Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:21 PM
Study NCT ID:
NCT07356856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-13', 'studyFirstSubmitDate': '2026-01-13', 'studyFirstSubmitQcDate': '2026-01-13', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Events', 'timeFrame': '1 month', 'description': 'Treatment related mortality'}, {'measure': 'time of hematopoietic recovery', 'timeFrame': '1 month', 'description': 'Absolute neutrophil count \\>500/μL; Platelets ≥20,000/μL'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate, DCR', 'timeFrame': '1 year', 'description': '(markedly effective + effective + stable disease) / number of patients × 100%'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microtransplantation', 'solid tumors'], 'conditions': ['Advanced and Relapsed Solid Tumors']}, 'descriptionModule': {'briefSummary': 'In this study, microtransplantation (MST) will be administrated to patients diagnosed with advanced / relapsed solid tumors to assess the therapeutic efficacy and safety of conventional chemotherapy in combination with MST for the treatment of advanced/relapsed solid tumors.', 'detailedDescription': "In this study, the eligible patients will receive MST treatment following conventional chemotherapy, MST is the infusion of G-PBMCs after chemotherapy. G-PBMCs are peripheral blood mononuclear cells from HLA mismatched unrelated donors mobilized by granulocyte colony-stimulating factor (G-CSF).\n\nBased on the patient's medical history, current tumor assessment results, and the latest cancer treatment guidelines, an individualized chemotherapy plan for the patient is formulated through discussions among more than three oncologists. After each course of treatment, all relevant indicators, including efficacy and safety measures are evaluated.\n\nPatients will receive all treatment for four courses, with an interval of 21 to 28 days. After completing all the treatment courses, the patient will enter the evaluation stage. Patients who have entered the evaluation stage are permitted to receive any treatments, including symptomatic support treatment, after the completion of treatment or withdrawal from the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are 18 to 90 years old, regardless of gender or race;\n* Advanced / relapsed solid tumors (small cell lung cancer, ovarian cancer, cervical cancer, gastric and colorectal cancer, sarcoma, head and neck tumor, etc.) are confirmed by clinical or histopathological diagnosis;\n* More than two kinds of tumors are allowed;\n* Karnofsky score ≥ 40, ECoG physical status ≤ 3;\n* There are measurable lesions;\n\nExclusion Criteria:\n\n* The researchers considered patients who were not suitable to participate in this experiment；\n* Patients with mental disorders；\n* Patients who refuse to cooperate with the treatment；'}, 'identificationModule': {'nctId': 'NCT07356856', 'briefTitle': 'Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}, 'officialTitle': 'Efficacy and Safety of Microtransplantation for Advanced and Relapsed Solid Tumors', 'orgStudyIdInfo': {'id': 'MST-ST-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'microtransplantation; MST', 'description': 'conventional chemotherapy with microtransplantation', 'interventionNames': ['Biological: MST']}], 'interventions': [{'name': 'MST', 'type': 'BIOLOGICAL', 'description': 'conventional chemotherapy with microtransplantation(MST). Microtransplantation, which is the infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood mononuclear cells (GPBMC)', 'armGroupLabels': ['microtransplantation; MST']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haidian', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'yajing Huang, Professor', 'role': 'CONTACT', 'email': 'huangyajing@innovvy.com', 'phone': '86-15811031508'}], 'facility': 'Innovvy(Beijing) Biomedical Technology Co., Ltd', 'geoPoint': {'lat': 39.99064, 'lon': 116.28868}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'huiqin Wei, Professor', 'role': 'CONTACT', 'email': '99415185@qq.com', 'phone': '86-13978676174'}], 'facility': 'Minzu Hospital of Guangxi Zhuang Autonomous Region', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'contacts': [{'name': 'Xiang Lu, Professor', 'role': 'CONTACT', 'email': '2584779171@qq.com', 'phone': '86-18077107296'}, {'name': 'Xiang Lu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The First People's Hospital of Nanning", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}], 'centralContacts': [{'name': 'Xiang Lu, Professor', 'role': 'CONTACT', 'email': '2584779171@qq.com', 'phone': '86-18077107296'}], 'overallOfficials': [{'name': 'Xiang Lu, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The First People's Hospital of Nanning"}, {'name': 'huiqin Wei, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minzu Hospital of Guangxi Zhuang Autonomous Region'}, {'name': 'yajing Huang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Innovvy(Beijing) Biomedical Technology Co., Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'xiang lu', 'investigatorAffiliation': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}}}}