Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-31 @ 2:12 PM
Study NCT ID:
NCT06633328
Status:
RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000741', 'term': 'Anemia, Aplastic'}], 'ancestors': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000080983', 'term': 'Bone Marrow Failure Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity (DLT)', 'timeFrame': 'Up to 28 days after Treatment', 'description': 'Adverse events assessed according to NCI-CTCAE v5.0 criteria'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'Incidence of treatment-emergent adverse events \\[Safety and Tolerability\\]'}], 'secondaryOutcomes': [{'measure': 'Allogeneic hematopoietic stem cell transplant implantation rate', 'timeFrame': 'Up to 100 days after Treatment', 'description': 'The proportion of the number of patients who achieved hematopoietic reconstitution to the total number of allogeneic hematopoietic stem cell transplantation patients in the same period.'}, {'measure': 'Time to neutrophil and platelet engraftment', 'timeFrame': 'Up to 30 days after Treatment', 'description': 'The time for neutrophils and platelets to reach the implantation criteria after stem cell reinfusion'}, {'measure': 'Disease-feesurvival，DFS', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'The proportion of disease-free patients who survived to the total number of patients who transplanted allogeneic hematopoietic stem cells during the same period.'}, {'measure': 'Overall survival, OS', 'timeFrame': 'Up to 2 years after Treatment', 'description': 'After transplantation until death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allo-HSCT', 'CD7 CAR-T'], 'conditions': ['Aplastic Anemia']}, 'descriptionModule': {'briefSummary': 'This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with severe aplastic anemia', 'detailedDescription': 'This is a prospective, open-label, single-center clinical trial. This study will evaluate the safety and efficacy of CD7 CAR-T Bridging to allo-HSCT in the treatment of severe aplastic anemia.The primary endpoints are dose limiting toxicity (DLT) and the incidence of treatment emergent adverse event (TEAE).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese expert consensus on the diagnosis and treatment of aplastic anemia（2017）, Diagnosis of severe aplastic anemia ，1. The degree of bone marrow cell proliferation \\< 25%, or 25%-50% but residual hematopoietic cells \\< 30%；2. With pancytopenia (at least two of the following peripheral blood parameters) : (1) absolute neutrophil \\<0.5×10\\^9/L; (2) Platelet count\\< 20×10\\^9/L; (3) The absolute value of reticulocytes \\<20×109/L;\n* Suitable donors (relatives) with allogeneic HSCT indications and at least haploid allogeneic transplantation;\n* Patients who are not suitable or unwilling to undergo traditional allogeneic hematopoietic stem cell transplantation;\n* creatinine clearance \\> 60ml/min; without liver invasion, serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range. If there is liver invasion, serum erythrambirubin ≤ 3 times the upper limit of normal, and serum ALT and AST are both ≤ 5 times the upper limit of the normal range;\n* Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;\n* No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;\n* Estimated survival time ≥ 3 months;\n* ECOG performance status 0 to 1;\n* Females and males of childbearing potential must agree to use adequate contraception prior to study entry, during study participation, and for 6 months after infusion (the safety of this therapy for unborn children is not known and has unknown risks);\n* Those who voluntarily participated in this trial and provided informed consent;\n\nExclusion Criteria:\n\n* Allergy to pre-treatment measures；\n* Those with acute graft versus host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening; Those who have received systemic drug therapy for GvHD within 4 weeks before the reinfusion；\n* History of epilepsy or other central nervous system disorders；\n* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n* Less than 100 days after allogeneic hematopoietic stem cell transplantation；\n* Patients with HIV infection，Active infection of hepatitis B virus or hepatitis C virus，Uncured active infection；\n* The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;\n* Received anti-cancer chemotherapy or other drug treatment within 2 weeks prior to screening;\n* Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the study.'}, 'identificationModule': {'nctId': 'NCT06633328', 'briefTitle': 'CD7 CAR-T Bridging to alloHSCT for Severe Aplastic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Clinical Study on the Safety and Efficacy of Donor Derived CD7 CAR-T Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation for the for Patients With Severe Aplastic Anemia', 'orgStudyIdInfo': {'id': 'TXB2024009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Aplastic Anemia', 'interventionNames': ['Drug: CD7 CAR-T cells injection', 'Other: Allogeneic hematopoietic stem cell transplantation']}], 'interventions': [{'name': 'CD7 CAR-T cells injection', 'type': 'DRUG', 'description': 'CD7 CAR T cells treat patients with severe aplastic anemia', 'armGroupLabels': ['Treatment Group']}, {'name': 'Allogeneic hematopoietic stem cell transplantation', 'type': 'OTHER', 'description': 'In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with severe aplastic anemia', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310003', 'city': 'Hanzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '0571-87233772'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '0571-87233772'}], 'facility': 'The First Affiliated Hospital of Zhejiang University School of Medicine'}], 'centralContacts': [{'name': 'He Z Huang, MD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '13605714822'}, {'name': 'Yongxian Hu, MD', 'role': 'CONTACT', 'email': 'huyongxian2000@aliyun.com', 'phone': '86-15957162012'}], 'overallOfficials': [{'name': 'He Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yake Biotechnology Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'He Huang', 'investigatorAffiliation': 'Zhejiang University'}}}}