CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jan 22, 2024

Nctid: NCT06231368

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000740", "term"=>"Anemia"}, {"id"=>"D000000743", "term"=>"Anemia, Hemolytic"}, {"id"=>"D000000744", "term"=>"Anemia, Hemolytic, Autoimmune"}, {"id"=>"D000006461", "term"=>"Hemolysis"}], "ancestors"=>[{"id"=>"D000006402", "term"=>"Hematologic Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M4070", "name"=>"Anemia", "asFound"=>"Anemia", "relevance"=>"HIGH"}, {"id"=>"M9547", "name"=>"Hemolysis", "asFound"=>"Hemolytic", "relevance"=>"HIGH"}, {"id"=>"M4073", "name"=>"Anemia, Hemolytic", "asFound"=>"Hemolytic Anemia", "relevance"=>"HIGH"}, {"id"=>"M4074", "name"=>"Anemia, Hemolytic, Autoimmune", "asFound"=>"Autoimmune Hemolytic Anemia", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"T557", "name"=>"Autoimmune Hemolytic Anemia", "asFound"=>"Autoimmune Hemolytic Anemia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>6}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-02", "completionDateStruct"=>{"date"=>"2025-08-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-02-03", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-06", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-31", "type"=>"ESTIMATED"}}, "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 antibody 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"=>"HY001010"}}, "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", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Lele Zhang, PhD", "role"=>"CONTACT", "email"=>"zhanglele@ihcams.ac.cn", "phone"=>"15811139278‬"}], "facility"=>"Regenerative Medicine Center", "geoPoint"=>{"lat"=>39.14222, "lon"=>117.17667}}], "centralContacts"=>[{"name"=>"Jun Shi, PhD", "role"=>"CONTACT", "email"=>"shijun@ihcams.ac.cn", "phone"=>"13752253515"}, {"name"=>"Jingyu Zhao, MPH", "role"=>"CONTACT", "email"=>"zhaojingyu@ihcams.ac.cn"}]}, "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"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Director of Regenerative Medical Center", "investigatorFullName"=>"Jun Shi", "investigatorAffiliation"=>"Institute of Hematology & Blood Diseases Hospital, China"}}}}