Clinical trial • Phase III • Oncology
ANITOCABTAGENE AUTOLEUCEL for Relapsed/refractory multiple myeloma
Phase III trial of ANITOCABTAGENE AUTOLEUCEL for Relapsed/refractory multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed/refractory multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy|Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 26-07-2024
- First CTIS Authorization Date
- 09-12-2024
Trial design
Randomised, open-label, standard of care therapy (soct) chosen by investigator: one of pvd, dpd, kdd, or kd. comparator agents explicitly listed include darzalex (daratumumab), imnovid (pomalidomide), kyprolis (carfilzomib), bortezomib (bortezomib fresenius kabi), and neofordex (dexamethasone). doses and schedules are not specified in the ctis metadata.-controlled Phase III trial in Germany, Italy, Austria and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Standard of care therapy (SOCT) chosen by investigator: one of PVd, DPd, KDd, or Kd. Comparator agents explicitly listed include DARZALEX (daratumumab), Imnovid (pomalidomide), Kyprolis (carfilzomib), Bortezomib (Bortezomib Fresenius Kabi), and Neofordex (dexamethasone). Doses and schedules are not specified in the CTIS metadata.
- Target Sample Size
- 450
Eligibility
Recruits 450 Vulnerable population flag selected. Participants must be adults (18 years or older) and provide written informed consent. Separate informed consent forms are provided for pregnant participants, pregnant partners, caregivers, and for scout/telephone pre-ICF procedures (language- and country-specific ICFs are available). No paediatric assent procedures are included (study limited to adults)..
- Pregnancy Exclusion
- Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
- Vulnerable Population
- Vulnerable population flag selected. Participants must be adults (18 years or older) and provide written informed consent. Separate informed consent forms are provided for pregnant participants, pregnant partners, caregivers, and for scout/telephone pre-ICF procedures (language- and country-specific ICFs are available). No paediatric assent procedures are included (study limited to adults).
Inclusion criteria
- {"criterion_text":"- Documented historical diagnosis of MM"}
- {"criterion_text":"- Received 1 to 3 prior lines of antimyeloma therapy, including an IMiD and an anti-CD38 mAb. A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy."}
- {"criterion_text":"- Documented evidence of progressive disease by IMWG criteria based on the investigator’s determination on or within 12 months of the last dose of the last regimen"}
- {"criterion_text":"- Measurable disease at screening per IMWG, defined as any of the following: a) Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or b) Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio"}
- {"criterion_text":"- Only participants who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this Study"}
- {"criterion_text":"- Male or female aged 18 years or older and who have provided written informed consent"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
- {"criterion_text":"- Females of childbearing potential must have a medically supervised negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)"}
Exclusion criteria
- {"criterion_text":"- Prior BCMA-targeted therapy"}
- {"criterion_text":"- Prior T-cell engager therapy"}
- {"criterion_text":"- Prior CAR therapy or other genetically modified T-cell therapy"}
- {"criterion_text":"- Active or prior history of central nervous system (CNS) or meningeal involvement of MM"}
- {"criterion_text":"- Cardiac atrial or cardiac ventricular MM involvement"}
- {"criterion_text":"- History of or active plasma cell leukemia (defined as 5% circulating plasma cells per IMWG 2021 consensus definition , Waldenstrom’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis"}
- {"criterion_text":"- Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted."}
- {"criterion_text":"- Prior auto-SCT within 12 weeks before randomization"}
- {"criterion_text":"- Prior allogeneic stem cell transplant (allo-SCT)"}
- {"criterion_text":"- High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization"}
- {"criterion_text":"- Live vaccine ≤ 4 weeks before randomization"}
- {"criterion_text":"- Contraindication to fludarabine or cyclophosphamide"}
- {"criterion_text":"- History of allergy or hypersensitivity to any study agent or study drug components. Participants with a history of severe hypersensitivity reaction including anaphylaxis due to dimethyl sulfoxide (DMSO) or gentamicin are excluded."}
- {"criterion_text":"- Life expectancy < 12 weeks"}
Endpoints
Primary endpoints
- {"endpoint_text":"- PFS, defined as the time to disease progression per IMWG criteria as determined by IRC, or death due to any cause, whichever occurs first","definition_or_measurement_approach":"Time to disease progression per IMWG criteria as determined by an Independent Review Committee (IRC), or death from any cause, whichever occurs first."}
- {"endpoint_text":"- Minimal residual disease (MRD)-negative complete response (CR) rate at 9 months, defined as the proportion of participants achieving CR/stringent CR (sCR) and MRD-negative status at 9 months. MRD negativity at 9 months is defined as negative MRD value at 9 months (± 3 months) in bone marrow assessment (< 1 in 10^5 nucleated cells per IMWG criteria using NGS) {Kumar 2016}. CR/sCR per IMWG criteria is determined by IRC","definition_or_measurement_approach":"Proportion of participants achieving CR/sCR and MRD-negative status at 9 months (±3 months) by bone marrow assessment using NGS (<1 in 10^5 nucleated cells) per IMWG criteria; CR/sCR determined by Independent Review Committee (IRC)."}
Secondary endpoints
- {"endpoint_text":"- Complete response (CR) rate (CR/stringent CR [sCR]) per IMWG criteria by IRC","definition_or_measurement_approach":"CR/sCR determined by Independent Review Committee (IRC) according to IMWG criteria."}
- {"endpoint_text":"- Overall minimal residual disease (MRD) negativity (minimum 10^−5)","definition_or_measurement_approach":"MRD negativity assessed at sensitivity of at least 10^-5 (methodology: NGS as per protocol)."}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"Time from randomization to death from any cause."}
- {"endpoint_text":"- Overall response rate","definition_or_measurement_approach":"Proportion of participants achieving a predefined response per IMWG criteria."}
- {"endpoint_text":"- MRD-negative CR/sCR and MRD-negative very good partial response (VGPR)+","definition_or_measurement_approach":"MRD-negative status combined with CR/sCR and MRD-negative VGPR+ as assessed by bone marrow NGS per IMWG criteria."}
- {"endpoint_text":"- Sustained MRD negativity","definition_or_measurement_approach":"Duration of maintained MRD negativity as defined in protocol assessments."}
- {"endpoint_text":"- Duration of response","definition_or_measurement_approach":"Time from first documented response to disease progression or death."}
- {"endpoint_text":"- Time to progression","definition_or_measurement_approach":"Time from randomization to documented disease progression per IMWG criteria."}
- {"endpoint_text":"- Time to next treatment","definition_or_measurement_approach":"Time from randomization to initiation of next line of antimyeloma therapy."}
- {"endpoint_text":"- Incidence, seriousness, and severity of all adverse events (AEs)","definition_or_measurement_approach":"Standard AE reporting (incidence, seriousness, and severity) as captured in case report forms and safety reporting per protocol."}
- {"endpoint_text":"- Levels of anti-anitocabtagene autoleucel chimeric antigen receptor (CAR) antibodies (anitocabtagene autoleucel arm)","definition_or_measurement_approach":"Measurement of anti-CAR antibody levels in participants receiving anitocabtagene autoleucel."}
- {"endpoint_text":"- Presence of replication-competent lentivirus (RCL) (anitocabtagene autoleucel arm)","definition_or_measurement_approach":"Testing for replication-competent lentivirus in biospecimens from participants in the CAR-T arm."}
- {"endpoint_text":"- Change from baseline quality of life scores across postbaseline assessment visits as measured by: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Multiple Myeloma Module (EORTC QLQ-MY20). European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)","definition_or_measurement_approach":"Patient-reported outcome (PRO) instruments: EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D-5L; change from baseline across scheduled post-baseline visits."}
- {"endpoint_text":"- Frequency of hospitalizations, inpatient days, intensive care unit days, and reasons for hospitalization","definition_or_measurement_approach":"Health resource utilization measures collected during study follow-up (number and reasons for hospitalizations, inpatient and ICU days)."}
Recruitment
- Digital Remote Recruitment
- True, telephone-based pre-screening and consent support are described (documents include SC-telephone-Pre-ICF, Scout telephone consent, Telephone-Data-ICF and country-specific scout/telephone consent forms).
- Planned Sample Size
- 450
- Recruitment Window Months
- 82
- Consent Approach
- Written informed consent required from participants (study restricted to adults ≥18 years). Country- and language-specific main ICFs are provided (documents available in DE, FR, IT, NL, PL, CZ, ES, EN and others). Separate ICFs are available for pregnant participants, pregnant partners, caregivers, optional future research, telephone/scout pre-ICF and telephone data consent procedures.
Methods
- Country-specific recruitment arrangements documents (K1) and patient recruitment flyers (K2) are used (documents available for DE, IT, AT, CZ, BE, ES, NL, PL, FR).
- GP letters (country-specific; e.g. GP-Letter_IT) to primary care physicians to support referral (document present for Italy).
- Site-based recruitment (site desk support and site materials) — trial sites listed per country; desk support provided by CRO/vendors (Medidata, PPD).
- Pre-screening and scout telephone contact procedures (Scout and SC-telephone-Pre-ICF documents) to identify potential participants.
Geography
- Total Number Of Sites
- 51
- Total Number Of Participants
- 192
Germany
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 495
- Number Of Sites
- 8
- Number Of Participants
- 24
Sites
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik
- Contact Person Name
- Katja Weisel
- Contact Person Email
- k.weisel@uke.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik für Innere Medizin I, ITZ, Schwerpunkt Hämatologie, Onkologie und Stammzelltransplantation
- Contact Person Name
- Ralph Wäsch
- Contact Person Email
- ralph.waesch@uniklinik-freiburg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Klinik und Poliklinik II
- Contact Person Name
- Johannes Waldschmidt
- Contact Person Email
- Waldschmid_J@ukw.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation Westdeutsches Tumorzentrum Essen
- Contact Person Name
- Bastian von Tresckow
- Contact Person Email
- bastian.vontresckow@uk-essen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Campus Benjamin Franklin (CBF) Med. Klinik m. Schwerpunkt Hämatologie, Onkologie u. Tumorimmunologie
- Contact Person Name
- Stephan Bohl
- Contact Person Email
- stephan.bohl@charite.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie, Studieneinh
- Contact Person Name
- Vladan Vucinic
- Contact Person Email
- vladan.vucinic@medizin.uni-leipzig.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III, Hämatologie/Onkologie
- Contact Person Name
- Judith Hecker
- Contact Person Email
- judith.hecker@mri.tum.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik für Innere Medizin I
- Contact Person Name
- Tim Richardson
- Contact Person Email
- tim.richardson@uk-koeln.de
Italy
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 489
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UOC Ematologia
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- UOE-TMO
- Contact Person Name
- Fabio Ciceri
- Contact Person Email
- ciceri.clinicaltrials@hsr.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Servizio e DH di Ematologia e Trapianto di cellule staminali
- 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
- SC Ematologia U
- Contact Person Name
- Benedetto Bruno
- Contact Person Email
- Benedetto.bruno@unito.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- S.C. Ematologia – Trapianto di Midollo Osseo Allogenico
- Contact Person Name
- Paolo Corradini
- Contact Person Email
- paolo.corradini@unimi.it
Austria
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 466
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Noe LGA Gesundheit Region Mitte GmbH
- Department Name
- Klinische Abteilung für Innere Medizin 1, Hämatoonkologie
- Contact Person Name
- Petra Pichler
- Contact Person Email
- petra.pichler@stpoelten.lknoe.at
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU
- Contact Person Name
- Michael Leisch
- Contact Person Email
- m.leisch@salk.at
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Innere Medizin I, Klinische Abteilung für Hämatologie und Hämostaseologie
- Contact Person Name
- Maria Krauth
- Contact Person Email
- maria.krauth@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie
- Contact Person Name
- Irene Strassl
- Contact Person Email
- irene.strassl@ordensklinikum.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 07-10-2024
- Latest Decision Or Authorization Date
- 17-02-2026
- Processing Time Days
- 498
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Contact Person Name
- Luděk Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Contact Person Name
- Roman Hájek
- Contact Person Email
- roman.hajek@fno.cz
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 488
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology Department
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- nikolas.kint@uzgent.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Hematology Department
- Contact Person Name
- Marie-Christiane Vekemans
- Contact Person Email
- hristiane.vekemans@saintluc.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Hematology Department
- Contact Person Name
- Koen Debackere
- Contact Person Email
- koen.debackere@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Hematology Department
- Contact Person Name
- Sébastien Anguille
- Contact Person Email
- Sebastien.Anguille@uza.be
Spain
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 19-02-2026
- Processing Time Days
- 556
- Number Of Sites
- 11
- Number Of Participants
- 40
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Albert Oriol Rocafiguera
- Contact Person Email
- uicico_badalona@iconcologia.net
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Contact Person Name
- Maria Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Institut Catala D'oncologia (L'hospitalet)
- Department Name
- Hematology
- Contact Person Name
- Anna Sureda
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Contact Person Name
- Javier De la Rubia Comos
- Contact Person Email
- delarubia_jav@gva.es
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Hematology
- Contact Person Name
- Valentin Cabañas Perianes
- Contact Person Email
- valentin.cabanas@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Contact Person Name
- Javier Lopez Jimenez
- Contact Person Email
- jlopezj.hrc@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology
- Contact Person Name
- Juan Luis Reguera Ortega
- Contact Person Email
- juanlu_jlr@hotmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Contact Person Name
- Carlos Fernandez de Larrea
- Contact Person Email
- CFERNAN1@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Contact Person Name
- Joaquín Martínez López
- Contact Person Email
- jmarti01@ucm.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Contact Person Name
- Enrique Ocio San Miguel
- Contact Person Email
- enriquem.ocio@unican.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 553
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Contact Person Name
- Ruth Wester
- Contact Person Email
- r.wester@erasmusmc.nl
- Site Name
- Stichting Amsterdam UMC
- Department Name
- Hematology
- Contact Person Name
- Niels Van de Donk
- Contact Person Email
- hematology@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Hematology
- Contact Person Name
- Wilfried Roeloffzen
- Contact Person Email
- trialbureauhematologie@onco.umcg.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 12-11-2024
- Latest Decision Or Authorization Date
- 22-02-2026
- Processing Time Days
- 467
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Centralny Szpital Kliniczny, Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
- Contact Person Name
- Grzegorz Basak
- Contact Person Email
- Grzegorz.basak@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- tomasz.wrobel@usk.wroc.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
- Site Name
- Instytut Hematologii I Transfuzjologii
- Contact Person Name
- Ewa Lech-Marańda
- Contact Person Email
- emaranda@ihit.waw.pl
France
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 514
- Number Of Sites
- 10
- Number Of Participants
- 40
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d’Hématologie Clinque
- Contact Person Name
- Cyrille TOUZEAU
- Contact Person Email
- cyrille.touzeau@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service d’Hématologie
- Contact Person Name
- Lionel KARLIN
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d’Immuno-Hématologie
- Contact Person Name
- Bertrand ARNULF
- Contact Person Email
- bertrand.arnulf@sls.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service d‘Hématologie
- Contact Person Name
- Aurore PERROT
- Contact Person Email
- perrot.aurore@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service d’Hématologie
- Contact Person Name
- Pierre DAUFRESNE
- Contact Person Email
- pierre.daufresne@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service des Maladies du sang
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service d’Hématologie clinique
- Contact Person Name
- Laure VINCENT
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d’Hématologie et Thérapie Cellulaire
- Contact Person Name
- Xavier LELEU
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Institut Paoli Calmettes
- Department Name
- Service d’Hématologie
- Contact Person Name
- Jean-Marc SCHIANO DE COLELLA
- Contact Person Email
- schianojm@ipc.unicancer.fr
- Site Name
- Assistance Publique Hopitaux De Paris (184 Rue Du Faubourg Saint Antoine)
- Department Name
- Département de Thérapie Cellulaire et Hématologie Clinique
- Contact Person Name
- Mohamad MOHTY
- Contact Person Email
- mohamad.mohty@inserm.fr
Sponsor
Primary sponsor
- Full Name
- Kite Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Full service CRO for iMM-3: management of trial conduct, regulatory/start-up activities, central file preparation and maintenance, site management, and project management
Third parties
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Full service CRO for iMM-3: management of trial conduct, regulatory/start-up activities, central file preparation and maintenance, site management, and project management","organisation_type":"Industry"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"IXRS and randomization system","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata","duties_or_roles":"Desk support for sites","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Anitocabtagene autoleucel
- Active Substance
- ANITOCABTAGENE AUTOLEUCEL
- Modality
- Cell therapy
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Not authorised (prodAuthStatus: 1)
- Combination Treatment
- Yes
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