Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT06078306
Status:
UNKNOWN
Last Update Posted:
2024-04-22
First Post:
2023-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'C579720', 'term': 'venetoclax'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-10-05', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Remission Rate', 'timeFrame': 'The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion', 'description': 'MRD Negative Remission Rate after CD19CD22 cell therapy'}], 'secondaryOutcomes': [{'measure': 'Complete Remission Rate of VA regime', 'timeFrame': 'The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime', 'description': 'Complete Remission Rate after VA regime'}, {'measure': 'Complete Molecular Remission Rate', 'timeFrame': 'The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion', 'description': 'Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion', 'description': 'From the first infusion of CD19CD22 cells to death or the last visit'}, {'measure': 'Leukemia-free survival (LFS)', 'timeFrame': 'The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion', 'description': 'Up to 2 years after CD19CD22 CAR-T cells infusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Acute Lymphoblastic Leukemia', 'Ph-Negative ALL', 'High Risk Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL', 'detailedDescription': 'To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 and ≤65 years old\n2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification\n3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;\n4. Anticipated survival time more than 12 weeks;\n5. Those who voluntarily participated in this trial and provided informed consent.\n\nExclusion Criteria:\n\n1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;\n2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;\n3. Pregnant (or lactating) women;\n4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);\n5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus\n6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;\n7. Creatinine\\>2.5mg/dl, or ALT / AST \\> 3 times of normal amounts, or bilirubin\\>2.0 mg/dl;\n8. Other uncontrolled diseases that were not suitable for this trial;\n9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.'}, 'identificationModule': {'nctId': 'NCT06078306', 'briefTitle': 'CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Clinical Trial for the Safety and Efficacy of Induction Chemotherapy With Azacitidine+Venetoclax (VA) and Bridging CD19CD22 CAR-T Therapy in Adult Patients With Newly Diagnosed High-Risk and Ph-negative (Ph-) B-ALL', 'orgStudyIdInfo': {'id': 'High Risk B-ALL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T therapy', 'description': 'Therapeutic outcomes in adults with Ph- B-ALL have substantially improved in the last decade, with complete remission (CR) and long-term overall survival (OS) rates of around 90% and 40%-50%, respectively. The presence of measurable residual disease (MRD) is the strongest predictor of relapse in B-ALL. In this study, high risk Ph- B-ALL patients receive the induction chemotherapy with Azacitidine+Venetoclax. After induction chemotherapy with Azacitidine+Venetoclax (VA regime), each subject receives CD19CD22 CAR-T cells by intravenous infusion. The patients with MRD negative will undergo HSCT.', 'interventionNames': ['Drug: Azacitidine Injection', 'Drug: Venetoclax', 'Drug: CD19CD22 CAR-T']}], 'interventions': [{'name': 'Azacitidine Injection', 'type': 'DRUG', 'otherNames': ['Azacitidine'], 'description': 'Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection', 'armGroupLabels': ['CAR-T therapy']}, {'name': 'Venetoclax', 'type': 'DRUG', 'otherNames': ['ABT-199'], 'description': 'Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral', 'armGroupLabels': ['CAR-T therapy']}, {'name': 'CD19CD22 CAR-T', 'type': 'DRUG', 'otherNames': ['GDC-0199'], 'description': 'After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion', 'armGroupLabels': ['CAR-T therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xiaowen Tang, phD', 'role': 'CONTACT', 'email': 'xwtang1020@163.com', 'phone': '86-512-67781525'}, {'name': 'Depei Wu, PhD', 'role': 'CONTACT', 'email': 'wudepei@163.com', 'phone': '86-512-67781856'}], 'facility': 'Xiaowen Tang', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}