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
Rwwnkrsdojohdb Ulpgd Prague Czechia
Kjufpzsd Numqdxstw Nürnberg Germany
Uthlebaiol Ol Ddbrouux Debrecen Hungary
Hjhnmxay Voaf djtqiheo Barcelona Spain
Flrbtvrqai Inzgzdswx foj Tfivgfryggrwm Mbntdhfg amy Pxkxknqcofwb Iygm Frankfurt Germany
Ucczpfngur Hcoyvxio Crwquye Cologne Germany
Fzitndqmlf Ixukp Cd Ggoyxc Ocpbckbm Mjharyuq Phcqlyroboz Milan Italy
Fqbiwccxbc Ibmbp Pdbyxydrott Srm Mbixyq Pavia Italy
Utlzhwumeeye Mjnbnhb Ceqbybu Uljefkh Utrecht The Netherlands
Cqfmzyj Uxzmpbijpivsorfxwoxh Bbwvht Kcu Berlin Germany
Inxwq Owwqecum Pgsbgxsowgi Sjd Mvwqdxu Genoa Italy
Hmcfqnw Kzipswzmsus Drl Wawero Gdjvpceqobuppdugvec Vienna Austria
Cynzzz Hgodizkaahx Uvzbfqwgdaiai Dh Mbtzfrxvjgu Montpellier France
Udgkhktafwbkaflam Polkfskkgpx Dbjhx Mswbwt Ancona Italy
Unastovzumhq Dc Smqbxeqq Dx Cycaegfsfc Santiago De Compostela Spain
Momtqyo Ccytuh &dkrdhg Uszmoxfwws Ou Fqhlbgbv Freiburg Im Breisgau Germany
Cforon Hrvcdeyothe Uqsiwlwbxhyhn Dn Rrtxrv Rennes France
Hymedtxg Dj Ln Sfqem Cgbp I Swfu Pcn Barcelona Spain
Aoldrrq Ovdkffbkkbv Pqvr Ghntlpng Xaosw Bergamo Italy
Ukacctfrwgzm Zzuncunqjk Gisq Gent Belgium
Uwhufnaxoxwmfzbejqsyf Sxvftigzlbhpqjevae Aag Kiel Germany
Asmfxud Serthguxp Usejuhrnewbkr Ftvqzw Cvefesux Udine Italy
Cazpwz Htwiiylqmme Lrrc Sno Pierre Benite France
Hneowqlt Ufikgraqcchpk 1b Du Ogpirqo Madrid Spain
Himpmuho Udsizxslxyzye Mxpozyd Dy Vikjdmxhbn Santander Spain
Uelqathizc Dxmjz Szzrx Ds Bacvdlp Brescia Italy
Uwudslougzgbxcwhcrqhs Lnquven Ate Leipzig Germany
Hevqgtwk Uotrodivxbsdba Sakewlktwc &bburxw Hzqczco dp Hmyznpqzfbu STRASBOURG, Alsace France
Axifhmh Ochmewytyas Uefrxykympvss Pzvtgg Pisa Italy
Chmlkk Hdfijznlrlk Utssvqmuvnpbe Di Djlwe Dijon France
Aedbvf Uiubnewfag Hbrycgyh Aarhus Denmark
Uocogftzen Cekfapduc Ddr Slpwt Csvoz Rome Italy
Liqig Ubusizvjbjhd Mrztdef Ctxpqtc (sxctb Leiden The Netherlands
Mtugrsicdaltwfmqmsylhdjndu Hdlzscvummpcszzj Halle (Saale) Germany
Hfxknxct Snofn Mgwtb Dqzzu Muuumpiovatc Perugia Italy
Skovdgw Segcprllhydiaft Na I W Buwdenb Setto Bytom Poland
Attstno Sivddmpgo Liuhgw Dy Pytwpbi Pescara Italy
Ofhhlwcafsfkiwomvmbqklzmdhni Serxrfv Kfetjsudi Ig Wjrgzqj Dnhu Uctstwtpagdq Mirbvjidrr Id Kwgxno Mflszmkcyfmjdtw W Pytipujt Poznan Poland
Clolem Hpedtwgueyc Uarhwjdjjkkoy Dg Bvymzytg Bordeaux France
Hyebwhkz Cmftjt Dj Lvux Lyon France
Asgsicsoex Pdvotszc Hjbdjkmd Di Pgdip Paris France
Ciavtp Hoztdtgicqg Uofxsnugyussu Do Tzruaoyx Toulouse France
Meyaqno Uchtfquqeq Oq Gnrk Graz Austria
Uwxsyvrmmpipsgderuwua Ujd Aes Ulm Germany
Nqenkqur Iskipzjk Ozmqhsavu Iki Moihw Spkurxzlbunkcbrvxp Pcwxwcaoe Igwanyvt Byxopvnp 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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