Clinical trial • Phase I/II • Immunology
RAPCABTAGENE AUTOLEUCEL for Rheumatoid arthritis | Sjögren's syndrome
Phase I/II trial of RAPCABTAGENE AUTOLEUCEL for Rheumatoid arthritis | Sjögren's syndrome. open-label, none/not specified-controlled. 27 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Rheumatoid arthritis | Sjögren's syndrome
- Trial Stage
- Phase I/II
- Drug Modality
- Cell therapy | Small molecule | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-01-2025
- First CTIS Authorization Date
- 02-05-2025
Trial design
open-label, none/not specified-controlled Phase I/II trial in Germany, France, Spain and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 27
Eligibility
Recruits 27 Vulnerable population selected. "Signed informed consent must be obtained prior to participation in the study." No details on assent or guardian consent for minors are provided in the source documents..
- Pregnancy Exclusion
- Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study
- Vulnerable Population
- Vulnerable population selected. "Signed informed consent must be obtained prior to participation in the study." No details on assent or guardian consent for minors are provided in the source documents.
Inclusion criteria
- {"criterion_text":"-Signed informed consent must be obtained prior to participation in the study"}
- {"criterion_text":"-Men and women aged ≥ 18 years and ≤ 75 years at screening"}
- {"criterion_text":"-Difficult-to-treat rheumatoid arthritis: Diagnosis of rheumatoid arthritis"}
- {"criterion_text":"-Difficult-to-treat rheumatoid arthritis: XX"}
- {"criterion_text":"-Difficult-to-treat rheumatoid arthritis: Treatment failure of standard of care therapies"}
- {"criterion_text":"-Difficult-to-treat rheumatoid arthritis: Signs suggestive of active, progressive disease"}
- {"criterion_text":"-Severe refractory Sjogren's Disease: Diagnosis of Sjogren’s disease"}
- {"criterion_text":"-Severe refractory Sjogren's Disease: XX"}
- {"criterion_text":"-Severe refractory Sjogren's Disease: Severe systemic, refractory disease with moderate to high disease activity"}
Exclusion criteria
- {"criterion_text":"-Body Mass Index at screening of ≤17 or ≥40 kg/m2"}
- {"criterion_text":"-Any XX that needs immediate treatment other than XX impossible"}
- {"criterion_text":"-Clinically significant active, opportunistic, chronic or recurrent infection"}
- {"criterion_text":"-Sexually active males unwilling to use a condom during intercourse from the time enrollment"}
- {"criterion_text":"-Women of childbearing potential, unless they are using a highly effective method of contraception starting from the time of enrollment"}
- {"criterion_text":"-Female participants who are pregnant, breastfeeding or intending to conceive during the course of the study"}
- {"criterion_text":"-Inadequate organ function during screening"}
- {"criterion_text":"-History of lymphoproliferative disease or any known malignancy or history of malignancy"}
- {"criterion_text":"-History of bone marrow/hematopoietic stem cell or solid organ transplantation"}
- {"criterion_text":"-Any psychiatric condition or disability making compliance with treatment or informed consent impossible"}
- {"criterion_text":"-Any patients requiring medications prohibited by the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation","definition_or_measurement_approach":"Safety assessed by vital signs, adverse events, laboratory parameters and ECG evaluation (as listed in the primary endpoint text)."}
Secondary endpoints
- {"endpoint_text":"-Rapcabtagene autoleucel transgene concentrations by qPCR over time in peripheral blood; cellular kinetics parameters (Cmax, AUC, Tmax, T1/2, Clast, Tlast)","definition_or_measurement_approach":"Transgene concentrations measured by quantitative PCR (qPCR) in peripheral blood over time; cellular kinetics parameters include Cmax, AUC, Tmax, T1/2, Clast, Tlast as specified."}
Recruitment
- Planned Sample Size
- 27
- Recruitment Window Months
- 41
- Consent Approach
- Signed informed consent must be obtained prior to participation in the study. Adult informed consent forms are provided (documents list main ICFs). Available ICF/document languages in the submission include German, French, Spanish, Italian, Hungarian and English. No assent/guardian consent procedures for minors are provided in the source.
Geography
- Total Number Of Sites
- 19
- Total Number Of Participants
- 27
Germany
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 299
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- 2007: Klinik fuer Nephrologie und Rheumatologie
- Principal Investigator Name
- Jan Gerd Rademacher
- Principal Investigator Email
- jan-gerd.rademacher@med.uni-goettingen.de
- Contact Person Name
- Jan Gerd Rademacher
- Contact Person Email
- jan-gerd.rademacher@med.uni-goettingen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- 2006:Zentrum fuer Innere Medizin,Innere Medizin III
- Principal Investigator Name
- Anita Viardot
- Principal Investigator Email
- anita.viardot@uniklinik-ulm.de
- Contact Person Name
- Anita Viardot
- Contact Person Email
- anita.viardot@uniklinik-ulm.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- 2002:Klinik f Rheumatologie u Klinische Immunologie, Dep. Innere Medizin
- Principal Investigator Name
- Stephanie Finzel
- Principal Investigator Email
- stephanie.finzel@uniklinik-freiburg.de
- Contact Person Name
- Stephanie Finzel
- Contact Person Email
- stephanie.finzel@uniklinik-freiburg.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- 2001:Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
- Principal Investigator Name
- David Simon
- Principal Investigator Email
- david.simon@charite.de
- Contact Person Name
- David Simon
- Contact Person Email
- david.simon@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- 2004:Klinik I für Innere Medizin
- Principal Investigator Name
- Philipp Köhler
- Principal Investigator Email
- philipp.koehler@uk-koeln.de
- Contact Person Name
- Philipp Köhler
- Contact Person Email
- philipp.koehler@uk-koeln.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 2005: I. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- Julia.weinmann-menke@unimedizin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimedizin-mainz.de
France
- Earliest CTIS Part Ii Submission Date
- 14-04-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 294
- Number Of Sites
- 9
- Number Of Participants
- 7
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 1005:Rhumatologie
- Principal Investigator Name
- Christophe RICHEZ
- Principal Investigator Email
- christophe.richez@chu-bordeaux.fr
- Contact Person Name
- Christophe RICHEZ
- Contact Person Email
- christophe.richez@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- 1001:Rheumatologie
- Principal Investigator Name
- Valerie DEVAUCHELLE-PENSEC
- Principal Investigator Email
- Valerie.devauchelle-pensec@chu-brest.fr
- Contact Person Name
- Valerie DEVAUCHELLE-PENSEC
- Contact Person Email
- Valerie.devauchelle-pensec@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- 1003:Medecine Interne
- Principal Investigator Name
- Eric HACHULLA
- Principal Investigator Email
- Eric.hachulla@chu-lille.fr
- Contact Person Name
- Eric HACHULLA
- Contact Person Email
- Eric.hachulla@chu-lille.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- 1006:Rhumatologie
- Principal Investigator Name
- Xavier MARIETTE
- Principal Investigator Email
- Xavier.mariette@aphp.fr
- Contact Person Name
- Xavier MARIETTE
- Contact Person Email
- Xavier.mariette@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 1004:Rhumatologie
- Principal Investigator Name
- Jacques MOREL
- Principal Investigator Email
- j-morel@chu-montpellier.fr
- Contact Person Name
- Jacques MOREL
- Contact Person Email
- j-morel@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 1005:Rhumatologie
- Principal Investigator Name
- Christophe RICHEZ
- Principal Investigator Email
- christophe.richez@chu-bordeaux.fr
- Contact Person Name
- Christophe RICHEZ
- Contact Person Email
- christophe.richez@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 1005:Rhumatologie
- Principal Investigator Name
- Christophe RICHEZ
- Principal Investigator Email
- christophe.richez@chu-bordeaux.fr
- Contact Person Name
- Christophe RICHEZ
- Contact Person Email
- christophe.richez@chu-bordeaux.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 1006:Rhumatologie
- Principal Investigator Name
- Xavier MARIETTE
- Principal Investigator Email
- Xavier.mariette@aphp.fr
- Contact Person Name
- Xavier MARIETTE
- Contact Person Email
- Xavier.mariette@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 1004:Rhumatologie
- Principal Investigator Name
- Jacques MOREL
- Principal Investigator Email
- j-morel@chu-montpellier.fr
- Contact Person Name
- Jacques MOREL
- Contact Person Email
- j-morel@chu-montpellier.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 10-04-2025
- Latest Decision Or Authorization Date
- 05-02-2026
- Processing Time Days
- 301
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 5002: Rheumatology
- Principal Investigator Name
- Sara Marsal Barril
- Principal Investigator Email
- sara.marsal@vhir.org
- Contact Person Name
- Sara Marsal Barril
- Contact Person Email
- sara.marsal@vhir.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- 5001: Rheumatology
- Principal Investigator Name
- Francisco Javier Bachiller Corral
- Principal Investigator Email
- fbachiller@salud.madrid.org
- Contact Person Name
- Francisco Javier Bachiller Corral
- Contact Person Email
- fbachiller@salud.madrid.org
Hungary
- Earliest CTIS Part Ii Submission Date
- 01-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- #3001: Phase I Centre
- Principal Investigator Name
- Eva Vegh
- Principal Investigator Email
- evegh@dpckorhaz.hu
- Contact Person Name
- Eva Vegh
- Contact Person Email
- evegh@dpckorhaz.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 02-04-2026
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- IRCCS Azienda Ospedaliera Metropolitana
- Department Name
- # 4001; U.O. Ematologia e Centro Trapianti
- Principal Investigator Name
- Raffaele DE PALMA
- Principal Investigator Email
- raffaele.depalma@unige.it
- Contact Person Name
- Raffaele DE PALMA
- Contact Person Email
- raffaele.depalma@unige.it
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- code:1
- Name
- Pharma Bio-Research Group
- Responsibilities
- Analysis of humoral IG; code:4
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Ancillary supplies for leukapheresis and infusion
- Name
- Icon Clinical Research Limited
- Responsibilities
- code:1
- Name
- RWS Life Sciences Inc.
- Responsibilities
- PRO translation services
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- code:4
- Name
- Bioagilytix Labs LLC
- Responsibilities
- Analysis of cellular IG; code:4
- Name
- Navigate Biopharma Services Inc.
- Responsibilities
- code:4
- Name
- Eurofins Genomics Europe AgriGenomics Products & Services A/S
- Responsibilities
- Pharmacogenetics; code:4
- Name
- Syneos Health Inc.
- Responsibilities
- code:1
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"Analysis of humoral IG; code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Ancillary supplies for leukapheresis and infusion","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"PRO translation services","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Analysis of cellular IG; code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"Pharmacogenetics; code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- YTB323
- Active Substance
- RAPCABTAGENE AUTOLEUCEL
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- 1
- Investigational Product Name
- FLUDARABINE PHOSPHATE
- Active Substance
- FLUDARABINE PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- 2
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- 2
- Investigational Product Name
- TOCILIZUMAB
- Active Substance
- TOCILIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- 2
- Combination Treatment
- Yes
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