Clinical trial • Phase III • Oncology
19CP02 for Multiple myeloma | B-cell non-Hodgkin lymphoma | Chronic lymphocytic leukemia | Small lymphocytic lymphoma
Phase III trial of 19CP02 for Multiple myeloma | B-cell non-Hodgkin lymphoma | Chronic lymphocytic leukemia | Small lymphocytic lymphoma. open-label.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma | B-cell non-Hodgkin lymphoma | Chronic lymphocytic leukemia | Small lymphocytic lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy|Gene therapy
Key dates
- Initial CTIS Submission Date
- 28-02-2024
- First CTIS Authorization Date
- 17-06-2024
Trial design
open-label Phase III trial across 11 sites in Belgium, Spain, Netherlands and others.
- Open Label
- Yes
- Target Sample Size
- 64
- Trial Duration For Participant
- 5475
Eligibility
Recruits 64 Vulnerable population selected. Informed consent must be signed and dated by the subject prior to any study-related procedures. A legal representative informed consent form is provided for at least Finland (document: L1_SIS-ICF_Legal Representative_FI_fi_FP)..
- Vulnerable Population
- Vulnerable population selected. Informed consent must be signed and dated by the subject prior to any study-related procedures. A legal representative informed consent form is provided for at least Finland (document: L1_SIS-ICF_Legal Representative_FI_fi_FP).
Inclusion criteria
- {"criterion_text":"- Subject must sign and date the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any study-related procedures.\n- Subjects has been treated with a GLPG CAR T-cell therapy in a clinical trial or Managed Access Program."}
Exclusion criteria
- {"criterion_text":"- There are no exclusion criteria for this study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The type and incidence of targeted adverse events (AEs)","definition_or_measurement_approach":"As stated: collection and reporting of the type and incidence of targeted AEs (no further definition provided in the record)."}
- {"endpoint_text":"- The type and incidence of serious AEs (SAEs) considered related to the GLPG CAR T-cell therapy","definition_or_measurement_approach":"As stated: collection and reporting of the type and incidence of SAEs considered related to the GLPG CAR T-cell therapy (no further definition provided in the record)."}
- {"endpoint_text":"- The pattern of vector integration sites, if vector sequences are detected in new malignancies, or in at least 1% of peripheral blood mononuclear cells (PBMCs)","definition_or_measurement_approach":"Assessment of vector integration site patterns when vector sequences are detected in new malignancies or when vector sequences are present in ≥1% of PBMCs."}
- {"endpoint_text":"- The incidence of detectable replication-competent lentivirus (RCL) in peripheral blood","definition_or_measurement_approach":"Detection and reporting of any replication-competent lentivirus (RCL) identified in peripheral blood."}
- {"endpoint_text":"- Cause-specific mortality","definition_or_measurement_approach":"Reporting of mortality by cause (no further measurement details provided in the record)."}
Secondary endpoints
- {"endpoint_text":"- Disease progression status","definition_or_measurement_approach":"As stated: assessment of disease progression status (no further definition provided in the record)."}
- {"endpoint_text":"- Time to subsequent anticancer therapy","definition_or_measurement_approach":"As stated: measurement of time until next anticancer therapy (no further definition provided in the record)."}
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"As stated: overall survival measurement (no further definition provided in the record)."}
- {"endpoint_text":"- The incidence of detectable CAR transgene in peripheral blood over time","definition_or_measurement_approach":"Assessment of detectability of CAR transgene in peripheral blood longitudinally over time."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 64
- Recruitment Window Months
- 180
- Consent Approach
- Subjects must sign and date an informed consent form (ICF) approved by the IEC/IRB prior to any study-related procedures. Multiple ICF documents are available in different languages (e.g. L1_SIS-ICF_Main in nl and fr, L1_SIS-ICF_Pregnancy, L1_SIS-ICF_Donation of samples). A legal representative ICF exists for Finland (L1_SIS-ICF_Legal Representative_FI_fi_FP), indicating provision for consent by legal representative where applicable.
Methods
- Site-level recruitment process documents (K1_Recruit Process / K1_Recruit-ICF process) — site-based recruitment materials are provided (multiple language versions).
- Email communications (documents titled K2_Recruit Mat_SC_Email Comm in multiple language versions) — email channel for study information/communication.
- Reloadable brochures and mailers (documents titled K2_Recruit Mat_SC_Reloadable Brochure / Reloadable Mailer) — printed/digital brochure/mailer materials for recruitment.
- Study brochures and study-specific reloadable materials (K2_Recruit Mat_SC_Study Brochure) — informational brochures in multiple languages.
- ScoutPass reloadable mailer/brochure and other Finland-specific recruitment materials (L2_SC_PFD_Reloadable ScoutPass Mailer/Brochure) associated with Finland MSC.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 186
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 24
- Number Of Sites
- 5
- Number Of Participants
- 61
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Hematology
- Contact Person Name
- Guillaume Dachy
- Contact Person Email
- Guillaume.dachy@saintluc.uclouvain.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Hematology
- Contact Person Name
- Rutger Callens
- Contact Person Email
- rutger.callens@azdelta.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Contact Person Name
- Koen Debackere
- Contact Person Email
- koen.debackere@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Hematology
- Contact Person Name
- Sébastien Anguille
- Contact Person Email
- Sebastien.anguille@uza.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Hematology
- Contact Person Name
- Evelyne Willems
- Contact Person Email
- e.willems@chuliege.be
Spain
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 21-06-2024
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematology
- Contact Person Name
- Natalia Tovar
- Contact Person Email
- ntovar@clinic.cat
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 20-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 4
- Number Of Participants
- 107
Sites
- Site Name
- Universiteit Maastricht
- Department Name
- Hematology
- Contact Person Name
- Marjolein Van der Poel
- Contact Person Email
- marjolein.vander.poel@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Contact Person Name
- Pim Mutsaers
- Contact Person Email
- p.mutsaers@erasmusmc.nl
- Site Name
- Academisch Medisch Centrum
- Department Name
- Hematology
- Contact Person Name
- Marie José Kersten
- Contact Person Email
- m.j.kersten@amsterdamumc.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Hematology
- Contact Person Name
- Joost Vermaat
- Contact Person Email
- j.s.p.vermaat@lumc.nl
Finland
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 9
Sites
- Site Name
- HUS-yhtymae
- Department Name
- Department of oncology
- Contact Person Name
- Sirpa Leppä
- Contact Person Email
- sirpa.leppa@hus.fi
Sponsor
Primary sponsor
- Full Name
- Galapagos
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Sponsor duties codes: 1,11,12,15,4,5,8 (includes Study Startup and Site Management); contact: CTISApplications-Pharma@iconplc.com
- Name
- IQVIA Limited
- Responsibilities
- Sponsor duties code: 6; contact: eu_clinical_trials_information@iqvia.com
- Name
- SGS Belgium
- Responsibilities
- Sponsor duties code: 8 (SAE processing); contact: be.life.SAEprocessing@sgs.com
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1, 11, 12, 15 (Study Startup and Site Management), 4, 5, 8; contact: CTISApplications-Pharma@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: 6; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"Sponsor duties codes: 8; contact: be.life.SAEprocessing@sgs.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- 19CP02
- Active Substance
- 19CP02
- Modality
- Cell therapy|Gene therapy
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Maximum Dose
- 250 Munit million units (maxDailyDoseAmount/maxTotalDoseAmount reported as 250)
- Investigational Product Name
- BCMACP03
- Active Substance
- BCMACP03
- Modality
- Cell therapy|Gene therapy
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- Intravenous
- Maximum Dose
- 300 Miu iu(1,000,000s) (maxDailyDoseAmount/maxTotalDoseAmount reported as 300)
- Investigational Product Name
- BCN-CP01
- Active Substance
- BCN-CP01
- Modality
- Cell therapy|Gene therapy
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Maximum Dose
- 300 Miu iu(1,000,000s) (maxDailyDoseAmount/maxTotalDoseAmount reported as 300)
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