Study comparing rapcabtagene autoleucel and rituximab in patients with severe refractory diffuse cutaneous systemic sclerosis

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What is this study about?

This study focuses on people with diffuse cutaneous systemic sclerosis (dcSSc), a severe autoimmune disease that causes hardening of the skin and can affect internal organs. The main treatment being tested is rapcabtagene autoleucel (also known as YTB323), which is a type of cell therapy where a patient’s own immune cells are modified to fight the disease. This treatment will be compared to rituximab, which is an existing medication used to treat autoimmune conditions.

The purpose of this research is to determine if rapcabtagene autoleucel is more effective than rituximab in treating severe dcSSc that has not responded well to previous treatments. Before receiving the main treatment, patients may receive preparation medications including cyclophosphamide, fludarabine phosphate, and tocilizumab. All medications will be given through an intravenous line directly into the bloodstream.

Throughout the study, which lasts for 52 weeks, doctors will monitor changes in lung function, skin thickness, and ability to perform daily activities. They will also track any side effects that may occur during or after treatment. The study will continue to follow participants for several years to understand the long-term effects of the treatment.

1 Initial Treatment Phase

You will receive lymphodepletion therapy consisting of fludarabine phosphate and cyclophosphamide through intravenous infusion

This preparatory treatment helps your body receive the main therapy

2 Main Treatment Administration

You will receive a single infusion of rapcabtagene autoleucel (YTB323) through intravenous administration

This is a specialized treatment that uses modified immune cells to target your condition

3 Monitoring Period

Regular assessments will track your progress over 52 weeks

Medical staff will measure changes in your lung function, skin condition, and overall health status

Your ability to perform daily activities will be evaluated throughout this period

4 Safety Evaluations

Regular health checks will include blood tests, vital signs monitoring, and heart activity recordings (ECG)

If needed, you may receive tocilizumab through intravenous infusion to manage specific side effects

Any health changes or side effects will be documented and addressed

5 Final Assessment

At week 52, a comprehensive evaluation will determine the effectiveness of the treatment

This includes measuring improvements in your condition using specialized assessment tools

Long-term follow-up will continue to monitor your health status

Who Can Join the Study?

  • You must be diagnosed with diffuse cutaneous systemic sclerosis (dcSSc) according to specific medical criteria established by rheumatology experts
  • Your disease symptoms (not including Raynaud’s phenomenon – a condition where fingers and toes feel numb and cold) must have started within the last 7 years. These symptoms may include:
    • Swollen hands
    • Hardening of the skin
    • Sores on fingers or toes
    • Joint pain
    • Difficulty breathing
  • You must have severe, progressive disease with at least one of these conditions:
    • Progressive lung involvement (breathing problems related to systemic sclerosis)
    • Severe, worsening skin involvement (skin hardening that is getting worse)
    • Heart problems related to systemic sclerosis
  • Both men and women can participate in this study
  • Adults of all ages can participate

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Previous treatment with rituximab (a type of medication that affects immune system cells)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of severe allergic reactions to biological treatments
  • Current pregnancy or breastfeeding
  • Significant heart problems or uncontrolled high blood pressure
  • Severe kidney or liver problems
  • Active cancer or history of cancer in the past 5 years (except for successfully treated skin cancer)
  • Major surgery within 8 weeks before starting the study
  • Participation in other clinical trials within 30 days before this study
  • Mental conditions that could interfere with following study procedures
  • Substance abuse within the past year
  • Any condition that, in the opinion of study doctors, would make participation unsafe
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario De Salamanca Salamanca Spain
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Hospital Olomouc Olomouc Czechia
Semmelweis University Budapest Hungary
Ryjogzppebegbx Utkde Prague Czechia
Kidixdqj Nngslistx Nürnberg Germany
Uvkizkbfbf On Dwfdiubd Debrecen Hungary
Hkdziyfh Vhzo dovuzkiw Barcelona Spain
Fxiiyljgva Iwjbhqbfy foi Torjdkushidvg Mblvspqp ako Pvntthkslatr Isos Frankfurt Germany
Ugvylbenwm Hjexedqp Cxgiyjv Cologne Germany
Foiogwecsj Ivqqy Cn Gwxspf Oszwijcw Meypplfq Phumpvobpmg Milan Italy
Fcmjzgtzkr Ibyko Pgvewrsefdx Skb Mmiyuo Pavia Italy
Ussphabyyimt Muuglto Cpcgcwr Udsepab Utrecht The Netherlands
Chxvtnz Uzaaomtqsllknfsmmndz Bbyuyo Kik Berlin Germany
Izhom Ojqoxcvu Pzshfvmkhak Sys Mxwlssw Genoa Italy
Hpgmtig Kazqcnjpdgl Djm Womlzk Gifbrtbucipwdfvfjyd Vienna Austria
Cufzky Htreayntijs Ubqijshyrjite Dw Mauutmfcyvj Montpellier France
Uwuczexcfedczntkk Pvyefyeyaqz Dtznk Misjhj Ancona Italy
Uqnrefnrbhte De Sipmmggo Dj Cxvxytastd Santiago De Compostela Spain
Mxmrlix Ckpajr &ccifsk Ubwvbkuisp Ow Fumngeno Freiburg Im Breisgau Germany
Ckqjfz Hqqarvwwgdm Uobbfhjtcndgg Ds Rpfwyy Rennes France
Hfxlxjvj Dm Lp Swwys Coip I Sagy Pat Barcelona Spain
Atmjhjz Okassvkhhjv Pere Geasuenr Xvzwz Bergamo Italy
Udbfvdxidjss Zkrghiahhz Gqmm Gent Belgium
Uvosvncoybofeajcaqoxs Sbanuoyhuivvqseuec Ach Kiel Germany
Adwjpgb Sbdgdcxfq Urngkkkcguoig Fluxtt Cdnxhmee Udine Italy
Crasny Hrasgigdlqw Lzfs Shl Pierre Benite France
Hltyujuu Uzliarzpgebdi 1k Df Oxvquwr Madrid Spain
Hexsyadz Uemhxjandhcmx Mqknkeh Dy Viveqijmlo Santander Spain
Ugyxdqtsge Dtrwj Sdruo Da Bbrvtzr Brescia Italy
Uarzxkhvtyfgfdcfsobwm Lwvmpfw Ahf Leipzig Germany
Hhxwhafg Ualofcxzrknilj Szxxcdmmdp &onzjfl Hsmwxwl dh Huexeruewxq STRASBOURG, Alsace France
Argnirc Okbaqsdcwpe Uxasshyyfxusc Pnlpfw Pisa Italy
Czikqc Hbrnvofdrzp Uhihzxwdxooyr Ds Dcnmu Dijon France
Axdvjo Uyydxqdgvm Haslfswc Aarhus Denmark
Uffqdlnqwk Cqimrranw Dwl Srxjp Cpvuu Rome Italy
Lnbxa Uxoieamrmwfm Mtrngro Clsukoc (zpmgh Leiden The Netherlands
Mjcgmwofxdcxemfqeomlgeymih Hxsbbisgkiaydlka Halle (Saale) Germany
Hdjnmvfv Sraax Majgp Dlnpw Msmsxnswwdzd Perugia Italy
Skylson Swtisvxxyzhcrvu Nr I W Bynmuwv Sawcv Bytom Poland
Adddnlj Strdicioz Lsorqd Dg Pjwapra Pescara Italy
Ocsmoodhncxtvabelxbmfvykbuis Sdzmhqv Ksnfkhdjf Iq Wpteokf Daac Umrzklsrzupo Mxwvqoenls Iu Kmqflj Mjmldrrbqsvukxg W Puqmgigq Poznan Poland
Cwbqnv Hezuyxjugrn Uvoqpfgzzzgaw Dk Byubsyvn Bordeaux France
Hwwzchtc Ctqvjc Dm Lqws Lyon France
Aruzgchumh Portauio Hybphumb Dl Peohs Paris France
Cmmbfl Hhrarvqoupt Uvuqcjykobscl Dt Tcufdnrb Toulouse France
Mfpjfpt Uqkipctmke Ok Gxxm Graz Austria
Uzbwhmmyaryxbmzakkzai Uee Apa Ulm Germany
Npwgxwtt Ipoudksq Owhefqbod Ivd Mzclv Shxfmiamszrehbdrzq Pvojixuki Iwcnplqg Botrxuyx Gliwice Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
02.12.2024
Belgium Belgium
Recruiting
02.12.2024
Czechia Czechia
Recruiting
02.12.2024
Denmark Denmark
Recruiting
02.12.2024
France France
Recruiting
02.12.2024
Germany Germany
Recruiting
02.12.2024
Hungary Hungary
Recruiting
02.12.2024
Italy Italy
Recruiting
02.12.2024
Poland Poland
Not yet recruiting
02.12.2024
Spain Spain
Recruiting
02.12.2024
The Netherlands The Netherlands
Recruiting
02.12.2024

Trial locations

Rapcabtagene autoleucel is a type of cell therapy where a patient’s own T cells (a type of immune cell) are modified in a laboratory. These modified cells are designed to target specific cells in the body that are involved in systemic sclerosis, a serious autoimmune condition affecting the skin and internal organs. The therapy is given as a single infusion into the bloodstream.

Rituximab is an antibody medication that works by targeting and reducing certain types of B cells (immune cells) in the body. It is commonly used to treat various autoimmune conditions and certain types of cancer. The medication is given through an infusion into the bloodstream and works by modifying the immune system’s response.

Investigated Diseases:

Diffuse cutaneous systemic sclerosis (dcSSc) – A rare autoimmune disease that causes hardening and tightening of the skin and connective tissues throughout the body. The condition begins with inflammation and swelling of the skin, which later leads to excessive collagen production causing skin thickening. It affects large areas of the skin, particularly on the trunk, face, and limbs. The disease typically progresses relatively quickly over the first few years after onset. Internal organs may also be affected as the condition develops. The term “diffuse” refers to the widespread nature of skin involvement, distinguishing it from other forms of systemic sclerosis.

Trial ID:
2023-510380-34-00
Protocol code:
CYTB323K12201
Trial Phase:
Therapeutic exploratory (Phase II)

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