Clinical trial • Phase II • Immunology|Rare Disease

RAPCABTAGENE AUTOLEUCEL for Idiopathic inflammatory myopathies (severe refractory) | Immune-mediated myositis

Phase II trial of RAPCABTAGENE AUTOLEUCEL for Idiopathic inflammatory myopathies (severe refractory) | Immune-mediated myositis.

Overview

Trial Therapeutic Area
Immunology|Rare Disease
Trial Disease
Idiopathic inflammatory myopathies (severe refractory) | Immune-mediated myositis
Trial Stage
Phase II
Drug Modality
Cell therapy|Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
29-08-2024
First CTIS Authorization Date
20-12-2024

Trial design

Randomised, open-label, investigator's choice of treatment (comparator arm). comparator products listed in part i include: mycophenolate mofetil (oral, hard capsules), cyclophosphamide (powder for solution for injection/infusion, iv), mycophenolic acid (gastro-resistant tablet, oral), tacrolimus (capsule, oral), rituximab (concentrate for infusion, iv). dose and schedule details are not specified in the provided ctis json.-controlled Phase II trial in Germany, Spain, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator's choice of treatment (comparator arm). Comparator products listed in Part I include: MYCOPHENOLATE MOFETIL (oral, hard capsules), CYCLOPHOSPHAMIDE (powder for solution for injection/infusion, IV), MYCOPHENOLIC ACID (gastro-resistant tablet, oral), TACROLIMUS (capsule, oral), RITUXIMAB (concentrate for infusion, IV). Dose and schedule details are not specified in the provided CTIS JSON.
Target Sample Size
45
Trial Duration For Participant
364

Eligibility

Recruits 45 The application indicates isVulnerablePopulationSelected = true. Signed informed consent must be obtained prior to participation in the study. Subject information and informed consent forms (L1_ICF) and procedure documents (L2_ICF) are provided for adults in multiple languages (see documents: German, English, Spanish, French, Italian, Dutch). There are also specific follow-up ICFs for pregnant participants and for pregnant partners/parent legal guardian information sheets, indicating additional procedures for pregnant participants or partners; consent is required from the participant (or legal guardian where applicable) per the provided ICFs..

Vulnerable Population
The application indicates isVulnerablePopulationSelected = true. Signed informed consent must be obtained prior to participation in the study. Subject information and informed consent forms (L1_ICF) and procedure documents (L2_ICF) are provided for adults in multiple languages (see documents: German, English, Spanish, French, Italian, Dutch). There are also specific follow-up ICFs for pregnant participants and for pregnant partners/parent legal guardian information sheets, indicating additional procedures for pregnant participants or partners; consent is required from the participant (or legal guardian where applicable) per the provided ICFs.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study"}
  • {"criterion_text":"- Male or female participants xx on the day of signing informed consent."}
  • {"criterion_text":"- A diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria."}
  • {"criterion_text":"- Participant must be xx based on an historical result xx"}
  • {"criterion_text":"- Participants must have refractory xx:a. xx b. xx i. xx ii.xx iii. Xx iv. xx xx"}
  • {"criterion_text":"- Diagnosed with active disease such as presence of at least 1 of the following criteria and confirmed by an adjudication committee for criteria b through e prior to randomization: xx"}
  • {"criterion_text":"- (any additional inclusion lines present as 'xx' placeholders in the source)"}

Exclusion criteria

  • {"criterion_text":"- Have severe muscle damage at Screening, as defined xx"}
  • {"criterion_text":"- Participants treated with RTX xx prior to Screening or CYC xx prior to Baseline."}
  • {"criterion_text":"- Inadequate organ function (one retest during Screening of any of the below is permitted): Inadequate renal function (performed by central laboratory) defined as: • eGFR < 45 ml/min/1.73m2 using the 2021 CKD-EPI formula. Inadequate hepatic function defined as any of the following: • ALT and AST >1.5 × ULN (performed by central laboratory), except if clinically assessed as secondary to IIM • Total Bilirubin >1.5 × ULN (performed by central laboratory). Participants with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 × ULN and direct bilirubin ≤1.5 × ULN. • International normalized ratio (INR) >1.5 (performed by central laboratory) Inadequate cardiac function defined as: • Left ventricular ejection fraction (LVEF) <50% as determined by echocardiogram (ECHO) Inadequate hematologic function (performed by central laboratory) defined as: • Absolute neutrophil count (ANC) <1500/mm3 • Platelets <100,000/μL • White blood cells count (WBC) <3,000 cells/μL • Absolute lymphocyte count <700/μL • Hemoglobin < 8.0 g/dL (< 4.9 mmol/L) Inadequate pulmonary function defined by ANY of the following: • Oxygen saturation measured by pulse xx • Hemoglobin corrected DLCO xx • FVC% xx"}
  • {"criterion_text":"- Any participant who failed all available treatment options in the comparator arm or for whom these options are clinically inappropriate in the opinion of the Investigator."}
  • {"criterion_text":"- Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol (e.g., rapcabtagene autoleucel, comparator arm treatments, tocilizumab, xx, etc.), to the excipients of rapcabtagene autoleucel (e.g., xx), or to any other drug product as advised for administration in the study protocol (e.g., xx, G-CSF , tocilizumab)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achieving moderate to major improvement in TIS (TIS ≥ 40) at Week 52 (Yes/No)","definition_or_measurement_approach":"Total Improvement Score (TIS); moderate to major improvement defined as TIS ≥ 40 at Week 52 (binary Yes/No)"}

Secondary endpoints

  • {"endpoint_text":"- Achieving moderate to major improvement in TIS (≥ 40) at Week 52 (Yes/No)","definition_or_measurement_approach":"Total Improvement Score (TIS); improvement defined as TIS ≥ 40 at Week 52 (binary Yes/No)"}
  • {"endpoint_text":"- Adjusted annual cumulative GC dose up to Week 52","definition_or_measurement_approach":"Cumulative glucocorticoid (GC) dose from baseline to Week 52, adjusted annualised dose (measurement of cumulative GC exposure)"}
  • {"endpoint_text":"- Change from baseline in percent predicted Forced Vital Capacity (FVC%) at Week 52","definition_or_measurement_approach":"Change from baseline in percent predicted Forced Vital Capacity (FVC%) measured at Week 52"}
  • {"endpoint_text":"- Achieving major improvement in TIS (≥ 60) at Week 52 (Yes/No)","definition_or_measurement_approach":"Total Improvement Score (TIS); major improvement defined as TIS ≥ 60 at Week 52 (binary Yes/No)"}
  • {"endpoint_text":"- Change from baseline in Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue 7a at Week 52","definition_or_measurement_approach":"Change from baseline in PROMIS-Fatigue 7a score at Week 52 (patient-reported outcome measure)"}
  • {"endpoint_text":"- Safety parameters include vital signs, adverse events, laboratory parameters and ECG evaluation","definition_or_measurement_approach":"Safety assessed by monitoring vital signs, recording adverse events, laboratory parameter results and ECG evaluations"}

Recruitment

Planned Sample Size
45
Recruitment Window Months
94
Consent Approach
Signed informed consent must be obtained prior to participation. Subject information and consent documents (L1_ICF, L2_ICF and additional info sheets) are available in multiple languages (documents present for German, English, Spanish, French, Italian, Dutch). Specific ICFs and follow-up sheets are provided for pregnant participants, pregnant partners and for female partners, and there are addenda/optional ICFs and biomarker information sheets as indicated in the uploaded documents.

Geography

Total Number Of Sites
37
Total Number Of Participants
45

Germany

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
514
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
#3106: Klinik für Innere Medizin III, Rheumatologie/Osteologie
Principal Investigator Name
Alexander Pfeil
Principal Investigator Email
Alexander.Pfeil@med.uni-jena.de
Contact Person Name
Alexander Pfeil
Site Name
Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Department Name
#3104: Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
Principal Investigator Name
Michaela Koehm
Principal Investigator Email
michaela.koehm@itmp.fraunhofer.de
Contact Person Name
Michaela Koehm
Site Name
Universitaetsklinikum Aachen AöR
Department Name
#3101: Medizinische Klinik II, Sektion Rheumatologie
Principal Investigator Name
Thomas Rauen
Principal Investigator Email
trauen@ukaachen.de
Contact Person Name
Thomas Rauen
Contact Person Email
trauen@ukaachen.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
#3108: Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatolgie
Principal Investigator Name
Ulf Wagner
Principal Investigator Email
Ulf.Wagner@medizin.uni-leipzig.de
Contact Person Name
Ulf Wagner
Site Name
University Hospital Cologne AöR
Department Name
#3107: 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
Universitaetsklinikum Ulm AöR
Department Name
#3112: 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
Klinikum Nuernberg
Department Name
#3111: Klinikum für Innere Medizin 5 Schwerpunkt Onkologie / Hämatologie
Principal Investigator Name
Axel Hueber
Principal Investigator Email
Axel.Hueber@klinikum-nuernberg.de
Contact Person Name
Axel Hueber
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
3113: Klinik für Rheumatologie
Principal Investigator Name
Gabriela Riemekasten
Principal Investigator Email
gabriela.riemekasten@uksh.de
Contact Person Name
Gabriela Riemekasten
Contact Person Email
gabriela.riemekasten@uksh.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#3105: III. Medizinische Klinik und Poliklinik Nephrologie, Rheumatologie und Endokrinologie
Principal Investigator Name
Martin Krusche
Principal Investigator Email
m.krusche@uke.de
Contact Person Name
Martin Krusche
Contact Person Email
m.krusche@uke.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
#3109: 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

Spain

Earliest CTIS Part Ii Submission Date
22-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
514
Number Of Sites
11
Number Of Participants
12

Sites

Site Name
Clinica Universidad De Navarra
Department Name
#3410:Nefrología
Principal Investigator Name
Jose Maria Mora Gutierrez
Principal Investigator Email
jmora@unav.es
Contact Person Name
Jose Maria Mora Gutierrez
Contact Person Email
jmora@unav.es
Site Name
Hospital Universitario Reina Sofia
Department Name
#3407:Reumatología
Principal Investigator Name
Alejandro Escudero Contreras
Contact Person Name
Alejandro Escudero Contreras
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
#3403:Reumatología
Principal Investigator Name
Eva María Pérez Pampín
Principal Investigator Email
eva.perez.pampin@sergas.es
Contact Person Name
Eva María Pérez Pampín
Contact Person Email
eva.perez.pampin@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
#3406:Reumatología
Principal Investigator Name
Ricardo Blanco Alonso
Principal Investigator Email
ricardo.blanco@scsalud.es
Contact Person Name
Ricardo Blanco Alonso
Contact Person Email
ricardo.blanco@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
#3402:Medicina Interna
Principal Investigator Name
Albert Selva O’Callaghan
Principal Investigator Email
albert.selva@vallhebron.cat
Contact Person Name
Albert Selva O’Callaghan
Contact Person Email
albert.selva@vallhebron.cat
Site Name
Hospital Universitario De Salamanca
Department Name
#3408:Reumatología
Principal Investigator Name
Susana Gómez Castro
Principal Investigator Email
sgomezc@saludcastillayleon.es
Contact Person Name
Susana Gómez Castro
Contact Person Email
sgomezc@saludcastillayleon.es
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
#3404:Reumatología
Principal Investigator Name
José María Álvaro Gracia
Principal Investigator Email
josemaria.alvarogracia@salud.madrid.org
Contact Person Name
José María Álvaro Gracia
Site Name
Bellvitge University Hospital
Department Name
#3401:Reumatología
Principal Investigator Name
Francisco Javier Narváez García
Principal Investigator Email
fjnarvaez@bellvitgehospital.cat
Contact Person Name
Francisco Javier Narváez García
Site Name
Hospital Universitario 12 De Octubre
Department Name
#3405:Reumatología
Principal Investigator Name
Patricia Esmeralda Carreira Delgado
Principal Investigator Email
carreira@h12o.es
Contact Person Name
Patricia Esmeralda Carreira Delgado
Contact Person Email
carreira@h12o.es
Site Name
Clinica Universidad De Navarra (Madrid site)
Department Name
#3410:Nefrología
Principal Investigator Name
Jose Maria Mora Gutierrez
Principal Investigator Email
jmora@unav.es
Contact Person Name
Jose Maria Mora Gutierrez
Contact Person Email
jmora@unav.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
#3409:Reumatología
Principal Investigator Name
Natalia Mena Vázquez
Principal Investigator Email
natalia.mena.sspa@juntadeandalucia.es
Contact Person Name
Natalia Mena Vázquez

France

Earliest CTIS Part Ii Submission Date
06-12-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
500
Number Of Sites
7
Number Of Participants
9

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
#3002: Medecine Interne
Principal Investigator Name
Eric HACHULLA
Principal Investigator Email
Eric.hachulla@chru-lille.fr
Contact Person Name
Eric HACHULLA
Contact Person Email
Eric.hachulla@chru-lille.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
#3009: Medecine Interne
Principal Investigator Name
Nicolas SCHLEINITZ
Principal Investigator Email
Nicolas.SCHLEINITZ@ap-hm.fr
Contact Person Name
Nicolas SCHLEINITZ
Contact Person Email
Nicolas.SCHLEINITZ@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
#3005: Medecine Interne
Principal Investigator Name
Eric MENSI
Principal Investigator Email
Eric.MENSI@chu-rennes.fr
Contact Person Name
Eric MENSI
Contact Person Email
Eric.MENSI@chu-rennes.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
#3008: Rhumatologie
Principal Investigator Name
Dewi GUELLEC
Principal Investigator Email
Dewi.guellec@chu-brest.fr
Contact Person Name
Dewi GUELLEC
Contact Person Email
Dewi.guellec@chu-brest.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#3001: Medecine Interne et Immunologie clinique
Principal Investigator Name
Yves ALLENBACH
Principal Investigator Email
yves.allenbach@aphp.fr
Contact Person Name
Yves ALLENBACH
Contact Person Email
yves.allenbach@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
#3007: Medecine Interne
Principal Investigator Name
Laure GALLAY
Principal Investigator Email
laure.gallay01@chu-lyon.fr
Contact Person Name
Laure GALLAY
Contact Person Email
laure.gallay01@chu-lyon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
#3003: Rhumatologie
Principal Investigator Name
Alain MEYER
Principal Investigator Email
Alain.meyer@chru-strasbourg.fr
Contact Person Name
Alain MEYER
Contact Person Email
Alain.meyer@chru-strasbourg.fr

Netherlands

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
493
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
#3302:Internal Medicine
Principal Investigator Name
Zana Brkic
Principal Investigator Email
z.brkic@erasmusmc.nl
Contact Person Name
Zana Brkic
Contact Person Email
z.brkic@erasmusmc.nl
Site Name
Amsterdam UMC Stichting
Department Name
#3301: Neurology
Principal Investigator Name
Joost Raaphorst
Principal Investigator Email
j.raaphorst@amsterdamumc.nl
Contact Person Name
Joost Raaphorst
Contact Person Email
j.raaphorst@amsterdamumc.nl

Italy

Earliest CTIS Part Ii Submission Date
19-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
517
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
3207:S.O.D. Clinica Medica
Principal Investigator Name
Gianluca Moroncini
Principal Investigator Email
g.moroncini@staff.univpm.it
Contact Person Name
Gianluca Moroncini
Contact Person Email
g.moroncini@staff.univpm.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
#3201: U.O.C. Reumatologia e Immunologia Clinica
Principal Investigator Name
Paola Toniati
Principal Investigator Email
palola1@virgilio.it
Contact Person Name
Paola Toniati
Contact Person Email
palola1@virgilio.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
#3202: U.O.C. di Reumatologia
Principal Investigator Name
Giovanni Orsolini
Principal Investigator Email
giovanniorsolini@gmail.com
Contact Person Name
Giovanni Orsolini
Contact Person Email
giovanniorsolini@gmail.com
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
#3204: Medicina Generale - Immunologia e Allergologia
Principal Investigator Name
Nicola Montano
Principal Investigator Email
nicola.montano@policlinico.mi.it
Contact Person Name
Nicola Montano
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
#3203: SSD Reumatologia
Principal Investigator Name
Carlo Alberto Scirè
Principal Investigator Email
carlo.scire@unimib.it
Contact Person Name
Carlo Alberto Scirè
Contact Person Email
carlo.scire@unimib.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
3206: Epis S.C. Reumatologia
Principal Investigator Name
Oscar Massimiliano Epis
Principal Investigator Email
oscar.epis@ospedaleniguarda.it
Contact Person Name
Oscar Massimiliano Epis
Contact Person Email
oscar.epis@ospedaleniguarda.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
3205:U.O. Reumatologia ed Immunologia
Principal Investigator Name
Carlo Selmi
Principal Investigator Email
carlo.selmi@humanitas.it
Contact Person Name
Carlo Selmi
Contact Person Email
carlo.selmi@humanitas.it

Sponsor

Primary sponsor

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

Contract research organisations

Name
PAREXEL International GmbH
Responsibilities
Ancillary supplies for infusion
Name
Parexel International (IRL) Limited
Name
Icon Clinical Research Limited
Name
Syneos Health Inc.
Name
IQVIA Limited
Name
Iqvia Biotech LLC
Responsibilities
Site support
Name
Veeda Clinical Research Limited

Third parties

  • {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cristcot HCA LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO/eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"GuruKool LLC","duties_or_roles":"Rater’s trainings","organisation_type":"SME"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local drug supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Travel concierge and patient re-imbursement","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"Ancillary supplies for infusion","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rules Based Medicine Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"Site support","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Diagnostic Services Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"eResearchTechnology GmbH","duties_or_roles":"Spirometry review, ECG central reading and storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging storage and reading – HRCT scans","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Patient facing materials (videos, print material)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Clinigma ApS","duties_or_roles":"In-trial interviews","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Irepertoire Inc.","duties_or_roles":"","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
MYCOPHENOLATE MOFETIL
Active Substance
MYCOPHENOLATE MOFETIL
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE / IV INFUSION
Route
INTRAVENOUS USE
Authorisation Status
2
Investigational Product Name
TACROLIMUS
Active Substance
TACROLIMUS
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
2
Investigational Product Name
RITUXIMAB
Active Substance
RITUXIMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
2
Orphan Designation
Yes
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
MYCOPHENOLIC ACID
Active Substance
MYCOPHENOLIC ACID
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
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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