Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-31 @ 1:10 AM
Study NCT ID:
NCT06747156
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2024-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence, severity, and nature of treatment-emergent adverse events (TEAE)s.', 'timeFrame': 'from the first dose of study treatment to 30 days after the last dose of study treatment.'}, {'measure': 'The incidence, severity, and nature of serious TEAEs (TESAE)s .', 'timeFrame': 'from the first dose of study treatment to 30 days after the last dose of study treatment.'}, {'measure': 'The incidence, severity, and nature of TEAEs leading to interruption or early termination of study treatment.', 'timeFrame': 'from the first dose of study treatment to 30 days after the last dose of study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of mRNA encoding CD19/CD3 T cell engager (ABO2203) in patients with refractory autoimmune diseases who received inadequate response or relapsed from standard of care (SoC). The trial included dose escalation and dose expansion parts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years of age at time of informed consent.\n2. Diagnosis of autoimmune diseases according to the corresponding disease classification criteria.\n3. Inadequate response to SoCs or relapsed after the treatment.\n4. Patients were on a stable dose of SoCs for at least 4 weeks prior to enrollment.\n5. Sufficient organ function.\n\nExclusion Criteria:\n\n1. Active infection, including tuberculosis, active or relapsed peptic ulcer, etc.\n2. Severe hypogammaglobulinemia or IgA deficiency.\n3. Active hepatitis or with a history of severe liver disease.\n4. History of rapid allergic reactions, eczema or asthma that cannot be controlled by topical corticosteroids.\n5. Severe cardiovascular diseases.\n6. History of cancer within past 5 years.\n7. Have other serious medical conditions.\n8. Received any of B cell targeted therapies and biologic therapies within the defined time window.\n9. History of severe allergies or known allergies to any active or inactive component of the study drug(s).\n10. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.'}, 'identificationModule': {'nctId': 'NCT06747156', 'briefTitle': 'A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Clinical Study to Investigate Safety, Tolerability, and Preliminary Efficacy of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Refractory Autoimmune Diseases', 'orgStudyIdInfo': {'id': 'ABO2203-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABO2203', 'interventionNames': ['Drug: ABO2203 Injection']}], 'interventions': [{'name': 'ABO2203 Injection', 'type': 'DRUG', 'description': 'Name of Active Ingredient: mRNA encoding CD19/CD3 T cell engager', 'armGroupLabels': ['ABO2203']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chengde Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qiongyi Hu', 'role': 'CONTACT', 'email': 'huqiongyi131@163.com', 'phone': '18317071395'}], 'overallOfficials': [{'name': 'Chengde Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abogen Life Sciences (Shanghai) Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}