Clinical trial • Phase I/II • Oncology
SUROVATAMIG (Human IgG4 kappa monoclonal antibody against CD3 and CD19) for Mantle cell lymphoma|Diffuse large B-cell lymphoma|Chronic lymphocytic leukaemia|Small lymphocytic lymphoma
Phase I/II trial of SUROVATAMIG (Human IgG4 kappa monoclonal antibody against CD3 and CD19) for Mantle cell lymphoma|Diffuse large B-cell lymphoma|Chronic…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Mantle cell lymphoma|Diffuse large B-cell lymphoma|Chronic lymphocytic leukaemia|Small lymphocytic lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 29-08-2024
- First CTIS Authorization Date
- 07-01-2025
Trial design
open-label, comparators listed in protocol: prednisone (prednisone/prednisolone), rituximab, doxorubicin (doxorubicin hydrochloride), vincristine, acalabrutinib (calquence), cyclophosphamide. dose and schedule not specified in the ctis metadata.-controlled, adaptive Phase I/II trial across 21 sites in Spain, Czechia, France and others.
- Open Label
- Yes
- Comparator
- Comparators listed in protocol: PREDNISONE (Prednisone/Prednisolone), RITUXIMAB, DOXORUBICIN (doxorubicin hydrochloride), VINCRISTINE, ACALABRUTINIB (Calquence), CYCLOPHOSPHAMIDE. Dose and schedule not specified in the CTIS metadata.
- Adaptive
- True, Dose-escalation to determine RP2D informed by DLT assessments and safety (RP2D determination is a stated main objective). Specific escalation rules or stopping rules not provided in the CTIS metadata.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 246
Eligibility
Recruits 246 Vulnerable population selected. Country-specific informed consent documents include specific forms for pregnant partners and other vulnerable-related procedures (documents titled 'Other Pregnant Partner ICF' and country ICF addenda). Consent is obtained via subject information and informed consent forms; participants are adults (Age ≥ 18). No assent procedures for minors are described..
- Vulnerable Population
- Vulnerable population selected. Country-specific informed consent documents include specific forms for pregnant partners and other vulnerable-related procedures (documents titled 'Other Pregnant Partner ICF' and country ICF addenda). Consent is obtained via subject information and informed consent forms; participants are adults (Age ≥ 18). No assent procedures for minors are described.
Inclusion criteria
- {"criterion_text":"- All sub- studies: Age ≥ 18 years\n- Sub-study 1, Cohort 1A and Cohort 1C: at least 2 prior lines of systemic therapy for CLL/SLL\n- Sub-study 1, Cohort 1B: at least 1 prior line of therapy and BTKi sensitive or naïve\n- Sub-study 2: MCL diagnosis per WHO\n- Sub-study 3: Absolute lymphocytes count of < 5 × 109 cells/L\n- Sub-study 3: Haemoglobin ≥ 9 g/dL\n- Sub-study 2: Clinical Stage II, III, or IV per Ann Arbor classification\n- Sub-study 2: At least 1 measurable site per Lugano\n- Sub-study 2: ALC < 10,000\n- Sub- study 2, Cohort 2A and Cohort 2C: Relapsed or Progressed after 2 or more prior systemic therapy for MCL including BTKi\n- Sub-study 3: Large B-cell lymphoma per WHO 2022 or R/R B-NHL after at least 1 prior line of therapy\n- Sub-study 3: LVEF >50%\n- Sub-study 3: IPI 2-5 for participants with untreated LBCL diagnoses\n- Sub-study 3: At least 1 measurable site as per Lugano\n- Sub-study 1: Contraception during treatment and until at least x days after the last dose of AZD0486 and until 2 days after the last dose of acalabrutinib, whichever is longer.\n- All sub- studies: ECOG performance status 0 to 2\n- Sub-study 3: Contraception until x days after the last dose of AZD0486, 4 months after the last dose of vincristine, and 6 months after the last dose of cyclophosphamide or doxorubicin, (or as required by local prescribing information) whichever is longer.\n- All sub-studies: Contraception during treatment and at least x days after final dose\n- All sub- studies: Confirmed CD19 expression if prior anti-CD19 therapy\n- Sub-study 1: CLL/SLL diagnosis and meets iwCLL criteria for treatment\n- Sub-study 1: SLL: at least 1 measurable site per Lugano\n- Sub-study 1: Absolute lymphocytes <10,000"}
Exclusion criteria
- {"criterion_text":"- All sub- studies: CNS lymphoma\n- All sub-studies: Radiation therapy within 28 days of Cycle 1 Day 1\n- All sub-studies: Prior CAR-T therapy or auto-HSCT within 12 weeks or prior TCE within 8 weeks of Cycle 1 Day 1\n- All sub- studies: Prior Grade ≥ 3 CRS or ICANS event\n- Sub-study 1: CLL transformation to more aggressive lymphoma\n- All sub- studies: Active, significant, or uncontrolled infection or autoimmune disease requiring systemic therapy which places participant at unacceptable risk if he/she were to participate in the study\n- Sub-study 1, Cohort 1B: bleeding diathesis, treatment with strong CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist\n- Sub-study 2 Exclusion Criteria Refer to Section 5.2 of the Master Protocol.\n- Sub-study 3: Mediastinal grey-zone lymphoma, Burkitt, Richter’s transformation, primary effusion LBCL\n- Sub-study 3: Cumulative dose of anthracycline ≥ 150 mg/m2\n- All sub- studies: Major Surgical procedure within 14 days before the first dose of study drug\n- All sub- studies: Clinically significant CV disease\n- All sub- studies: Unresolved non-haematological Grade ≥ 2 AEs (NCI CTCAE V5.0) from prior anticancer therapy (except alopecia or fatigue)\n- All sub-studies: Any anticancer systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to Cycle 1 Day 1"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence, nature and severity of AEs/SAEs based on NCI CTCAE v5.0/ASTCT criteria; changes in laboratory data, and vital signs compared with baseline","definition_or_measurement_approach":"Measured by NCI CTCAE v5.0 and ASTCT criteria; laboratory data and vital signs compared with baseline"}
- {"endpoint_text":"- Incidence of Dose Limiting Toxicity (DLTs)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence and severity of AESIs","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence and nature of study drug discontinuation, dose reduction and dose delay due to AEs","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 246
- Recruitment Window Months
- 36
- Consent Approach
- Informed consent is obtained using country-specific subject information and informed consent forms (multiple 'Country ICF' documents listed for Spain, Czechia, France, Germany, Denmark). Participants are adults (Age ≥ 18) and provide their own consent. Additional specific consent forms are provided for pregnant partners and optional procedures/genetic research. Consent materials are provided in local languages as evidenced by ICF document titles (e.g., Spanish, French, Czech, German, Danish, English). No assent process for minors is described.
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 200
Spain
- Earliest CTIS Part Ii Submission Date
- 04-12-2024
- Latest Decision Or Authorization Date
- 14-10-2025
- Processing Time Days
- 314
- Number Of Sites
- 6
- Number Of Participants
- 52
Sites
- Site Name
- University Hospital Son Espases
- Department Name
- 7002: Hematologia
- Principal Investigator Name
- Antonio Manuel Gutierrez Garcia
- Principal Investigator Email
- antoniom.gutierrez@ssib.es
- Contact Person Name
- Antonio Manuel Gutierrez Garcia
- Contact Person Email
- antoniom.gutierrez@ssib.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- 7006: Hematología
- Principal Investigator Name
- Javier López Jiménez
- Principal Investigator Email
- jljimenez@salud.madrid.org
- Contact Person Name
- Javier López Jiménez
- Contact Person Email
- jljimenez@salud.madrid.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- 7001: Hematología y Hemoterapia
- Principal Investigator Name
- Daniel Morillo Giles
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo Giles
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 7004: Hematología
- Principal Investigator Name
- Eva Giné Soca
- Principal Investigator Email
- EGINE@clinic.ub.es
- Contact Person Name
- Eva Giné Soca
- Contact Person Email
- EGINE@clinic.ub.es
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- 7003: Hematología
- Principal Investigator Name
- Adrián Mosquera Orgueira
- Principal Investigator Email
- Adrian.Mosquera.Orgeira@sergas.es
- Contact Person Name
- Adrián Mosquera Orgueira
- Contact Person Email
- Adrian.Mosquera.Orgeira@sergas.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- 7005: Hematología
- Principal Investigator Name
- Rafael Andreu Lapiedra
- Principal Investigator Email
- andreu_raflap@gva.es
- Contact Person Name
- Rafael Andreu Lapiedra
- Contact Person Email
- andreu_raflap@gva.es
Czechia
- Earliest CTIS Part Ii Submission Date
- 04-12-2024
- Latest Decision Or Authorization Date
- 14-10-2025
- Processing Time Days
- 314
- Number Of Sites
- 3
- Number Of Participants
- 32
Sites
- Site Name
- Institute Of Hematology And Blood Transfusion
- Department Name
- 1903:Oddělení buněčné terapie
- Principal Investigator Name
- Robert Pytlik
- Principal Investigator Email
- Robert.Pytlik@uhkt.cz
- Contact Person Name
- Robert Pytlik
- Contact Person Email
- Robert.Pytlik@uhkt.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- 1901:Klinika plicnich nemoci a TBC
- Principal Investigator Name
- Roman Hajek
- Principal Investigator Email
- roman.hajek@fno.cz
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 1902:I. Interni klinika - klinika hematologie VFN a 1. LF UK v Praze
- Principal Investigator Name
- Marek Trneny
- Principal Investigator Email
- trneny@cesnet.cz
- Contact Person Name
- Marek Trneny
- Contact Person Email
- trneny@cesnet.cz
France
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 09-10-2025
- Processing Time Days
- 363
- Number Of Sites
- 4
- Number Of Participants
- 36
Sites
- Site Name
- Hopital Saint Louis
- Department Name
- 2303: Service d’Hémato-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
- Institut Curie
- Department Name
- 2302: Oncology
- Principal Investigator Name
- Clementine Sarkozy
- Principal Investigator Email
- clementine.sarkozy@curie.fr
- Contact Person Name
- Clementine Sarkozy
- Contact Person Email
- clementine.sarkozy@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- 2301: Hématologie 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
- Site Name
- Institut Gustave Roussy
- Department Name
- 2304: Département d’Innovations Thérapeutiques et d’essais Précoces (DITEP)
- Principal Investigator Name
- Vincent Ribrag
- Principal Investigator Email
- vincent.ribrag@gustaveroussy.fr
- Contact Person Name
- Vincent Ribrag
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 04-12-2024
- Latest Decision Or Authorization Date
- 13-10-2025
- Processing Time Days
- 313
- Number Of Sites
- 4
- Number Of Participants
- 42
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- 2602:Hemat/Transfusion Med
- Principal Investigator Name
- Martin Dreyling
- Principal Investigator Email
- Martin.Dreyling@med.uni-muenchen.de
- Contact Person Name
- Martin Dreyling
- Contact Person Email
- Martin.Dreyling@med.uni-muenchen.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 2604: Schwerpunkt Endokrinologie
- Principal Investigator Name
- Georg Hess
- Principal Investigator Email
- georg.hess@unimedizin-mainz.de
- Contact Person Name
- Georg Hess
- Contact Person Email
- georg.hess@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- 2603:Medizinische Klinik II
- Principal Investigator Name
- Christiane Pott
- Principal Investigator Email
- c.pott@med2.uni-kiel.de
- Contact Person Name
- Christiane Pott
- Contact Person Email
- c.pott@med2.uni-kiel.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- 2601:Med. Klinik und 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
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-12-2024
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 344
- Number Of Sites
- 4
- Number Of Participants
- 38
Sites
- Site Name
- Rigshospitalet
- Department Name
- 2002:Department of Haematology and Phase 1 Unit.
- Principal Investigator Name
- Martin Hutchings
- Principal Investigator Email
- Martin.hutchings@regionh.dk
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- Martin.hutchings@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- 2003:Department of Haematology
- Principal Investigator Name
- Thor Høyer
- Principal Investigator Email
- thhc@rn.dk
- Contact Person Name
- Thor Høyer
- Contact Person Email
- thhc@rn.dk
- Site Name
- Region Midtjylland
- Department Name
- 2001:Department of Haematology
- Principal Investigator Name
- Hans Bentzen
- Principal Investigator Email
- hansbent@rm.dk
- Contact Person Name
- Hans Bentzen
- Contact Person Email
- hansbent@rm.dk
- Site Name
- Odense University Hospital
- Department Name
- 2004: Oncology
- Principal Investigator Name
- Jacob Haaber Christensen
- Principal Investigator Email
- jacob.h.christensen@rsyd.dk
- Contact Person Name
- Jacob Haaber Christensen
- Contact Person Email
- jacob.h.christensen@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Sponsor duties codes: 1,10,11,12,14,2,5,6,7,8,9; contact Clinicaltrial.Enquiries@parexel.com
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1,10,11,12,14,2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- AZD0486
- Active Substance
- SUROVATAMIG (Human IgG4 kappa monoclonal antibody against CD3 and CD19)
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous; Subcutaneous
- Authorisation Status
- Not authorised (prodAuthStatus:1)
- Combination Treatment
- Yes
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