Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Somatic Gene Therapy

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   43881   clinical trials with a EudraCT protocol, of which   7295   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    36 result(s) found for: Somatic Gene Therapy. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-002209-25 Sponsor Protocol Number: 67652000PCR3002 Start Date*: 2020-10-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Parti...
    Medical condition: Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) NL (Ongoing) DK (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) PT (Ongoing) BG (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002966-37 Sponsor Protocol Number: 1-2018BSMO Start Date*: 2019-01-23
    Sponsor Name:Belgian Society of Medical Oncology
    Full Title: Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.
    Medical condition: Advanced cancer patients that have a germline mutation or a somatic mutation in their tumor. Prostate and ovarian cancer patients and breast cancer patients who carry a BRCA1/2 mutation will be exc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001725-26 Sponsor Protocol Number: X-CGD-Version2 Start Date*: 2013-03-12
    Sponsor Name:Johann Wolfgang Goethe-University
    Full Title: A Phase I/II Gene Therapy trial for X-CGD with a SIN gamma retroviral vector
    Medical condition: Chronic granulomatous disease (CGD) is a congenital immunodeficiency, in which neutrophil granulocytes and monocytes are not capable of producing reactive oxygen species and therefore are unable to...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10008906 Chronic granulomatous disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000558-37 Sponsor Protocol Number: ARQ092-103 Start Date*: 2017-02-22
    Sponsor Name:ArQule, Inc.
    Full Title: A Phase 1/2 Study of ARQ 092 in Patients with Overgrowth Diseases and Vascular Anomalies with Genetic Alterations of the PI3K/AKT Pathway
    Medical condition: subjects (at least 6 years) suffering from diseases overgrowth and vascular anomalies with genetic alterations of the PI3K / AKT pathway.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) FR (Ongoing) ES (Temporarily Halted) GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002872-42 Sponsor Protocol Number: PUMA-NER-5201 Start Date*: 2014-03-25
    Sponsor Name:Puma Biotechnology, Inc
    Full Title: An Open-Label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR gene amplification
    Medical condition: Cancer tumor with somatic human epidermal growth factor receptor mutation (EGFR, ERBB2 (HER2), ERBB3 (HER3) or EGFR gene amplification
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed) FI (Completed) GB (GB - no longer in EU/EEA) DK (Completed) BE (Completed) FR (Ongoing) IE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000684-16 Sponsor Protocol Number: 03MI10 Start Date*: 2010-01-21
    Sponsor Name:Great Ormond Street Hospital NHS Trust / University College London - Institute of Child Health
    Full Title: Gene therapy for SCID-X1 using a self-inactivating (SIN) gammaretroviral vector.
    Medical condition: X-Linked severe combined Immunodeficiency (SCID-X1)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010099 Combined immunodeficiency LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-002806-28 Sponsor Protocol Number: SOLTI-1502 Start Date*: 2019-10-25
    Sponsor Name:SOLTI
    Full Title: TARGETING THE PAM50 HER2-ENRICHED PHENOTYPE WITH ENZALUTAMIDE IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE METASTATIC BREAST CANCER
    Medical condition: Male or pre/post-menopausal women age ≥ 18 years with advanced HR+/HER2-negative locally advanced/metastatic breast cancer resistant to endocrine therapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002808-28 Sponsor Protocol Number: OZM-061 Start Date*: 2017-12-29
    Sponsor Name:Princess Margaret Cancer Centre
    Full Title: Olala Trial: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
    Medical condition: epithelial ovarian cancer (including fallopian tube or peritoneal cancer)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061328 Ovarian epithelial cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004366-18 Sponsor Protocol Number: MAZEPPA_D19-02 Start Date*: 2020-03-03
    Sponsor Name:GERCOR
    Full Title: MAZEPPA: Phase II PRODIGE-GERCOR study to evaluate MAintenance therapy with olaparib or selumetinib plus durvalumab according to BRCAness and KRAS somatic status Personalized in metastatic Pancreat...
    Medical condition: Metastatic Pancreatic Adenocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033599 Pancreatic adenocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004868-30 Sponsor Protocol Number: PNET5MB Start Date*: 2013-10-31
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (...
    Medical condition: Children with medulloblastoma. Medulloblastoma is a highly cellular malignant embryonal neoplasm.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Restarted) BE (Ongoing) IT (Ongoing) FR (Ongoing) FI (Ongoing) SE (Ongoing) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Ongoing) NO (Completed) CZ (Ongoing) NL (Ongoing) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002051-42 Sponsor Protocol Number: R119861 Start Date*: 2019-10-25
    Sponsor Name:University of Manchester
    Full Title: A phase I-II, study of autologous CD34+ haematopoietic stem cells transduced ex vivo with CD11b lentiviral vector encoding for human SGSH in patients with mucopolysaccharidosis type IIIA (MPS IIIA,...
    Medical condition: MPS IIIA, mucopolysaccharidosis type IIIA
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10028093 Mucopolysaccharidosis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-005437-53 Sponsor Protocol Number: ITCC053 Start Date*: 2016-11-03
    Sponsor Name:Erasmus Medical Center
    Full Title: A phase 1B of crizotinib either in combination or as single agent in pediatric patients with ALK, ROS1 or MET positive malignancies Study ITCC 053
    Medical condition: Malignancies carrying a genetic alteration of ALK, MET or ROS1
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Ongoing) IE (Completed) ES (Ongoing) DK (Trial now transitioned) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000345-39 Sponsor Protocol Number: B9991032 Start Date*: 2019-02-19
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors
    Medical condition: locally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defect
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10065147 Malignant solid tumor LLT
    20.0 100000004864 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) BE (Completed) DK (Completed) ES (Ongoing) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-001205-73 Sponsor Protocol Number: IMP4297-202 Start Date*: 2021-08-24
    Sponsor Name:IMPACT Therapeutics, Inc.
    Full Title: A Randomized, Double-Blinded, Placebo-Controlled, Multicenter, Phase II Study to Evaluate Senaparib Maintenance in mCRPC Patients with Homologous Recombination Repair Gene Alterations after Docetax...
    Medical condition: metastatic castration-resistant prostate cancer (mCRPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: BE (Completed) FR (Ongoing) ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003200-14 Sponsor Protocol Number: JR-141-GS31 Start Date*: 2022-05-16
    Sponsor Name:JCR Pharmaceuticals Co., Ltd.
    Full Title: A Phase III study of JR-141 in Mucopolysaccharidosis type II (Hunter Syndrome) patients.
    Medical condition: Mucopolysaccharidosis type II
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056889 Mucopolysaccharidosis II PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) FR (Ongoing) PL (Ongoing) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003176-16 Sponsor Protocol Number: ADP-0055-003/GOG-3084 Start Date*: 2023-05-03
    Sponsor Name:Adaptimmune LLC
    Full Title: A PHASE 2, OPEN-LABEL, RANDOMIZED, NON-COMPARATIVE CLINICAL TRIAL OF ADP-A2M4CD8 MONOTHERAPY AND IN COMBINATION WITH NIVOLUMAB IN SUBJECTS WITH RECURRENT OVARIAN CANCERS (SURPASS-3 STUDY/ GOG-3084)
    Medical condition: Recurrent ovarian cancer positive for MAGE-A4 in human leukocyte antigen (HLA)-A2+ subjects
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-003832-57 Sponsor Protocol Number: UC-0140/1812 Start Date*: 2021-01-15
    Sponsor Name:UNICANCER
    Full Title: DOLAF- An international multicenter phase II trial of Durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients select...
    Medical condition: ER-positive and HER2-negative metastatic or locally advanced breast cancer with either a germline or somatic BRCA mutation, or a deleterious alteration of other genes involved in homologous recombi...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    23.0 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002198-40 Sponsor Protocol Number: DEN-STEM Start Date*: 2018-01-26
    Sponsor Name:Oslo University Hospital
    Full Title: Open label randomized phase II/III trial of dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy (DEN-STEM)
    Medical condition: Glioblastoma brain tumors
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018336 Glioblastoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000935-15 Sponsor Protocol Number: PRODIGE70-CIRCULATE Start Date*: 2019-09-10
    Sponsor Name:Centre Hospitalier Universitaire (CHU) de Dijon
    Full Title: CIRCULATE- CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
    Medical condition: stage II colon cancer, after tumour resection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004299-41 Sponsor Protocol Number: ERMES Start Date*: 2014-12-24
    Sponsor Name:Dipartimento di Scienze Mediche Oncologia Medica Policlinico Gemelli
    Full Title: ERbitux MEtastatic colorectal cancer Strategy Study: A phase III randomized two arm study with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by...
    Medical condition: Patients with unresectable RAS and BRAF wild-type metastatic colorectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Ongoing)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 19 19:11:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA