Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-05 @ 3:13 AM
Study NCT ID:
NCT06514768
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2024-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JY231(JY231) Injection for the Treatment of B-cell 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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2024-07-18', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment Related adverse events (AEs)', 'timeFrame': 'Up to 12 months after infusion', 'description': 'The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 24 weeks after infusion', 'description': 'Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 24 weeks after infusion', 'description': 'Overall survival (OS) is the time from randomization to death from any cause.'}, {'measure': 'Duration of remission (DOR)', 'timeFrame': 'Up to 24 weeks after infusion', 'description': 'Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'At 2,4,8 and 12 weeks after infusion', 'description': 'Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Acute Lymphoblastic Leukemia( B-ALL )']}, 'descriptionModule': {'briefSummary': 'Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia( B-ALL )'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE)；\n2. Histologically confirmed as B cell ALL ;\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \\< 34 μ Mol/L; Creatinine clearance rate\\>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)\\>30 × 109/L, Hb\\>80 g/L, with a single venous access and no other contraindications for blood cell separation;\n8. MRI examination showed no central involvement of lymphoma; No central nervous system leukemia;\n9. Individuals with fertility must agree to the use of efficient contraceptive methods;\n10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants."}, 'identificationModule': {'nctId': 'NCT06514768', 'briefTitle': 'JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)', 'organization': {'class': 'OTHER', 'fullName': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"}, 'officialTitle': 'JY231 Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL ) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy', 'orgStudyIdInfo': {'id': 'JY-CT-23-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JY231 injection for the treatment of B-cell acute lymphoblastic leukemia( B-ALL )', 'interventionNames': ['Biological: JY231']}], 'interventions': [{'name': 'JY231', 'type': 'BIOLOGICAL', 'description': 'Infusion of JY231 Injection by dose of 1-10×10\\^6 Transduction Units(TU)/ kg、1-5×10\\^7 TU/kg、5-10 ×10\\^7 TU/kg. Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)', 'armGroupLabels': ['JY231 injection for the treatment of B-cell acute lymphoblastic leukemia( B-ALL )']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'facility': '920th HJointLogistics', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Sanbin Wang, Doctor', 'role': 'CONTACT', 'email': 'sanbin1011@163.com', 'phone': '13187424131', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Sanbin Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}