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Clinical trials for Anti-CD3 monoclonal antibody

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    23 result(s) found for: Anti-CD3 monoclonal antibody. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-001071-40 Sponsor Protocol Number: ISM10-06 Start Date*: 2011-08-11
    Sponsor Name:InSpira Medical AB
    Full Title: A Phase IIa Safety study of oral administration of anti-CD3 monoclonal antibody in non-responder genotype-I chronic Hepatitis C subjects, a single-blind, randomized, controlled multi-center study
    Medical condition: in non-responder genotype-I chronic Hepatitis C subjects
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10047457 Viral hepatitis C LLT
    14.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002248-98 Sponsor Protocol Number: TN-10 Start Date*: 2016-01-15
    Sponsor Name:TrialNet Coordinating Center
    Full Title: Anti-CD3 mAb (teplizumab) for prevention of diabetes in relatives at-risk for Type 1 diabetes mellitus
    Medical condition: Anti-CD3 monoclonal antibody is to be used for the prevention of type 1 diabetes mellitus in relatives at risk for developing the disease.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-001700-39 Sponsor Protocol Number: IP-REM-PK-01-EU Start Date*: 2005-09-14
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Determination of systemic exposure and characterization of pharmacokinetics of the tri-functional antibody catumaxomab (anti-EpCAM X anti-CD3) administered intraperitoneally in EpCAM positive cance...
    Medical condition: epithelial cell adhesion molecule (EpCAM) expressing tumors in patients with malignant ascites requiring therapeutic ascites puncture
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025538 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-001857-24 Sponsor Protocol Number: NI-0401-02 Start Date*: 2007-07-25
    Sponsor Name:NovImmune S.A.
    Full Title: A Phase IIa, open-label, dose-titration, multicentre study to assess the safety and preliminary efficacy of NI-0401 in patients with acute cellular renal allograftt rejection
    Medical condition: Acute cellular renal allograft rejection.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004294-21 Sponsor Protocol Number: FBT-IVREXBC 02 Start Date*: 2006-03-14
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Phase II study of the trifunctional anti-HER-2/neu x anti-CD3 antibody ertumaxomab for hormone therapy refractory patients with HER-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer
    Medical condition: Hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express HER-2/neu (1+ or 2+)
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) ES (Completed) IT (Prematurely Ended) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-003481-42 Sponsor Protocol Number: 291-417 Start Date*: 2006-04-21
    Sponsor Name:Protein Design Labs, Inc
    Full Title: A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
    Medical condition: Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) HU (Prematurely Ended) CZ (Completed) DE (Prematurely Ended) AT (Prematurely Ended) IE (Completed) ES (Ongoing) GR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002063-87 Sponsor Protocol Number: Protocol Number 291-415 Start Date*: 2006-03-16
    Sponsor Name:PDL BioPharma, Inc
    Full Title: A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis
    Medical condition: Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
    Disease: Version SOC Term Classification Code Term Level
    9.0 10045365 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) AT (Prematurely Ended) BE (Completed) CZ (Completed) DE (Prematurely Ended) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-003579-11 Sponsor Protocol Number: TRX4_DM_004_EU_06 Start Date*: 2007-03-23
    Sponsor Name:TolerRx, Inc.
    Full Title: Tolerability and Safety of Multiple Dose Regimens of TRX4 Anti-CD3 Monoclonal Antibody in Type 1 Diabetes Mellitus
    Medical condition: Type I Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-011606-41 Sponsor Protocol Number: CP-MGA031-03 Start Date*: 2009-09-15
    Sponsor Name:MacroGenics, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in C...
    Medical condition: Recent-onset type 1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Completed) NL (Prematurely Ended) ES (Completed) FI (Completed) GB (Completed) DE (Completed) BE (Completed) PL (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-003707-37 Sponsor Protocol Number: 291-416 Start Date*: 2007-05-25
    Sponsor Name:PDL BioPharma, Inc
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis
    Medical condition: Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
    Disease: Version SOC Term Classification Code Term Level
    9.0 10045365 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002798-92 Sponsor Protocol Number: PRV-031-003 Start Date*: 2021-05-17
    Sponsor Name:Provention Bio, Inc.
    Full Title: A Multicenter, Multinational Extension of Study PRV-031-001 to Evaluate the Long-Term Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Ado...
    Medical condition: Type 1 Diabetes (T1D)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10012594 Diabetes LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) CZ (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-003482-17 Sponsor Protocol Number: 291-418 Start Date*: 2006-03-03
    Sponsor Name:PDL BioPharma, Inc.
    Full Title: A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis
    Medical condition: Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
    Disease: Version SOC Term Classification Code Term Level
    8.0 10045265 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Prematurely Ended) ES (Ongoing) GR (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-008432-82 Sponsor Protocol Number: CP-MGA031-02 Start Date*: 2009-07-01
    Sponsor Name:MacroGenics, Inc.
    Full Title: A Multicenter, Multinational Extension of Study CP-MGA031-01 to Evaluate the Long-Term Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Chi...
    Medical condition: Recent-onset type 1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045228 Type I diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) ES (Prematurely Ended) SE (Prematurely Ended) LV (Prematurely Ended) EE (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-004387-72 Sponsor Protocol Number: 291-411 Start Date*: 2005-06-03
    Sponsor Name:PDL BioPharma, Inc.
    Full Title: A Phase IIa, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients with Crohn’s Disease.
    Medical condition: Crohn’s disease (CD) in patients with at least one perianal fistula.
    Disease: Version SOC Term Classification Code Term Level
    7.1 10011401 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004926-26 Sponsor Protocol Number: PRV-031-001 Start Date*: 2019-11-21
    Sponsor Name:Provention Bio, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in ...
    Medical condition: Type 1 Diabetes (T1D)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012594 Diabetes LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed) DE (Completed) FR (Completed) FI (Ongoing) BE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2018-001127-40 Sponsor Protocol Number: GO40554 Start Date*: 2019-05-10
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE I/II TRIAL OF MOSUNETUZUMAB (BTCT4465A) AS CONSOLIDATION THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA FOLLOWING FIRST-LINE IMMUNOCHEMOTHERAPY AND AS THERAPY IN PATIENTS WITH PREVI...
    Medical condition: B-cell non-Hodgkin lymphoma (NHL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2006-002457-69 Sponsor Protocol Number: CP-MGA031-01 Start Date*: 2008-12-04
    Sponsor Name:MacroGenics, Inc.
    Full Title: A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-C...
    Medical condition: Recent-onset type I diabetes mellitus (T1DM)
    Disease: Version SOC Term Classification Code Term Level
    9.0 10045228 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) SE (Completed) GB (Completed) EE (Completed) NL (Completed) LV (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-004388-31 Sponsor Protocol Number: 291-412 Start Date*: 2005-06-03
    Sponsor Name:PDL BioPharma, Inc
    Full Title: A Phase IIa, Open-label Study of Visilizumab in Patients with Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn’s Disease
    Medical condition: Moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn’s disease (CD).
    Disease: Version SOC Term Classification Code Term Level
    7.1 10011401 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022810-26 Sponsor Protocol Number: PERCAT01 Version 10, 31.01.2011 Start Date*: 2011-03-16
    Sponsor Name:University Witten/Herdecke
    Full Title: MULTICENTER, OPEN-LABEL PHASE II STUDY TO EVALUATE THE EFFICACY OF A 2-CYCLE IMMUNOTHERAPY WITH THE TRI FUNCTIONAL BISPECIFIC ANTIBODY CATUMAXOMAB (ANTI EPCAM X ANTI-CD3) IN ADDITION TO SYSTEMIC CH...
    Medical condition: PERITONEAL CARCINOMATOSIS FROM GASTRIC OR COLORECTAL ADENOCARCINOMA
    Disease: Version SOC Term Classification Code Term Level
    12.1 10068069 Peritoneal carcinomatosis LLT
    12.1 10052360 Colorectal adenocarcinoma LLT
    12.1 10017758 Gastric cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001039-29 Sponsor Protocol Number: GO40515 Start Date*: 2019-02-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, CONTROLLED STUDY INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH CHOP OR ...
    Medical condition: B-Cell Non-Hodgkin Lymphoma (B-cell NHL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10025320 Lymphomas non-Hodgkin's B-cell HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) AT (Completed) ES (Ongoing)
    Trial results: View results
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