Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-30 @ 2:48 AM
Study NCT ID:
NCT06932861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-22
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012208', 'term': 'Rhabdomyosarcoma'}], 'ancestors': [{'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event', 'timeFrame': 'From the first administration of the study drug until the occurrence of death, loss to follow-up, withdrawal of informed consent, initiation of a new anti-tumor therapy, or 21 days after the last dose, whichever comes first.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhabdomyosarcoma']}, 'descriptionModule': {'briefSummary': 'An Exploratory Study on the Use of mRNA Tumor Vaccines in the Treatment of Refractory Rhabdomyosarcoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing;\n2. Age ≥ 6 years;\n3. No known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life;\n4. Expected survival time greater than 6 months;\n5. ECOG performance status score of 0-1; -\n\nExclusion Criteria:\n\n* 1.History of or concurrent with other untreated malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 2.History of or current active autoimmune diseases. 3.Has uncontrolled cardiovascular diseases.'}, 'identificationModule': {'nctId': 'NCT06932861', 'briefTitle': 'Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Exploratory Study of Personalized mRNA Vaccine in Patients With Refractory Rhabdomyosarcoma', 'orgStudyIdInfo': {'id': 'PRRR Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaccine arm', 'interventionNames': ['Biological: mRNA Tumor Vaccine Therapy']}], 'interventions': [{'name': 'mRNA Tumor Vaccine Therapy', 'type': 'BIOLOGICAL', 'description': 'personalized mRNA vaccines', 'armGroupLabels': ['Vaccine arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xinxin Zhang', 'role': 'CONTACT', 'email': 'xinxinzhang66@hotmail.com', 'phone': '+86 15910520109'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinxin Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Otorhinolaryngology - Head and Neck Surgery，Clinical Professor', 'investigatorFullName': 'Xinxin Zhang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}