Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2026-01-04 @ 9:34 AM
Study NCT ID:
NCT06231368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2024-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.
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': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2024-01-22', 'studyFirstSubmitQcDate': '2024-01-22', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and the severity of the adverse event', 'timeFrame': 'Within 12 months', 'description': 'Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with hematological response', 'timeFrame': 'Within 24 weeks', 'description': 'Hematological response is mainly evaluated by hemoglobin (Hb), laboratory Indicators of hemolysis (serum bilirubin and lactate dehydrogenase) and blood transfusion.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autoimmune Hemolytic Anemia', 'CNCT19 CAR T-Cell therapy'], 'conditions': ['Autoimmune Hemolytic Anemia', 'Autologous CD19 CAR-T', 'Failure of Three or More Lines of Therapy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, single-arm, open-label, dose-escalation and dose-expansion study. The main purpose is to evaluate the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with autoimmune hemolytic anemia after failure of three or more lines of therapy. Participants will receive CNCT19 cell infusion after preconditioning, and they will receive a 1-year follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject and/or subject's legal personal representative fully understand and voluntarily sign informed consent forms\n* Male or female age ≥ 12 years\n* Subjects with autoimmune hemolytic anemia or Evans syndrome after Failure ≥3 lines of therapy. The Failure of ≥3 lines of therapy meets all the following conditions: Hemoglobin less than 10g/dl and symptoms of anemia; Failure of first-line corticosteroid therapy; Failure of second-line rituximab therapy; Failure of any one or more of the third-line treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, fludarabine, bortezomib, etc.)\n* Female subjects of childbearing potential must have a negative Serum HCG test within 7 days before enrollment. Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the 1-year follow-up after cell infusion\n* Laboratory tests of adequate organ function: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; and have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and the blood oxygen saturation in a non-oxygenated state is \\>93%\n* ECOG performance status ≤2\n* Subject with a life expectancy of more than 3 months\n\nExclusion Criteria:\n\n* History of other lymphoproliferative neoplasms\n* Secondary AIHA caused by drugs or infection\n* Platelets in subjects with Evans syndrome\\<30×10\\^9/L\n* Pregnant or breast-feeding subjects\n* Treatment with any of the following within the noted period prior to study entry: 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\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* Had other inherited or acquired hemolytic diseases\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* Received major surgery within 4 weeks before screening that was assessed by the researcher as 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 (except atrial fibrillation, paroxysmal supraventricular tachycardia), d.QTcB interval ≥450ms for men and ≥470ms for women, e.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, f.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* Participate in other interventional clinical studies during CNCT19 CAR T-Cell therapy, and the drug has a half-life of \\<5. Subjects treated with active investigational drugs or intend to participate in another clinical trial or receive treatment other than that specified in the protocol throughout the study period\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': 'NCT06231368', 'briefTitle': 'CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': 'The Safety and Efficacy of CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure of Three or More Lines of Therapy', 'orgStudyIdInfo': {'id': 'IIT2024003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CNCT19 CAR T-Cell Therapy', 'description': "Participants will receive CNCT19 cell infusion after preconditioning, and they need to be closely monitored for 24 hours following CAR-T cell infusion. Participants are advised to remain in the hospital for a minimum of 14 days following cell infusion. The duration of hospitalization and observation will be determined based on the researcher's comprehensive assessment of the subject's condition.", 'interventionNames': ['Biological: CNCT19 CAR-T cell therapy']}], 'interventions': [{'name': 'CNCT19 CAR-T cell therapy', 'type': 'BIOLOGICAL', 'description': 'CNCT19 was a second-generation CAR T-cell with scFv derived from clone HI19α and 4-1BB/CD3-ζ costimulatory domain.', 'armGroupLabels': ['CNCT19 CAR T-Cell Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Regenerative Medicine Center', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Juventas Cell Therapy Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}