Clinical trial • Phase II • Haematology
SUROVATAMIG for Non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma
Phase II trial of SUROVATAMIG for Non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma. open-label, none/not specified-controlled.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-10-2024
- First CTIS Authorization Date
- 17-02-2025
Trial design
open-label, none/not specified-controlled Phase II trial across 21 sites in Italy, Denmark, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 188
Eligibility
Recruits 188 Vulnerable population is selected (isVulnerablePopulationSelected=true). Informed consent is handled using subject information sheets and informed consent forms (e.g. documents listed: L1_SIS and ICF Adult_redacted, L1_SIS and ICF Module 2_DLBCL_Redacted, L1_SIS and ICF Pregnant Partners, and other language versions). Participants must be 18 years or older and consent is provided by the adult participant. No assent process for minors is described in the available records..
- Vulnerable Population
- Vulnerable population is selected (isVulnerablePopulationSelected=true). Informed consent is handled using subject information sheets and informed consent forms (e.g. documents listed: L1_SIS and ICF Adult_redacted, L1_SIS and ICF Module 2_DLBCL_Redacted, L1_SIS and ICF Pregnant Partners, and other language versions). Participants must be 18 years or older and consent is provided by the adult participant. No assent process for minors is described in the available records.
Inclusion criteria
- {"criterion_text":"- 1. Participant must be 18 years old and above at the time of signing the ICF."}
- {"criterion_text":"- 2. ECOG performance status of 0 to 2"}
- {"criterion_text":"- 3. Relapsed or refractory disease after at least 2 prior lines of systemic therapy"}
- {"criterion_text":"- 4. Histologically confirmed diagnosis of B-NHL, based on local pathology report, as determined by WHO 2022 classification"}
- {"criterion_text":"- 5. FDG-avid and measurable disease"}
- {"criterion_text":"- 6. Adequate liver, hematological, renal and cardiac function."}
- {"criterion_text":"- The above is a summary, other inclusion criteria details may apply"}
Exclusion criteria
- {"criterion_text":"- 1. Diagnosis of chronic lymphocytic leukemia, Burkitt lymphoma, or Richter’s transformation"}
- {"criterion_text":"- 2. Active CNS involvement by B-NHL."}
- {"criterion_text":"- 3. Leukemic presentation of disease"}
- {"criterion_text":"- 4. Prior neurotoxicity/ICANS or CRS"}
- {"criterion_text":"- 5. History or presence of clinically relevant CNS pathology (based on investigator assessment)"}
- {"criterion_text":"- 6. Prior allogeneic HSCT or solid organ transplantation within 24 weeks of first planned dose of surovatamig"}
- {"criterion_text":"- The above is a summary, other exclusion criteria details may apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC","definition_or_measurement_approach":"Defined as proportion of participants achieving PR or CR based on Lugano 2014 Response Criteria as determined by an Independent Review Committee (IRC)."}
Secondary endpoints
- {"endpoint_text":"- 1. Safety and tolerability of surovatamig - incidence, nature, and severity of AEs/SAEs/AESI, changes in laboratory data, vital signs, and ECGs compared with baseline, incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs","definition_or_measurement_approach":"Incidence, nature and severity of adverse events/serious adverse events/adverse events of special interest; changes from baseline in labs, vital signs and ECGs; incidence and reasons for discontinuation, dose reduction and dose delay due to AEs."}
- {"endpoint_text":"- 2. Efficacy - DoR and CR, ORR and CR rates","definition_or_measurement_approach":"Duration of response (DoR), complete response (CR), objective response rate (ORR) and CR rates as per Lugano 2014 criteria."}
- {"endpoint_text":"- 3. Efficacy - DoCR, TTR, EFS, PFS, TTNT, OS","definition_or_measurement_approach":"DoCR (duration of complete response), time to response (TTR), event-free survival (EFS), progression-free survival (PFS), time to next treatment (TTNT), overall survival (OS) (definitions per protocol/Lugano criteria where applicable)."}
- {"endpoint_text":"- 4. PK - PK parameters such as such as Cmax, Tmax, Ctrough of surovatamig (at predefined intervals)","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, Tmax, Ctrough) measured at predefined intervals."}
- {"endpoint_text":"- 5. Immunogenicity -pre-existing and induced ADA for surovatamig","definition_or_measurement_approach":"Assessment of anti-drug antibodies (pre-existing and treatment-induced ADA) to surovatamig."}
- {"endpoint_text":"- 6. PROs - difference in severity levels in fatigue, pain, cognition and overall side-effect burden","definition_or_measurement_approach":"Patient-reported outcomes measuring severity levels for fatigue, pain, cognition and overall side-effect burden using specified questionnaires."}
- {"endpoint_text":"- 7. MRD-negative CR rate","definition_or_measurement_approach":"Rate of complete responses that are MRD-negative (minimal residual disease negative), as defined in protocol."}
Recruitment
- Planned Sample Size
- 188
- Recruitment Window Months
- 80
- Consent Approach
- Consent is obtained from adult participants (minimum age 18). Subject information sheets and informed consent forms (L1_SIS and ICF Adult, Module-specific ICFs, Pregnant Partner forms, optional genomics ICFs) are provided; patient-facing documents and questionnaires are available in multiple languages (documents available for FR, DK, DE, IT, ES, SE and English versions as indicated). The records indicate use of standard ICFs and SIS documents but do not describe assent or consent by legally authorized representatives in the public data.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 82
Italy
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 425
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- UOC Emalotogia
- Principal Investigator Name
- Ilaria Del Giudice
- Principal Investigator Email
- ilaria.delgiudice@uniroma1.it
- Contact Person Name
- Ilaria Del Giudice
- Contact Person Email
- ilaria.delgiudice@uniroma1.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
- Department Name
- SCDU Ematologia
- Principal Investigator Name
- Marco Ladetto
- Principal Investigator Email
- marco.ladetto@uniupo.it
- Contact Person Name
- Marco Ladetto
- Contact Person Email
- marco.ladetto@uniupo.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncoematologia
- Principal Investigator Name
- Enrico Derenzini
- Principal Investigator Email
- Enrico.Derenzini@ieo.it
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- Enrico.Derenzini@ieo.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Ematologia e Trapianto di Midollo Osseo
- Principal Investigator Name
- Andrés José Maria Ferreri
- Principal Investigator Email
- ferreri.andres@hsr.it
- Contact Person Name
- Andrés José Maria Ferreri
- Contact Person Email
- ferreri.andres@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UOC Ematologia
- Principal Investigator Name
- Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 424
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Lillebaelt Hospital
- Department Name
- Haematologisk Forskningsenhed HKFE
- Principal Investigator Name
- Michael Clausen
- Principal Investigator Email
- Michael.Roost.Clausen@rsyd.dk
- Contact Person Name
- Michael Clausen
- Contact Person Email
- Michael.Roost.Clausen@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Principal Investigator Name
- Caroline Riley
- Principal Investigator Email
- anna.caroline.riley@regionh.dk
- Contact Person Name
- Caroline Riley
- Contact Person Email
- anna.caroline.riley@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 427
- Number Of Sites
- 5
- Number Of Participants
- 22
Sites
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik fuer Innere Medizin II Abteilung Haematologie und Onkologie
- Principal Investigator Name
- Ulf Schnetzke
- Principal Investigator Email
- ulf.schnetzke@med.uni-jena.de
- Contact Person Name
- Ulf Schnetzke
- Contact Person Email
- ulf.schnetzke@med.uni-jena.de
- Site Name
- Klinikum Chemnitz gGmbH
- Department Name
- Klinik fuer Innere Medizin III
- Principal Investigator Name
- Mathias Haenel
- Principal Investigator Email
- m.haenel@skc.de
- Contact Person Name
- Mathias Haenel
- Contact Person Email
- m.haenel@skc.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Haematologie Onkologie und Palliativmedizin
- Principal Investigator Name
- Christian Scholz
- Principal Investigator Email
- christian.scholz@vivantes.de
- Contact Person Name
- Christian Scholz
- Contact Person Email
- christian.scholz@vivantes.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Abteilung fuer Haematologie und Stammzelltransplantation
- Principal Investigator Name
- Bastian von Tresckow
- Principal Investigator Email
- Bastian.vonTresckow@uk-essen.de
- Contact Person Name
- Bastian von Tresckow
- Contact Person Email
- Bastian.vonTresckow@uk-essen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Medizinische Poliklinik II
- Principal Investigator Name
- Max Topp
- Principal Investigator Email
- topp_m@ukw.de
- Contact Person Name
- Max Topp
- Contact Person Email
- topp_m@ukw.de
Spain
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 426
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematología
- Principal Investigator Name
- Pau Abrisqueta Costa
- Principal Investigator Email
- pabrisqueta@vhio.net
- Contact Person Name
- Pau Abrisqueta Costa
- Contact Person Email
- pabrisqueta@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematología
- Principal Investigator Name
- Sergio Ramos Cillán
- Principal Investigator Email
- sergio.ramosc@quironsalud.com
- Contact Person Name
- Sergio Ramos Cillán
- Contact Person Email
- sergio.ramosc@quironsalud.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematología
- Principal Investigator Name
- Carmen García Chamorro
- Principal Investigator Email
- mcarmen.chamorro@quironsalud.es
- Contact Person Name
- Carmen García Chamorro
- Contact Person Email
- mcarmen.chamorro@quironsalud.es
France
- Earliest CTIS Part Ii Submission Date
- 13-02-2025
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 448
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service hemato-oncologie
- Principal Investigator Name
- Catherine Thieblemont
- Principal Investigator Email
- catherine.thieblemont@aphp.fr
- Contact Person Name
- Catherine Thieblemont
- Contact Person Email
- catherine.thieblemont@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service hematologie clinique
- Principal Investigator Name
- Emmanuel Bachy
- Principal Investigator Email
- emmanuel.bachy@chu-lyon.fr
- Contact Person Name
- Emmanuel Bachy
- Contact Person Email
- emmanuel.bachy@chu-lyon.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Service d'hematologie
- Principal Investigator Name
- Fabrice Jardin
- Principal Investigator Email
- fabrice.jardin@chb.unicancer.fr
- Contact Person Name
- Fabrice Jardin
- Contact Person Email
- fabrice.jardin@chb.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service hematologie clinique
- Principal Investigator Name
- Guillaume Cartron
- Principal Investigator Email
- g-cartron@chu-montpellier.fr
- Contact Person Name
- Guillaume Cartron
- Contact Person Email
- g-cartron@chu-montpellier.fr
Sweden
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 469
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Sektion Hematologi/Koagulation
- Principal Investigator Name
- Per-Ola Andersson
- Principal Investigator Email
- per-ola.andersson@vgregion.se
- Contact Person Name
- Per-Ola Andersson
- Contact Person Email
- per-ola.andersson@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- Tema Cancer, medicinsk enhet Hematologi
- Principal Investigator Name
- Björn Wahlin
- Principal Investigator Email
- bjorn.wahlin@gmail.com
- Contact Person Name
- Björn Wahlin
- Contact Person Email
- bjorn.wahlin@gmail.com
Sponsor
Primary sponsor
- Full Name
- Astrazeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD0486
- Active Substance
- SUROVATAMIG
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Investigational Product Name
- AZD0486
- Active Substance
- HUMAN IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST CD3 AND CD19
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Authorised (prodAuthStatus=1)
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