficacy assessments to minimize bias in data collection.

Study Groups

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rapcabtagene autoleucel arm

rapcabtagene autoleucel

Group Type EXPERIMENTAL

rapcabtagene autoleucel

Intervention Type BIOLOGICAL

single infusion of rapcabtagene autoleucel

rituximab arm

rituximab

Group Type ACTIVE_COMPARATOR

rituximab

Intervention Type BIOLOGICAL

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

Interventions

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rapcabtagene autoleucel

single infusion of rapcabtagene autoleucel

Intervention Type BIOLOGICAL

rituximab

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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UCLA

Los Angeles, California, United States

Site Status RECRUITING

UCSF

San Francisco, California, United States

Site Status RECRUITING

UCSF

San Francisco, California, United States

Site Status RECRUITING

Sutter Health Network

San Pablo, California, United States

Site Status RECRUITING

FL Medical Clinic Orlando Health

Zephyrhills, Florida, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University Of Iowa

Iowa City, Iowa, United States

Site Status RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Michigan Med University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

James Cancer Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status RECRUITING

Avera Cancer

Sioux Falls, South Dakota, United States

Site Status RECRUITING

LDS Hospital

Salt Lake City, Utah, United States

Site Status RECRUITING

Novartis Investigative Site

Camperdown, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Novartis Investigative Site

Graz, , Austria

Site Status RECRUITING

Novartis Investigative Site

Vienna, , Austria

Site Status RECRUITING

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Novartis Investigative Site

Olomouc, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Prague, , Czechia

Site Status RECRUITING

Novartis Investigative Site

Aarhus N, , Denmark

Site Status RECRUITING

Novartis Investigative Site

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

Novartis Investigative Site

Dijon, , France

Site Status RECRUITING

Novartis Investigative Site

Lille, , France

Site Status RECRUITING

Novartis Investigative Site

Lyon, , France

Site Status RECRUITING

Novartis Investigative Site

Montpellier, , France

Site Status RECRUITING

Novartis Investigative Site

Paris, , France

Site Status RECRUITING

Novartis Investigative Site

Rennes, , France

Site Status RECRUITING

Novartis Investigative Site

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status RECRUITING

Novartis Investigative Site

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Novartis Investigative Site

Halle, Saxony-Anhalt, Germany

Site Status RECRUITING

Novartis Investigative Site

Jena, Thuringia, Germany

Site Status RECRUITING

Novartis Investigative Site

Berlin, , Germany

Site Status RECRUITING

Novartis Investigative Site

Mainz, , Germany

Site Status RECRUITING

Novartis Investigative Site

Nuremberg, , Germany

Site Status RECRUITING

Novartis Investigative Site

Ulm, , Germany

Site Status RECRUITING

Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, Hungary

Site Status RECRUITING

Novartis Investigative Site

Budapest, , Hungary

Site Status RECRUITING

Novartis Investigative Site

Haifa, , Israel

Site Status RECRUITING

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Ramat Gan, , Israel

Site Status RECRUITING

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Tel Aviv, , Israel

Site Status RECRUITING

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Ancona, AN, Italy

Site Status RECRUITING

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Bergamo, BG, Italy

Site Status RECRUITING

Novartis Investigative Site

Brescia, BS, Italy

Site Status RECRUITING

Novartis Investigative Site

Genova, GE, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Milan, MI, Italy

Site Status RECRUITING

Novartis Investigative Site

Pescara, PE, Italy

Site Status RECRUITING

Novartis Investigative Site

Perugia, PG, Italy

Site Status RECRUITING

Novartis Investigative Site

Pisa, PI, Italy

Site Status RECRUITING

Novartis Investigative Site

Pavia, PV, Italy

Site Status RECRUITING

Novartis Investigative Site

Roma, RM, Italy

Site Status RECRUITING

Novartis Investigative Site

Udine, UD, Italy

Site Status RECRUITING

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Novartis Investigative Site

Sendai, Miyagi, Japan

Site Status RECRUITING

Novartis Investigative Site

Suita, Osaka, Japan

Site Status RECRUITING

Novartis Investigative Site

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Novartis Investigative Site

Fukuoka, , Japan

Site Status RECRUITING

Novartis Investigative Site

Kyoto, , Japan

Site Status RECRUITING

Novartis Investigative Site

Utrecht, , Netherlands

Site Status RECRUITING

Novartis Investigative Site

Singapore, , Singapore

Site Status RECRUITING

Novartis Investigative Site

Seoul, , South Korea

Site Status RECRUITING

Novartis Investigative Site

Santiago Compostela, A Coruna, Spain

Site Status RECRUITING

Novartis Investigative Site

Santander, Cantabria, Spain

Site Status RECRUITING

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Barcelona, , Spain

Site Status RECRUITING

Novartis Investigative Site

Córdoba, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Madrid, , Spain

Site Status RECRUITING

Novartis Investigative Site

Málaga, , Spain

Site Status RECRUITING

Novartis Investigative Site

Salamanca, , Spain

Site Status RECRUITING

Novartis Investigative Site

Valencia, , Spain

Site Status RECRUITING

Novartis Investigative Site

Geneva, , Switzerland

Site Status RECRUITING

Novartis Investigative Site

Lausanne, , Switzerland

Site Status RECRUITING

Novartis Investigative Site

Zurich, , Switzerland

Site Status RECRUITING

Novartis Investigative Site

Taichung, , Taiwan

Site Status RECRUITING

Countries

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United States Australia Austria Brazil Czechia Denmark France Germany Hungary Israel Italy Japan Netherlands Singapore South Korea Spain Switzerland Taiwan

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

[email protected]
1-888-669-6682

Novartis Pharmaceuticals

Role: CONTACT

[email protected]
+41613241111

Facility Contacts

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Lauren Nam

Role: primary

[email protected]

Zilan Zheng

Role: primary

[email protected]
415-353-1301

Zilan Zheng

Role: primary

[email protected]
415-502-6627

Canary Jumawan

Role: primary

[email protected]

William Daily Johnston

Role: primary

[email protected]
+1 813 782 1234

Matthew Selle

Role: primary

[email protected]

Darby Donovan

Role: primary

[email protected]
319-356-2197

Bharath Miriyam

Role: primary

[email protected]
617-639-8760

Abigail Mattison

Role: primary

[email protected]
734-615-4762

Amanda DeGrote

Role: primary

[email protected]

Claire Carlin

Role: primary

[email protected]
614-293-3196

Issabell Melz

Role: primary

[email protected]
503-494-9021

Lauren Donelan

Role: primary

[email protected]
605-322-3296

Tara Sou

Role: primary

[email protected]
801-581-7715

Other Identifiers

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2023-510380-34-00

Identifier Type: OTHER

Identifier Source: secondary_id

CYTB323K12201

Identifier Type: -

Identifier Source: org_study_id

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