Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06729320
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-11
First Post:
2024-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-08', 'studyFirstSubmitDate': '2024-12-08', 'studyFirstSubmitQcDate': '2024-12-08', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recovery time of neutrophils', 'timeFrame': '1 year', 'description': 'On the first day after discontinuing G-CSF, the neutrophil count remained above 1.0 × 10\\^9/L for 7 consecutive days'}, {'measure': 'The recovery time of platelet', 'timeFrame': '1 year', 'description': 'Starting from the second day of the most recent platelet transfusion, the first day of platelet count\\>50 × 10\\^9/L lasting for 7 days'}, {'measure': 'Safety of infusion', 'timeFrame': '1 year', 'description': 'Acute allergies or infections related to umbilical cord blood mononuclear cell infusion, as well as shock and other infusion related reactions symptoms including but not limited to chills, fever, CRP, PCT, etc'}], 'secondaryOutcomes': [{'measure': 'Recovery of hemoglobin levels after infusion', 'timeFrame': '1 year', 'description': 'Hemoglobin content in blood routine examination'}, {'measure': 'Immune function reconstruction indicators at 1, 3, 6, and 12 months after transfusion', 'timeFrame': '1, 3, 6, and 12 months', 'description': 'Including but not limited to CD3, CD4, CD8, CD19, etc. in lymphoid subgroups'}, {'measure': 'Overall survival rate', 'timeFrame': '2 and 5 year', 'description': 'The proportion of participants who survived during the study period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Refractory Immune Effector Cell-related Hemocytopenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the safety and efficacy of umbilical cord blood mononuclear cell in the treatment of refractory immune effector cell-related hemocytopenia by observing the efficacy related factors and adverse reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old (including boundary values), gender is not limited\n2. ECOG score 0-2 points\n3. Expected survival ≥6 months\n4. Patients who have received immune effector cell therapy (marketed CAR-T cell therapy or dual antibody therapy) (no target), have grade 3-4 hemocytopenia after treatment, and do not recover to grade 2 within 3 weeks after conventional treatment. Defined as follows:\n\n1\\) The neutrophils again decreased to grade ≥3 within 1 week after G-CSF discontinuation, or 2) Unable to detach from red blood cell or platelet transfusion (infusion time less than one week requires re-infusion) (5) Understand the research protocol and sign the informed consent voluntarily\n\nExclusion Criteria:\n\n1. Patients who intend to undergo autologous hematopoietic stem cell transfusion or have undergone autologous hematopoietic stem cell transfusion\n2. Significant lack of compliance to complete the study plan (such as suffering from uncontrolled mental illness, etc.)\n3. Allergy or known allergy to any drug active ingredients, excipients, and blood products or preparations included in this study\n4. Pregnancy, breastfeeding, planning pregnancy, or unwillingness to use effective contraception as required by research\n5. There are other conditions that researchers believe are not suitable for inclusion'}, 'identificationModule': {'nctId': 'NCT06729320', 'briefTitle': 'A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'Beijing GoBroad Hospital'}, 'officialTitle': 'A Randomized Controlled, Open, Single-center Clinical Study Evaluating the Efficacy and Safety of Umbilical Cord Blood Mononuclear Cells in Patients with Refractory Immune Effector Cell-related Hemocytopenia', 'orgStudyIdInfo': {'id': 'UCB-MNCs-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional hematopoietic recovery therapy', 'description': 'Conventional hematopoietic recovery therapy including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.', 'interventionNames': ['Combination Product: Conventional hematopoietic recovery therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells', 'description': 'Umbilical cord blood mononuclear cells are obtained from umbilical cord blood by density gradient centrifugation', 'interventionNames': ['Biological: Umbilical cord blood mononuclear cells', 'Combination Product: Conventional hematopoietic recovery therapy']}], 'interventions': [{'name': 'Umbilical cord blood mononuclear cells', 'type': 'BIOLOGICAL', 'description': 'Intravenous infusion of UCB-MNCs (3×10\\^8/ time, once a week, four times in total)', 'armGroupLabels': ['Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells']}, {'name': 'Conventional hematopoietic recovery therapy', 'type': 'COMBINATION_PRODUCT', 'description': 'Including but not limited to G-CSF, TPO, TPO receptor agonists, transfusions of red blood cells, platelets, etc.', 'armGroupLabels': ['Conventional hematopoietic recovery therapy', 'Conventional hematopoietic recovery therapy+Umbilical cord blood mononuclear cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102200', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Kai Hu', 'role': 'CONTACT', 'email': 'huk@gobroadhealthcare.com', 'phone': '+86 150 1039 0336'}], 'facility': 'Beijing GoBroad Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Kai Hu', 'role': 'CONTACT', 'email': 'huk@gobroadhealthcare.com', 'phone': '+86 150 1039 0336'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing GoBroad Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kai Hu', 'investigatorAffiliation': 'Beijing GoBroad Hospital'}}}}