Scleroderma, DiffusePhase 2NCT06655896
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
A Phase 2 study testing rapcabtagene autoleucel and rituximab in people with Scleroderma, Diffuse, run by Novartis Pharmaceuticals at 93 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Scleroderma, Diffuse
- What is being tested?
- rapcabtagene autoleucel and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 93 sitesin 22 countries
- Study dates
- 29 Oct 2024to 30 Aug 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- 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
- All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.
Who cannot join
- 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.
- Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
- Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
- 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.
- Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
- Participants with pre-existing pulmonary hypertension.
Show all 10Show fewer
- Significant renal pathology at Screening.
- Participants with uncontrolled stage II hypertension at Screening.
- Vaccination with live attenuated vaccines within 6 weeks prior to randomization.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
93 sites in 22 countries.
93 sites in 22 countries
United States13 sites
Michigan Med University of Michigan
Ann Arbor, Michigan, 48109-5271
Boston Medical Center
Boston, Massachusetts, 02118
Northwestern University
Chicago, Illinois, 60611
James Cancer Hospital
Columbus, Ohio, 43210
University Of Iowa
Iowa City, Iowa, 52242
UCLA
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Oregon Health Sciences University
Portland, Oregon, 97239
LDS Hospital
Salt Lake City, Utah, 84143
UCSF
San Francisco, California, 94115
Sutter Health Network
San Pablo, California, 94806
Avera Cancer
Sioux Falls, South Dakota, 57105
FL Medical Clinic Orlando Health
Zephyrhills, Florida, 33542
Italy12 sites
Novartis Investigative Site
Ancona, AN, 60020
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Perugia, PG, 06129
Novartis Investigative Site
Pescara, PE, 65124
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Udine, UD, 33100
Spain11 sites
Novartis Investigative Site
Barcelona, 08035
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Málaga, 29010
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Salamanca, 37007
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Santiago Compostela, A Coruna, 15706
Novartis Investigative Site
Valencia, 46026
Germany10 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
Novartis Investigative Site
Göttingen, Lower Saxony, 37075
Novartis Investigative Site
Halle, Saxony-Anhalt, 06120
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Leipzig, Saxony, 04103
Novartis Investigative Site
Lübeck, 23538
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Nuremberg, 90419
Novartis Investigative Site
Ulm, 89081
France8 sites
Novartis Investigative Site
Bordeaux, 33076
Novartis Investigative Site
Dijon, 21000
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Lyon, 69003
Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Rennes, 35033
Novartis Investigative Site
Strasbourg, 67091
Japan7 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138603
Novartis Investigative Site
Fukuoka, 8128582
Novartis Investigative Site
Ishikawa, 9208641
Novartis Investigative Site
Kyoto, 6068507
Novartis Investigative Site
Sapporo, Hokkaido, 0608648
Novartis Investigative Site
Sendai, Miyagi, 9808574
Novartis Investigative Site
Suita, Osaka, 5650871
Brazil5 sites
Novartis Investigative Site
Barretos, São Paulo, 14784-400
Novartis Investigative Site
Curitiba, Paraná, 80030-110
Novartis Investigative Site
Salvador, Estado de Bahia, 41253-190
Novartis Investigative Site
São Paulo, São Paulo, 01232-010
Novartis Investigative Site
São Paulo, São Paulo, 01308-050
Austria3 sites
Novartis Investigative Site
Graz, 8036
Novartis Investigative Site
Vienna, 1090
Novartis Investigative Site
Vienna, 1140
Israel3 sites
Novartis Investigative Site
Haifa, 3109601
Novartis Investigative Site
Ramat Gan, 5265601
Novartis Investigative Site
Tel Aviv, 6423906
South Korea3 sites
Novartis Investigative Site
Seoul, Seoul, 06351
Novartis Investigative Site
Seoul, 04763
Novartis Investigative Site
Seoul, 06591
Switzerland3 sites
Novartis Investigative Site
Geneva, 1211
Novartis Investigative Site
Lausanne, 1011
Novartis Investigative Site
Zurich, 8091
Argentina2 sites
Novartis Investigative Site
CABA, C1181ACH
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KEH
Australia2 sites
Novartis Investigative Site
Camperdown, New South Wales, 2050
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Czechia2 sites
Novartis Investigative Site
Olomouc, 779 00
Novartis Investigative Site
Prague, 128 00
Hungary2 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
United Kingdom1 site
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis
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.
Read the detailed description
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
- Scleroderma, Diffuse
- Being tested
- rapcabtagene autoleucel, rituximab
- Keywords
- Diffuse cutaneous systemic sclerosis (dcSSc), Scleroderma, Diffuse, revised Composite Response Index in Systemic Sclerosis (rCRISS), modified Rodnan skin score (mRSS), forced vital capacity (FVC)
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rapcabtagene autoleucelBiological
single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.
rituximabBiological
rituximab intravenous infusion (i.v.) as per protocol
| Study group | Role | What they receive |
|---|---|---|
| rapcabtagene autoleucel arm | Experimental | rapcabtagene autoleucel Receives: Biological: rapcabtagene autoleucel |
| rituximab arm | Active comparator | rituximab Receives: Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52.
To demonstrate the superiority of rapcabtagene autoleucel as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52.
This response is assessed across 5 assessment domains: (1) modified Rodnan Skin Score (mRSS), (2) Health Assessment Questionnaire Disability Index (HAQ-DI), (3) patient global assessment (PGA), (4) physician global assessment (PhGA) and (5) percent-predicted forced vital capacity (FVC%).
Measured: Week 52
Secondary outcomes (4)
Change from baseline in Forced Vital Capacity (FVC)% predicted at Week 52
Change from baseline in FVC % predicted
Measured: Baseline, Week 52
Change from baseline in modified Rodnan Skin Score (mRSS) at Week 52.
The modified Rodnan Skin Score (mRSS) is a clinical tool used to assess skin thickness in patients with systemic sclerosis (scleroderma). It involves palpating the skin and rating its thickness on a scale from 0 to 3 across 17 different body sites. The total score is the sum of the individual scores from all 17 sites, ranging from 0 (normal) to 51 (severe).
Measured: Baseline, Week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52.
The Health Assessment Questionnaire Disability Index (HAQ-DI) is a widely used tool to measure a patient's level of functional ability and disability. It consists of 20 questions that cover eight domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Each question is rated on a scale from 0 (without difficulty) to 3 (unable to do).
Measured: Baseline, Week 52
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
The distribution of adverse events will be done via the analysis of frequencies for Adverse Event (AEs) and Serious Adverse Event (SAEs) through the monitoring of relevant clinical and laboratory safety parameters.
Measured: Up to end of study, assessed up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start29 Oct 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, DiffuseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655896
- Sponsor's protocol ID
- CYTB323K12201
- Other IDs
- 2023-510380-34-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multi-part, Randomized, Open-label, Assessor-blinded, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Rituximab Treatment in Participants With Severe Refractory Diffuse Cutaneous Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06655896
- Acronym / sponsor ID
- CYTB323K12201
- Conditions
- Scleroderma, Diffuse
- Keywords
- Diffuse cutaneous systemic sclerosis (dcSSc), Scleroderma, Diffuse, revised Composite Response Index in Systemic Sclerosis (rCRISS), modified Rodnan skin score (mRSS), forced vital capacity (FVC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Aug 2032 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rapcabtagene autoleucel arm | Experimental | Biological: rapcabtagene autoleucelrapcabtagene autoleucel |
| rituximab arm | Active comparator | Biological: rituximabrituximab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
- Severe, progressive systemic sclerosis disease defined by at least one of the following:
- All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.
Key exclusion criteria (10 listed)
- 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.
- Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
- Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
- 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.
- Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rapcabtagene autoleucelsingle infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days. | Biological | rapcabtagene autoleucel arm |
| rituximabrituximab intravenous infusion (i.v.) as per protocol | Biological | rituximab arm |
Primary outcome
Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52.
Time frame: Week 52
To demonstrate the superiority of rapcabtagene autoleucel as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52. This response is assessed across 5 assessment domains: (1) modified Rodnan Skin Score (mRSS), (2) Health Assessment Questionnaire Disability Index (HAQ-DI), (3) patient global assessment (PGA), (4) physician global assessment (PhGA) and (5) percent-predicted forced vital capacity (FVC%).
4 secondary outcomes
Change from baseline in Forced Vital Capacity (FVC)% predicted at Week 52
Time frame: Baseline, Week 52
Change from baseline in modified Rodnan Skin Score (mRSS) at Week 52.
Time frame: Baseline, Week 52
Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52.
Time frame: Baseline, Week 52
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to end of study, assessed up to approximately 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
93 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rapcabtagene autoleucel and rituximab in people with Scleroderma, Diffuse, run by Novartis Pharmaceuticals at 93 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Italy, Spain, Germany, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52. (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.