Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT03542669
Status:
UNKNOWN
Last Update Posted:
2022-03-02
First Post:
2018-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-11', 'studyFirstSubmitDate': '2018-05-20', 'studyFirstSubmitQcDate': '2018-05-20', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': '1 year', 'description': 'Determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer base on the AE, SAE and laboratory examination.'}], 'secondaryOutcomes': [{'measure': 'Changes of the cell immunophenotype', 'timeFrame': '1 year', 'description': 'Changes in the concentrations of the cell immunophenotype (CD3+, CD3+CD4+, CD3+CD8+, CD3-CD56+, CD3-CD19+) in peripheral blood after 6B11-OCIK injection from baseline.'}, {'measure': 'Changes of the antinuclear antibody (ANA)', 'timeFrame': '1 year', 'description': 'Changes in the concentrations of the antinuclear antibody (ANA) in peripheral blood after 6B11-OCIK injection from baseline.'}, {'measure': 'Changes of the C-reactive protein (CRP)', 'timeFrame': '1 year', 'description': 'Changes in the concentrations of the C-reactive protein (CRP) in peripheral blood after 6B11-OCIK injection from baseline.'}, {'measure': 'Changes of the interleukin-6 (IL-6)', 'timeFrame': '1 year', 'description': 'Changes in the concentrations of the interleukin-6 (IL-6) in peripheral blood after 6B11-OCIK injection from baseline.'}, {'measure': 'Changes of the immunoglobulin', 'timeFrame': '1 year', 'description': 'Changes in the concentrations of the immunoglobulin in peripheral blood after 6B11-OCIK injection from baseline.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '3 years', 'description': 'Percentage of patients who achieved CR and PR after treatment.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': '3 years', 'description': 'Percentage of evaluable patients who achieved CR, PR and SD after treatment.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '3 years', 'description': 'The period from the first infusion of 6B11-OCIK to first PD or death from any cause.'}, {'measure': 'Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.', 'timeFrame': '1 year', 'description': 'OC166-9 antigen expression and efficacy of 6B11-OCIK'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Ovarian Carcinoma', 'Platinum-resistant Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '34408750', 'type': 'DERIVED', 'citation': 'Cheng H, Ma R, Wang S, Wang Y, Li Y, Tang Z, Dou S, Wang Y, Zhu H, Ye X, Zhang T, Zhang Y, Li S, Zhao Y, Li Y, Cui H, Chang X. Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against Platinum-Resistant Recurrent or Refractory Ovarian Cancer. Front Immunol. 2021 Aug 2;12:707468. doi: 10.3389/fimmu.2021.707468. eCollection 2021.'}], 'seeAlsoLinks': [{'url': 'http://doi.org/10.3389/fimmu.2021.707468', 'label': 'Preliminary Safety and Potential Effect of 6B11-OCIK Adoptive Cell Therapy Against PlatinumResistant Recurrent or Refractory Ovarian Cancer,Frontiers in immunology,2021,12:707468'}]}, 'descriptionModule': {'briefSummary': 'This is an open, single-arm, phase I clinical trial to evaluate safety and efficacy and of 6b11-OCIK injection in the treatment of recurrent drug-resistant ovarian cancer', 'detailedDescription': 'This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells loaded with 6B11 anti-idiotype minibody (6b11-OCIK injection) for recurrent drug-resistant ovarian cancer. Main purpose of this research is to determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer. Moreover, secondary purpose is to evaluate the effect of 6B11-OCIK injection on the immune system of patients, the efficacy of autologous 6B11-OCIK injection in the treatment of patients with ovarian cancer obtain and the correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. Thirdly, exploratory purpose is to evaluate the effect of 6B11-OCIK injection on laboratory examination.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. 18-70 years old patients.\n2. Diagnosed as Ovarian Cancer, who had relapsed after initial treatment; Relapse after drug resistance: clinical remission after early chemotherapy, but progression or relapse within 6 months after chemotherapy,or achieve no response after early chemotherapy.\n3. Administered with Doxorubicin.\n\nExclusion criteria:\n\n1. Symptomatic and uncontrolled Brain metastasis or pia meningeal metastasis; Patients with spinal cord compression; Symptoms related to central nervous system lesions or symptoms indicating disease progression;\n2. Corticosteroid drugs (or analogues) or drugs effecting the immune system were administered before infusion in 4 weeks.\n3. Patients with interstitial lung disease or interstitial pneumonia, including clinically significant radiation pneumonia;\n4. Women with positive serum pregnancy test or lactation;'}, 'identificationModule': {'nctId': 'NCT03542669', 'briefTitle': 'Study of 6b11-OCIK Injection Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Phase I Study of Autologous Killer Cell Injection Induced by Dendritic Dells Loaded With 6B11 Anti-idiotype Minibody (6b11 - OCIK Injection) Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer', 'orgStudyIdInfo': {'id': '6B11-OCIK-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6B11-OCIK injection', 'interventionNames': ['Drug: 6B11-OCIK Injection', 'Drug: Doxorubicin']}], 'interventions': [{'name': '6B11-OCIK Injection', 'type': 'DRUG', 'description': 'Two infusions of 6B11-OCIK will be performed at each chemotherapy cycle (Day 3 an Day 7) during the first three cycles, while PBMC will be collected before each cycle (Day -12) during the first three cycles.', 'armGroupLabels': ['6B11-OCIK injection']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Subjects will be adminitered 4\\~6 cycles of chemotherapy (Doxorubicin, 30 mg/m\\^2 IV on Day 1 of every cycle)', 'armGroupLabels': ['6B11-OCIK injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'role': 'CONTACT', 'phone': '8610-88324472'}], 'facility': "Peking University People's hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaohong Chang', 'role': 'CONTACT', 'email': 'changxiaohong@pkuph.edu.cn', 'phone': '8610-88324472'}, {'name': 'hongyan Cheng', 'role': 'CONTACT', 'email': 'chyan7581@sina.com', 'phone': '8610-88324472'}], 'overallOfficials': [{'name': 'Xiaohong Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Weixiao Biotechnology Development Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gynaecologic Oncology Center', 'investigatorFullName': 'Changxiaohong', 'investigatorAffiliation': "Peking University People's Hospital"}}}}