Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-28 @ 10:39 PM
Study NCT ID:
NCT06770504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-13
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000744', 'term': 'Anemia, Hemolytic, Autoimmune'}], 'ancestors': [{'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity', 'timeFrame': 'Within 28 days after infusion'}, {'measure': 'The incidence and frequency of treatment-emergent adverse events', 'timeFrame': 'Within 12 months after infusion', 'description': 'Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.'}, {'measure': 'Best overall response rate (BOR) of each dose group', 'timeFrame': 'Within 12 weeks after infusion', 'description': 'BOR is determined as the most favorable response observed after cell infusion, until either disease relapse or the completion of a specified observation period.'}, {'measure': 'Objective response rate (ORR) of each dose group', 'timeFrame': 'Within 4 weeks after infusion'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Within 6 months after infusion', 'description': 'TTR is defined as the duration from cell infusion to the achievement of a hematological response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed/Refractory Autoimmune Hemolytic Anemia', 'CD19-STAR T cells'], 'conditions': ['Autoimmune Hemolytic Anemia', 'Anti-CD19 STAR T-cell Therapy', 'Failure ≥3 Lines of Therapies']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥12 years, regardless of gender.\n* Diagnosis of AIHA or Evans syndrome \\[including warm antibody, mixed AIHA and cold antibody AIHA (Cold agglutinin disease)\\].\n* Failure or intolerance to at least 3 lines of therapy: glucocorticoids and/or rituximab, and any one of the following treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, etc.Biologics, including anti-CD38 monoclonal antibody, BTK inhibitor, Syk inhibitor and complement inhibitor) (HGB \\< 100g/L).\n* Adequate organ function: a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. b. Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥60ml/min. c.Blood oxygen saturation (SpO2) ≥92%.\n* ECOG performance status≤2\n* Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 12-month safety follow-up period.\n* The subjects voluntarily participate in the study, sign the informed consent, demonstrate good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Diagnosis of lymphoproliferative tumor\n* Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)\n* The platelet count in peripheral blood\\<30×10\\^9/L\n* Pregnant or breast-feeding subjects\n* Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \\<12 weeks, b.sutimlimab or other marketed biologics \\<5 half-lives,c.plasma exchange \\<4 weeks, d.post-splenectomy \\<12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \\< 5 half-lives.\n* Previously received organ or stem cell transplantation\n* History of new thrombosis or organ infarction in the past 6 months\n* Diagnosis of the active stage of the connective tissue disease.\n* Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.\n* Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.\n* Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.\n* Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.\n* Have a history of live attenuated vaccines within 6 weeks before enrollment.\n* Have a history of epilepsy or other active central nervous system diseases.\n* Have an allergy to the ingredients of the medicine used in this study.\n* Previously received CAR-T cell therapy.\n* Patients considered to be ineligible for the study by the investigator for reasons other than the above.'}, 'identificationModule': {'nctId': 'NCT06770504', 'briefTitle': 'A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'The Safety and Efficacy of YTS109 Cell Injection for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.', 'orgStudyIdInfo': {'id': 'YTS109-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YTS109', 'description': 'Participants will receive YTS109 cell infusion after preconditioning, and they need to be closely monitored for 24 hours following START-T cell infusion.', 'interventionNames': ['Biological: YTS109']}], 'interventions': [{'name': 'YTS109', 'type': 'BIOLOGICAL', 'description': 'In this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once.', 'armGroupLabels': ['YTS109']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lele Zhang, PhD', 'role': 'CONTACT', 'email': 'zhanglele@ihcams.ac.cn', 'phone': '13752253515'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Immunotech (Beijing) Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Red Blood Cell Disorders Center & Director of the Regenerative Medicine Clinic', 'investigatorFullName': 'Jun Shi', 'investigatorAffiliation': 'Institute of Hematology & Blood Diseases Hospital, China'}}}}