Clinical trial • Phase II • Immunology

RAPCABTAGENE AUTOLEUCEL for Systemic lupus erythematosus | Lupus nephritis

Phase II trial of RAPCABTAGENE AUTOLEUCEL for Systemic lupus erythematosus | Lupus nephritis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Systemic lupus erythematosus | Lupus nephritis
Trial Stage
Phase II
Drug Modality
Cell therapy | Monoclonal antibody | Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
12-06-2024
First CTIS Authorization Date
30-09-2024

Trial design

Randomised, open-label, comparators (standard of care options) include: mycophenolate mofetil; voclosporin; cyclophosphamide; tacrolimus; mycophenolic acid; belimumab; rituximab; azathioprine. (doses and schedules not specified in the ctis data provided.)-controlled, adaptive Phase II trial in Norway, Romania, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparators (standard of care options) include: Mycophenolate mofetil; Voclosporin; Cyclophosphamide; Tacrolimus; Mycophenolic acid; Belimumab; Rituximab; Azathioprine. (Doses and schedules not specified in the CTIS data provided.)
Adaptive
Yes
Target Sample Size
73
Trial Duration For Participant
364

Eligibility

Recruits 73 Vulnerable population selected. Signed informed consent must be obtained from adult participants (aged 18–75). Country-specific subject information and ICF documents are provided (including ICFs and follow-up forms for pregnant participants, information for female partners, and parent/legal guardian documents where applicable)..

Vulnerable Population
Vulnerable population selected. Signed informed consent must be obtained from adult participants (aged 18–75). Country-specific subject information and ICF documents are provided (including ICFs and follow-up forms for pregnant participants, information for female partners, and parent/legal guardian documents where applicable).

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study."}
  • {"criterion_text":"- Men and women with SLE, aged ≥18 years and ≤75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE."}
  • {"criterion_text":"- Participant must be positive for at least one of the following autoantibodies at screening: antinuclear antibodies (ANA) at a titer (on HEp-2 cells or an equivalent positive test), or anti-dsDNA (above the ULN); or anti-Sm (above the ULN) as determined by a central laboratory."}
  • {"criterion_text":"- Active lupus nephritis without signs of significant chronicity as defined by: retest during screening of any of the lab assessments for inclusion is permitted with an Investigator’s justification. Active SLE with non-renal significant organ involvement as defined by: BILAG-2004 disease activity level (Isenberg et al 2005, Yee et al 2006, Yee et al 2010, Isenberg et al 2011) in at least 1 of the following: • BILAG-2004 Level A disease in ≥ 1 organ system within the past 3 months with at least BILAG B in the same organ system at screening • BILAG-2004 Level B disease in ≥ 2 organ systems at screening"}
  • {"criterion_text":"- points (Gladman et al 2002, Touma et al 2011), excluding points attributed to “fever”, “lupus headache”, \"alopecia\", and “organic brain syndrome."}

Exclusion criteria

  • {"criterion_text":"- Any acute, severe lupus related-flare at and during screening that needs immediate treatment other than pulse GCs and/or makes the immunosuppressive washout impossible and, thus, makes the participant ineligible for CD19 CAR-T therapy."}
  • {"criterion_text":"- Inadequate organ function during screening."}
  • {"criterion_text":"- History of, or current ECG or cardiac abnormalities indicating significant risk of safety for participants."}
  • {"criterion_text":"- Human immunodeficiency virus (HIV) positivity at screening."}
  • {"criterion_text":"- Acute or chronic infection with hepatitis B (HBV) or hepatitis C (HCV).:"}
  • {"criterion_text":"- Evidence of active or latent tuberculosis (TB) infection"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Complete renal response (CRR) at Week 52.","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Achieving DORIS defined as meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS) at Week 52 defined as in Section 8.3.1","definition_or_measurement_approach":"DORIS defined as: Clinical SLEDAI-2K of 0 at the respective timepoint AND Physician Global Assessment (PhGA) score of < 0.5 at that timepoint AND stable immunomodulatory/immunosuppressive treatment."}
  • {"endpoint_text":"- DORIS is defined as meeting the criteria of the Definition Of Remission In Systemic Lupus Erythematosus (DORIS): • Clinical SLEDAI-2K of 0 at the respective timepoint AND • Achieving a Physician Global Assessment (PhGA) score of < 0.5 at that timepoint AND • Stable immunomodulatory/immunosuppressive treatment","definition_or_measurement_approach":"DORIS defined as: Clinical SLEDAI-2K = 0 AND PhGA < 0.5 AND stable immunomodulatory/immunosuppressive treatment (per protocol Section 8.3.1)."}

Secondary endpoints

  • {"endpoint_text":"- DORIS at Week 52","definition_or_measurement_approach":"DORIS as defined in primary endpoints (SLEDAI-2K = 0, PhGA < 0.5, stable immunomodulatory/immunosuppressive therapy)."}
  • {"endpoint_text":"- Number of weeks where Lupus Low Disease Activity Score (LLDAS) was achieved until Week 52","definition_or_measurement_approach":"Count of weeks up to Week 52 during which participant met LLDAS criteria."}
  • {"endpoint_text":"- Absence of flaring (i.e., 1 new BILAG2004 A or 2 new BILAG2004 B flares) through Week 52","definition_or_measurement_approach":"Assessment of BILAG-2004 flares through Week 52 (no occurrences of 1 new A or 2 new B flares)."}
  • {"endpoint_text":"- Annualized cumulative corticosteroids dose until Week 52","definition_or_measurement_approach":"Annualized cumulative corticosteroid dose calculated through Week 52."}
  • {"endpoint_text":"- Negative serological status at Week 52","definition_or_measurement_approach":"Serological testing results at Week 52 (negative status as defined in protocol)."}
  • {"endpoint_text":"- FACIT-Fatigue score change from baseline to Week 52","definition_or_measurement_approach":"Change from baseline in FACIT-Fatigue score measured at Week 52."}
  • {"endpoint_text":"- Achieving DORIS at Week 52 and continuing to remain in remission as per the DORIS criteria.","definition_or_measurement_approach":"Achievement and maintenance of DORIS per DORIS definition at Week 52 and at subsequent timepoints."}
  • {"endpoint_text":"- Safety parameters including vital signs, adverse events, laboratory parameters and ECG evaluation","definition_or_measurement_approach":"Standard safety assessments: vital signs, AE reporting, laboratory tests and ECG evaluations as per protocol."}
  • {"endpoint_text":"- Complete renal response (CRR) at Week 52","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
73
Recruitment Window Months
66
Consent Approach
Signed informed consent must be obtained prior to participation. Consent is provided by adult participants (≥18 years). Country-specific subject information and informed consent form (ICF) documents are available in multiple languages (examples in the dossier include English, German, French, Spanish, Italian, Norwegian, Romanian, Czech, Dutch, Hungarian, Swedish, Danish, Polish). Specific ICFs and information sheets are available for pregnant participants, female partners, and parent/legal guardian information where applicable.

Geography

Total Number Of Sites
79
Total Number Of Participants
93

Norway

Earliest CTIS Part Ii Submission Date
06-02-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
369
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Oslo University Hospital HF
Department Name
2401: Department of rheumatology dermatology, and infectious disease
Contact Person Name
Øyvind Molberg
Contact Person Email
omolberg@ous-hf.no

Romania

Earliest CTIS Part Ii Submission Date
13-11-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
460
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Institutul Clinic Fundeni
Department Name
1901: Nephrology
Contact Person Name
Ismail Gener
Contact Person Email
gener732000@yahoo.com

Italy

Earliest CTIS Part Ii Submission Date
19-09-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
512
Number Of Sites
9
Number Of Participants
12

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
1210:U.O. Medicina Generale, Immunologia ed Allergologia​
Contact Person Name
Nicola Montano
Contact Person Email
Nicola.montano@unimi.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
1203: S.O.D. Clinica Medica
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
1211: S.C. Nefrologia
Contact Person Name
Marco Quaglia
Contact Person Email
marco.quaglia@ospedale.al.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
1204: U.O. Reumatologia
Contact Person Name
Carlo Selmi
Contact Person Email
carlo.selmi@humanitas.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
1202: U.O. Reumatologia
Contact Person Name
Marta Mosca
Contact Person Email
marta.mosca@med.unipi.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
1201: U.O. di Immunologia, Reumatologia, Allergologia e Malattie Rare
Contact Person Name
Lorenzo Dagna
Contact Person Email
dagna.trials@hsr.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
1209: S.C. Reumatologia
Contact Person Name
Veronica Codullo
Contact Person Email
v.codullo@smatteo.pv.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
1207: U.O. di Medicina Interna e Immunologia Dip. di Medicina Interna - DIMI
Contact Person Name
Raffaele De Palma
Contact Person Email
raffaele.depalma@unige.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
1206: U.O. di Reumatologia Dipartimento Medico
Contact Person Name
Paola Volpe
Contact Person Email
Reumatologia.pescara@asl.pe.it

Sweden

Earliest CTIS Part Ii Submission Date
04-02-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
370
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Karolinska University Hospital
Department Name
2201: Rheumatolgy
Contact Person Name
Francesca Faustini

Austria

Earliest CTIS Part Ii Submission Date
06-02-2025
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
375
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Medizinische Universitaet Innsbruck
Department Name
1806:​​Department of Internal Medicine, Clinical Division of Internal Medicine II​
Contact Person Name
​Christina Duftner​
Contact Person Email
christina.duftner@i-med.ac.at
Site Name
Medical University Of Graz
Department Name
1801: Department of Rheumatology
Contact Person Name
Jens Thiel
Contact Person Email
jens.thiel@medunigraz.at
Site Name
Medical University of Vienna
Department Name
1804: Department of Rheumatology
Contact Person Name
Paul Studenic
Contact Person Email
paul.studenic@meduniwien.it

France

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
521
Number Of Sites
24
Number Of Participants
11

Sites

Site Name
CHRU De Nancy
Department Name
1007: Medecine Interne et Immunologie Clinique
Contact Person Name
Thomas MOULINET
Contact Person Email
t.moulinet@chru-nancy.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
1011: Nephrologie et transplantation rénale
Contact Person Name
Noemie JOURDE-CHICHE
Contact Person Email
Noemie.JOURDE@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
1002: Nephrologie – Transplanation – Dialyse - Apherese
Contact Person Name
Lionel COUZI
Contact Person Email
Lionel.couzi@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux (Pessac)
Department Name
1002: Nephrologie – Transplanation – Dialyse - Apherese
Contact Person Name
Lionel COUZI
Contact Person Email
Lionel.couzi@chu-bordeaux.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
1004: Service de Medecine Interne et immunologie
Contact Person Name
Anne-Sophie KORGANOW
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
1008: Nephrologie et Immunologie Clinique
Contact Person Name
Simon VILLE
Contact Person Email
Simon.ville@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
1005: Medecine Interne
Contact Person Name
Nicolas BELHOMME
Contact Person Email
Nicolas.belhomme@chu-rennes.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
1003: Medecine Interne
Contact Person Name
Eric HACHULLA
Contact Person Email
Eric.hachulla@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
1010: Medecine Interne
Contact Person Name
Olivier FAIN
Contact Person Email
Olivier.fain@aphp.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
1006: Nephrologie et transplantation d’organes
Contact Person Name
Stanislas FAGUER
Contact Person Email
Faguer.s@chu-toulouse.fr
Site Name
Institut Paoli Calmettes
Department Name
1011: Nephrologie et transplantation rénale
Contact Person Name
Noemie JOURDE-CHICHE
Contact Person Email
Noemie.JOURDE@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
1012: Rhumatologie
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
1013: Medecine Interne
Contact Person Name
Ludovic TREFOND
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
1006: Nephrologie et transplantation d’organes
Contact Person Name
Stanislas FAGUER
Contact Person Email
Faguer.s@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris (47 Boulevard De L Hopital)
Department Name
1001: Medecine Interne 2
Contact Person Name
Zahir AMOURA
Contact Person Email
Zahir.amoura@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux (Jean Burguet)
Department Name
1002: Nephrologie – Transplanation – Dialyse - Apherese
Contact Person Name
Lionel COUZI
Contact Person Email
Lionel.couzi@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Montpellier (371 Avenue Du Doyen Gaston Giraud)
Department Name
1012: Rhumatologie
Contact Person Name
Jacques MOREL
Contact Person Email
j-morel@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Rennes (16 Boulevard De Bulgarie)
Department Name
1005: Medecine Interne
Contact Person Name
Nicolas BELHOMME
Contact Person Email
Nicolas.belhomme@chu-rennes.fr
Site Name
Centre Hospitalier Regional De Marseille (264 Rue Saint Pierre)
Department Name
1011: Nephrologie et transplantation rénale
Contact Person Name
Noemie JOURDE-CHICHE
Contact Person Email
Noemie.JOURDE@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Nantes (38 Boulevard Jean Monnet)
Department Name
1008: Nephrologie et Immunologie Clinique
Contact Person Name
Simon VILLE
Contact Person Email
Simon.ville@chu-nantes.fr
Site Name
University Hospital Of Clermont-Ferrand (58 Rue Montalembert)
Department Name
1013: Medecine Interne
Contact Person Name
Ludovic TREFOND
Site Name
Centre Hospitalier Universitaire De Toulouse (1 Avenue Du Professeur Jean Poulhes)
Department Name
1006: Nephrologie et transplantation d’organes
Contact Person Name
Stanislas FAGUER
Contact Person Email
Faguer.s@chu-toulouse.fr

Netherlands

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
525
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
1304: Nephrology
Contact Person Name
Ellen Van Ommen
Contact Person Email
Ellen.vanommen@radboudumc.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
1303: Rheumatology
Contact Person Name
Karina De Leeuw
Contact Person Email
k.de.leeuw@umcg.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
1302: Rheumatology and Clinical immunology
Contact Person Name
Helen Leavis
Contact Person Email
H.Leavis@umcutrecht.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
1301: Hematology
Contact Person Name
Joost Vermaat
Contact Person Email
j.s.p.vermaat@lumc.nl

Germany

Earliest CTIS Part Ii Submission Date
03-09-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
526
Number Of Sites
11
Number Of Participants
19

Sites

Site Name
University Hospital Cologne AöR
Department Name
1104​​:Klinik I für Innere Medizin​​
Contact Person Name
Philipp​​ Köhler​​
Contact Person Email
philipp.koehler@uk-koeln.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
1106: Zentrum fuer Innere Medizin, Innere Medizin III
Contact Person Name
Anita Viardot
Contact Person Email
anita.viardot@uniklinik-ulm.de
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
1102: Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Contact Person Name
Michaela Koehm
Site Name
Klinikum Nuernberg
Department Name
1105: Klinikum fuer Innere Medizin 5
Contact Person Name
Axel Hueber
Site Name
Robert Bosch Krankenhaus GmbH
Department Name
1112: Klinik fuer Allgemeine Innere Medizin und Nephrologie​​
Contact Person Name
Joerg Latus
Contact Person Email
Joerg.latus@rbk.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
1111: Klinik und Poliklinik fuer Endokrinologie,Nephrologie, Rheumatologie
Contact Person Name
Ulf Wagner
Site Name
Universitaetsklinikum Jena KöR
Department Name
1103: Klinik für Innere Medizin III, Rheumatologie/Osteologie
Contact Person Name
Alexander Pfeil
Site Name
Universitaetsklinikum Essen AöR
Department Name
1101: Klinik fuer Infektiologie
Contact Person Name
Sebastian Dolff
Contact Person Email
Sebastian.dolff@uk-essen.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
1115: Klinik für Rheumatologie
Contact Person Name
Jens Humrich
Contact Person Email
jens.humrich@uksh.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
1107: I. Medizinische Klinik und Poliklinik
Contact Person Name
Julia Weinmann-Menke
Site Name
Universitaetsklinikum Bonn AöR
Department Name
1109: Medizinische Klinik und Poliklinik III
Contact Person Name
Valentin Schaefer
Contact Person Email
Valentin.Schaefer@ukbonn.de

Czechia

Earliest CTIS Part Ii Submission Date
29-01-2025
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
377
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Revmatologicky Ustav
Department Name
1701: Rheumatology
Contact Person Name
Jakub Zavada
Contact Person Email
zavada@revma.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
1703: Nephrology
Contact Person Name
Zdenka Hruskova
Contact Person Email
zdenka.hruskova@vfn.cz
Site Name
University Hospital Olomouc
Department Name
1702: Nephrology
Contact Person Name
Karel Krejci
Contact Person Email
karel.krejci@fnol.cz

Denmark

Earliest CTIS Part Ii Submission Date
21-01-2025
Latest Decision Or Authorization Date
09-02-2026
Processing Time Days
384
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Aarhus University Hospital
Department Name
2101: Afdeling for Nyresygdomme
Contact Person Name
Per Ramløv Ivarsen
Contact Person Email
perivars@rm.dk

Hungary

Earliest CTIS Part Ii Submission Date
24-02-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
354
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
University Of Debrecen
Department Name
2002: Department of Internal Medicine
Contact Person Name
Arpad Illes
Contact Person Email
llesarpaddr@gmail.com
Site Name
Semmelweis University
Department Name
2001: Department of Rheumatology and Immunology
Contact Person Name
Gyorgy Nagy
Contact Person Email
gyorgyngy@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
27-04-2026
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
14
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
2502: Oddział Kliniczny Nefrologii, Transplantologii i Chorób Wewnętrznych
Contact Person Name
Krzysztof Pawlaczyk
Contact Person Email
kpawlac@ump.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
2501:Oddział Hematologii, Transplantologii i Chorób Wewnętrznych - Klinika Hematologii
Contact Person Name
Michał Nowicki
Contact Person Email
michal.nowicki@umed.lodz.p
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu (Augustyna Szamarzewskiego 84)
Department Name
2502:Katedra i Klinika Hematologii i Transplantacji Szpiku
Contact Person Name
Krzysztof Pawlaczyk
Contact Person Email
kpawlaczyk@ump.edu.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
2501:Klinika Nefrologii, Hipertensjologii, Transplantologii i Chorób Wewnętrznych
Contact Person Name
Michał Nowicki
Contact Person Email
michal.nowicki@umed.lodz.pl

Spain

Earliest CTIS Part Ii Submission Date
06-09-2024
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
552
Number Of Sites
15
Number Of Participants
15

Sites

Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
1411: Nefrología
Contact Person Name
José María Mora Gutierrez
Contact Person Email
jmora@unav.es
Site Name
Hospital Universitario De Salamanca
Department Name
1408: Reumatología
Contact Person Name
Susana Gómez Castro
Contact Person Email
sgomezc@saludcastillayleon.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
1411: Nefrología
Contact Person Name
José María Mora Gutierrez
Contact Person Email
jmora@unav.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
1403: Reumatología
Contact Person Name
Eva Maria Pampin Perez
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
1402: Reumatología
Contact Person Name
Josefina Cortés Hernández
Contact Person Email
fina.cortes@vhir.org
Site Name
Complexo Hospitalario Universitario De Vigo
Department Name
1410: Reumatologia
Contact Person Name
José María Pego Reigosa
Site Name
Hospital Universitario 12 De Octubre
Department Name
1405: Reumatología
Contact Person Name
María Galindo Izquierdo
Contact Person Email
mgalindo@h12o.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
1406: Reumatología
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
1409: Reumatología
Contact Person Name
José Andrés Román Ivorra
Contact Person Email
roman_jan@gva.es
Site Name
Hospital Universitario Reina Sofia
Department Name
1407: Reumatología
Contact Person Name
Alejandro Escudero Contreras
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
1404: Reumatología
Contact Person Name
José María Álvaro Gracia
Site Name
Bellvitge University Hospital
Department Name
1401: Reumatología
Contact Person Name
Francisco Javier Narváez García
Site Name
Hospital Universitario Marques De Valdecilla (duplicate listing)
Department Name
1406: Reumatología
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Hospital Universitario De Salamanca (duplicate listing)
Department Name
1408: Reumatología
Contact Person Name
Susana Gómez Castro
Contact Person Email
sgomezc@saludcastillayleon.es
Site Name
Hospital Universitario De Vigo (duplicate listing)
Department Name
1410: Reumatologia
Contact Person Name
José María Pego Reigosa

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
Disease Activity Data Monitoring; (other IQVIA entries provide clinical trial services / EU clinical trials information).
Name
Parexel International (IRL) Limited
Responsibilities
Clinical trial services; ancillary supplies for leukapheresis and infusion (separate entries).
Name
Syneos Health Inc.
Name
Icon Clinical Research Limited
Name
Veeda Clinical Research Limited
Responsibilities
PK (Fludarabine) analysis

Third parties

  • {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"Genetic assessment","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient retention; hotel and travel reimbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Clinigma ApS","duties_or_roles":"Patient experience exit interview","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Disease Activity Data Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Aliquoting","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"Transcriptomics (incl. B cell repertoire)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clinical Ink Inc.","duties_or_roles":"Electronic Clinical Outcome Assessments (eCOA, ePRO, ClinRO)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Pharmacokinetics (PK) IG (Cellular) analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient facing materials (informative videos, print material), Site training materials","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (additional entry)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Electrocardiogram (ECG)","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited (third entry)","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"PK (Fludarabine) analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"SGS France","duties_or_roles":"Urine biomarkers","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited (additional entry)","duties_or_roles":"Ancillary supplies for leukapheresis and infusion","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"PK Analysis","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
YTB323
Active Substance
RAPCABTAGENE AUTOLEUCEL
Modality
Cell therapy
Routes Of Administration
Intravenous use
Route
Intravenous
Authorisation Status
Investigational (no marketing authorisation specified)
Starting Dose
12.5 x 10^6 CAR-positive viable T cells (single infusion)
Frequency
Single infusion
Combination Treatment
Yes

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