Clinical trial • Phase IV • Oncology
ciltacabtagene autoleucel for Multiple myeloma
Phase IV trial of ciltacabtagene autoleucel for Multiple myeloma. open-label. 28 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase IV
- Drug Modality
- Cell therapy|Bispecific antibody|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 25-07-2024
- First CTIS Authorization Date
- 07-11-2024
Trial design
open-label Phase IV trial across 6 sites in Spain, Germany.
- Open Label
- Yes
- Target Sample Size
- 28
Eligibility
Recruits 28 Vulnerable population selected in Part I; no further details on consent or assent handling provided in the available documents..
- Vulnerable Population
- Vulnerable population selected in Part I; no further details on consent or assent handling provided in the available documents.
Recruitment
- Planned Sample Size
- 28
- Recruitment Window Months
- 72
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 12
Spain
- Earliest CTIS Part Ii Submission Date
- 15-08-2024
- Latest Decision Or Authorization Date
- 29-08-2025
- Processing Time Days
- 379
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez Lopez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez Lopez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematology
- Principal Investigator Name
- Enrique Maria Ocio San Miguel
- Principal Investigator Email
- enriquem.ocio@unican.es
- Contact Person Name
- Enrique Maria Ocio San Miguel
- Contact Person Email
- enriquem.ocio@unican.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
Germany
- Earliest CTIS Part Ii Submission Date
- 12-10-2024
- Latest Decision Or Authorization Date
- 01-09-2025
- Processing Time Days
- 324
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abteilung fur Innere Medizin II, Haematologie, Onkologie Rheumatololgie
- 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 Heidelberg AöR
- Department Name
- Innere Medizin V: Haematologie, Onkologie und Rheumatologie
- Principal Investigator Name
- Marc-Steffen Raab
- Principal Investigator Email
- Marc.Raab@med.uni-heidelberg.de
- Contact Person Name
- Marc-Steffen Raab
- Contact Person Email
- Marc.Raab@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Med. Klinik und Poliklinik II, Abteilung fur 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
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Ciltacabtagene autoleucel (Cilta-cel)
- Active Substance
- ciltacabtagene autoleucel
- Modality
- Cell therapy
- Investigational Product Name
- Talquetamab SC in combination with Daratumumab SC (Tal-D)
- Active Substance
- talquetamab; daratumumab
- Modality
- Bispecific antibody|Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- Teclistamab SC in combination with Daratumumab SC (Tec-D)
- Active Substance
- teclistamab; daratumumab
- Modality
- Bispecific antibody|Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Combination Treatment
- Yes
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