Clinical trial • Phase III • Oncology|Rare Disease
CILTACABTAGENE AUTOLEUCEL for Multiple myeloma (relapsed; lenalidomide-refractory)
Phase III trial of CILTACABTAGENE AUTOLEUCEL for Multiple myeloma (relapsed; lenalidomide-refractory).
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Multiple myeloma (relapsed; lenalidomide-refractory)
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy|Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 13-02-2024
- First CTIS Authorization Date
- 21-03-2024
Trial design
Randomised, pomalidomide + bortezomib + dexamethasone (pvd) or daratumumab + pomalidomide + dexamethasone (dpd) (doses/schedules not specified in provided data)-controlled, crossover Phase III trial across 39 sites in Greece, Netherlands, Italy and others.
- Randomised
- Yes
- Comparator
- Pomalidomide + Bortezomib + Dexamethasone (PVd) or Daratumumab + Pomalidomide + Dexamethasone (DPd) (doses/schedules not specified in provided data)
- Crossover
- Yes
- Target Sample Size
- 164
Eligibility
Recruits 164 Vulnerable population flag selected. All participants must be adults (≥18 years). Informed consent is documented using Subject Information Sheets (SIS) and Informed Consent Forms (ICF); multiple language versions and addenda are provided (including addenda for crossover, pregnant partner, pregnant patient, privacy for child exposed to IP). Specific ICFs and wallet cards are listed for different arms and countries, indicating tailored consent materials and procedures..
- Vulnerable Population
- Vulnerable population flag selected. All participants must be adults (≥18 years). Informed consent is documented using Subject Information Sheets (SIS) and Informed Consent Forms (ICF); multiple language versions and addenda are provided (including addenda for crossover, pregnant partner, pregnant patient, privacy for child exposed to IP). Specific ICFs and wallet cards are listed for different arms and countries, indicating tailored consent materials and procedures.
Inclusion criteria
- {"criterion_text":"-Be at least 18 years of age."}
- {"criterion_text":"-Have documented diagnosis of MM as defined by the criteria below:-Multiple myeloma diagnosis according to the IMWG diagnostic criteria -Measurable disease at screening"}
- {"criterion_text":"-Have received 1 to 3 prior lines of therapy including a PI and IMiD. Subject must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy"}
- {"criterion_text":"-Have documented evidence of PD by IMWG criteria based on investigator's determination on or within 6 months of their last regimen."}
- {"criterion_text":"-Subjects with only 1 prior line of therapy must have progressed within 36 months of a stem cell transplant or if not transplanted, then within 42 months of starting initial therapy."}
- {"criterion_text":"-Be refractory to lenalidomide per IMWG consensus guidelines in at least one prior line of therapy."}
- {"criterion_text":"-Have an ECOG Performance Status score of 0 or 1"}
- {"criterion_text":"-Have clinical laboratory values as specified in the protocol. For additional information see section 5.1 of the protocol"}
Exclusion criteria
- {"criterion_text":"-Prior treatment with CAR-T therapy directed at any target."}
- {"criterion_text":"-Stroke or seizure within 6 months of signing ICF."}
- {"criterion_text":"-Received either of the following:-An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graftversus-host disease. Subjects with active graft-versus-host disease are excluded.-An autologous stem cell transplantation ≤ 12 weeks before apheresis."}
- {"criterion_text":"-Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. For additional information, see section 5.2 of the protocol"}
- {"criterion_text":"-Any previous therapy that is targeted to BCMA."}
- {"criterion_text":"-Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia."}
- {"criterion_text":"-Subjects with ongoing peripheral neuropathy may be limited to DPd as standard therapy or bridging therapy"}
- {"criterion_text":"-Was vaccinated with live attenuated vaccines within 6 weeks prior to randomization"}
- {"criterion_text":"-Subject received any antitumor therapy as specified in the protocol, prior to randomization"}
- {"criterion_text":"-Active malignancies other than the disease being treated under study. Refer to the protocol for allowed exceptions."}
- {"criterion_text":"-Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis."}
- {"criterion_text":"-Contraindications or life-threatening allergies, hypersensitivity, or intolerance to cilta-cel or its excipients, including dimethylsulfoxide, or to fludarabine, cyclophosphamide, tocilizumab, pomalidomide, dexamethasone.- Subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to daratumumab will not be permitted to receive DPd as standard therapy or bridging therapy; however, subjects may receive PVd as standard therapy or bridging therapy. Likewise, subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib will not be permitted to receive PVd as standard therapy or bridging therapy; but may receive DPd as standard therapy or bridging therapy."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Progression-free survival (PFS)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 164
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent obtained from adult participants using subject information sheets and informed consent forms (SIS and ICF). Multiple language versions and specific addenda (e.g. crossover, OOS addenda, pregnant partner, privacy for child exposed to IP) are provided per country. Contact details and CTIS point-of-contact are provided in sponsor contact documents.
Geography
- Total Number Of Sites
- 39
- Total Number Of Participants
- 233
Greece
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 02-05-2024
- Processing Time Days
- 65
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Dept of Internal Medicine, Division of Hematology
- Principal Investigator Name
- Evangelos Terpos
- Principal Investigator Email
- eterpos@med.uoa.gr
- Contact Person Name
- Evangelos Terpos
- Contact Person Email
- eterpos@med.uoa.gr
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematologie
- Principal Investigator Name
- Annemiek Broijl
- Principal Investigator Email
- a.broyl@erasmusmc.nl
- Contact Person Name
- Annemiek Broijl
- Contact Person Email
- a.broyl@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Hematologie
- Principal Investigator Name
- Wilfried Roeloffzen
- Principal Investigator Email
- w.w.h.roeloffzen@umcg.nl
- Contact Person Name
- Wilfried Roeloffzen
- Contact Person Email
- w.w.h.roeloffzen@umcg.nl
- Site Name
- Amsterdam UMC
- Department Name
- Hematologie
- Principal Investigator Name
- Niels van de Donk
- Principal Investigator Email
- N.vandeDonk@amsterdamumc.nl
- Contact Person Name
- Niels van de Donk
- Contact Person Email
- N.vandeDonk@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematologie
- Principal Investigator Name
- Monique Minnema
- Principal Investigator Email
- hematologie@umcutrecht.nl
- Contact Person Name
- Monique Minnema
- Contact Person Email
- hematologie@umcutrecht.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Valerio De Stefano
- Principal Investigator Email
- valerio.DeStefano@unicatt.it
- Contact Person Name
- Valerio De Stefano
- Contact Person Email
- valerio.DeStefano@unicatt.it
- Site Name
- Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
- Department Name
- Dipartimento Biotecnologie Molecolari e Scienze per la Salute-SC Ematologia U-Università Torino
- Principal Investigator Name
- Francesca Gay
- Principal Investigator Email
- francesca.gay@unito.it
- Contact Person Name
- Francesca Gay
- Contact Person Email
- francesca.gay@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Dipartimento Malattie Oncologiche ed Ematologiche
- Principal Investigator Name
- Elena Zamagni
- Principal Investigator Email
- e.zamagni@unibo.it
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dipartimento Onco-emtaologia Unità di Ematologia e Trapianto Midollo Osseo
- Principal Investigator Name
- Fabio Ciceri
- Principal Investigator Email
- ciceri.clinicaltrials@hsr.it
- Contact Person Name
- Fabio Ciceri
- Contact Person Email
- ciceri.clinicaltrials@hsr.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Dipartimento di Oncologia Medica ed Ematologia - SC Ematologia
- Principal Investigator Name
- Paolo Corradini
- Principal Investigator Email
- paolo.coradini@unimi.it
- Contact Person Name
- Paolo Corradini
- Contact Person Email
- paolo.coradini@unimi.it
Sweden
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 26-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematologiska kliniken
- Principal Investigator Name
- Stina Wichert
- Principal Investigator Email
- stina.wichert@med.lu.se
- Contact Person Name
- Stina Wichert
- Contact Person Email
- stina.wichert@med.lu.se
- Site Name
- Uppsala University Hospital
- Department Name
- KFUE, Blod- och tumörsjukdomar
- Principal Investigator Name
- Kristina Carlson
- Principal Investigator Email
- kristina.carlson@akademiska.se
- Contact Person Name
- Kristina Carlson
- Contact Person Email
- kristina.carlson@akademiska.se
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 04-04-2024
- Processing Time Days
- 37
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- CHU De Liege
- Department Name
- Hematologie
- Principal Investigator Name
- Jo Caers
- Principal Investigator Email
- jo.caers@chu.ulg.ac.be
- Contact Person Name
- Jo Caers
- Contact Person Email
- jo.caers@chu.ulg.ac.be
- Site Name
- Universiteit Gent
- Department Name
- Hematologie
- Principal Investigator Name
- Tessa Kerre
- Principal Investigator Email
- tessa.kerre@uzgent.be
- Contact Person Name
- Tessa Kerre
- Contact Person Email
- tessa.kerre@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Hematologie
- Principal Investigator Name
- Michel Delforge
- Principal Investigator Email
- michel.delforge@uzleuven.be
- Contact Person Name
- Michel Delforge
- Contact Person Email
- michel.delforge@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Hematologie
- Principal Investigator Name
- Sébastien Anguille
- Principal Investigator Email
- sebastien.anguille@uza.be
- Contact Person Name
- Sébastien Anguille
- Contact Person Email
- sebastien.anguille@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 27-03-2024
- Processing Time Days
- 29
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service hématologie
- Principal Investigator Name
- Pierre BORIES
- Principal Investigator Email
- bories.pierre@iuct-oncopole.fr
- Contact Person Name
- Pierre BORIES
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service hématologie
- Principal Investigator Name
- Philippe MOREAU
- Principal Investigator Email
- philippe.moreau@chu-nantes.fr
- Contact Person Name
- Philippe MOREAU
- Contact Person Email
- philippe.moreau@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Hématologie et Thérapie Cellulaire, Pôle Régional de Cancérologie
- Principal Investigator Name
- Xavier LELEU
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier LELEU
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Hopital Huriez - Service Hématologie
- Principal Investigator Name
- Salomon MANIER
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Centre Hospitalier Lyon Sud - Service d’Hématologie Clinique
- Principal Investigator Name
- Lionel KARLIN
- Principal Investigator Email
- lionel.karlin@chu-lyon.fr
- Contact Person Name
- Lionel KARLIN
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital Saint-Louis Service Immuno-hématologie
- Principal Investigator Name
- Bertrand ARNULF
- Principal Investigator Email
- bertrand.arnulf@aphp.fr
- Contact Person Name
- Bertrand ARNULF
- Contact Person Email
- bertrand.arnulf@aphp.fr
Denmark
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Rigshospitalet
- Department Name
- Dept of Hematology/Clinical trial unit 2081
- Principal Investigator Name
- Anne Mylin
- Principal Investigator Email
- anne.kaersgaard.mylin@regionh.dk
- Contact Person Name
- Anne Mylin
- Contact Person Email
- anne.kaersgaard.mylin@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 21-03-2024
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abt. fuer Innere Medizin II, Haematologie, Onkologie, Rheumatologie
- Principal Investigator Name
- Britta Besemer
- Principal Investigator Email
- britta.besemer@med.uni-tuebingen.de
- Contact Person Name
- Britta Besemer
- Contact Person Email
- britta.besemer@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II, Abt. fuer Onkologie, Haematologie
- Principal Investigator Name
- Martin Kortuem
- Principal Investigator Email
- kortuem_m@ukw.de
- Contact Person Name
- Martin Kortuem
- Contact Person Email
- kortuem_m@ukw.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik 1 Innere Medizin, Studienzentrum Haematologie, Onkologie
- Principal Investigator Name
- Christoph Scheid
- Principal Investigator Email
- c.scheid@uni-koeln.de
- Contact Person Name
- Christoph Scheid
- Contact Person Email
- c.scheid@uni-koeln.de
- Site Name
- Technische Universitat Dresden
- Department Name
- Med. Klinik und Poliklinik 1, Haematologische Ambulanz MK1-A1
- Principal Investigator Name
- Malte von Bonin
- Principal Investigator Email
- malte.bonin@uniklinikum-dresden.de
- Contact Person Name
- Malte von Bonin
- Contact Person Email
- malte.bonin@uniklinikum-dresden.de
Spain
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 26-03-2024
- Processing Time Days
- 28
- Number Of Sites
- 8
- Number Of Participants
- 82
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Albert Oriol Rocafiguera
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol Rocafiguera
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Principal Investigator Name
- Carlos Fernandez de Larrea
- Principal Investigator Email
- cfernan1@clinic.cat
- Contact Person Name
- Carlos Fernandez de Larrea
- Contact Person Email
- cfernan1@clinic.cat
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Jesus San Miguel Izquierdo
- Principal Investigator Email
- sanmiguel@unav.es
- Contact Person Name
- Jesus San Miguel Izquierdo
- Contact Person Email
- sanmiguel@unav.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Principal Investigator Name
- Juan Luis Reguera Ortega
- Principal Investigator Email
- juanlu_jlr@hotmail.com
- Contact Person Name
- Juan Luis Reguera Ortega
- Contact Person Email
- juanlu_jlr@hotmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematology
- Principal Investigator Name
- Mi Kwon
- Principal Investigator Email
- mi.kwon@salud.madrid.org
- Contact Person Name
- Mi Kwon
- Contact Person Email
- mi.kwon@salud.madrid.org
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Maria Victoria Mateos Manteca
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- Maria Victoria Mateos Manteca
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario Virgen Del Rocio (duplicate listing resolved above)
- Department Name
- Hematology
Poland
- Earliest CTIS Part Ii Submission Date
- 27-02-2024
- Latest Decision Or Authorization Date
- 15-04-2024
- Processing Time Days
- 48
- Number Of Sites
- 4
- Number Of Participants
- 24
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Hematology
- Principal Investigator Name
- Magdalena Dutka
- Principal Investigator Email
- dmag77@gumed.edu.pl
- Contact Person Name
- Magdalena Dutka
- Contact Person Email
- dmag77@gumed.edu.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Hematology
- Principal Investigator Name
- Sebastian Giebel
- Principal Investigator Email
- Sebastian.Giebel@io.gliwice.pl
- Contact Person Name
- Sebastian Giebel
- Contact Person Email
- Sebastian.Giebel@io.gliwice.pl
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Hematology
- Principal Investigator Name
- Ewa Lech-Maranda
- Principal Investigator Email
- emaranda@ihit.waw.pl
- Contact Person Name
- Ewa Lech-Maranda
- Contact Person Email
- emaranda@ihit.waw.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Hematology
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- dytfeld@me.com
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Iqvia Rds Inc.
- Responsibilities
- sponsorDuties code: 1
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- sponsorDuties code: 6
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties code: 6
- Name
- Signant Health LLC
- Responsibilities
- sponsorDuties code: 3
Third parties
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"IP Supplies","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":"Iqvia Rds Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"CMT Cellex Manufacturing Transports and Logistics GmbH","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
- Active Substance
- CILTACABTAGENE AUTOLEUCEL
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Investigational Product Name
- DARZALEX 1800 mg solution for injection
- Active Substance
- DARATUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
- Investigational Product Name
- Pomalidomide (Imnovid / Pomalidomide products listed)
- Active Substance
- POMALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (Imnovid entries) / Authorisation status varies by product entry
- Orphan Designation
- True (Imnovid entries where orphanDrugEdit=true)
- Investigational Product Name
- BORTEZOMIB
- Active Substance
- BORTEZOMIB
- Modality
- Small molecule
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- Authorised (product listed as comparator)
- Investigational Product Name
- Dexamethasone (various tablet products listed)
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (various commercial products listed)
- Investigational Product Name
- FLUDARABINE
- Active Substance
- FLUDARABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (listed as auxiliary product)
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS USE
- Authorisation Status
- Authorised (listed as auxiliary product)
- Combination Treatment
- Yes
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- LISOCABTAGENE MARALEUCEL for Follicular lymphoma | Marginal zone lymphoma | Relapsed or refractory indolent B-cell non-Hodgkin lymphoma
- MIRDAMETINIB for Neurofibromatosis type 1 associated plexiform neurofibroma
- (12M)-(1S,2S)-N-((63S,4S,Z)-11-ETHYL-12-(2-((S)-1-METHOXYETHYL)-5-(4-METHYLPIPERAZIN-1-YL)PYRIDIN-3-YL)-10,10-DIMETHYL-5,7-DIOXO-61,62,63,64,65,66-HEXAHYDRO-11H-8-OXA-2(4,2)-THIAZOLA-1(5,3)-INDOLA-6(1,3)-PYRIDAZINACYCLOUNDECAPHANE-4-YL)-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE for Resected pancreatic ductal adenocarcinoma (PDAC)
- REVUMENIB for Acute Myeloid Leukemia
- N-[[(2S)-4-[(4-METHYL-1H-IMIDAZOL-5-YL)METHYL]-3-OXO-2-(PHENYLMETHYL)-1-PIPERAZINYL]CARBONYL]-L-LEUCINE TRIHYDRATE for Cutaneous T-cell lymphoma