[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Daishi Tian\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,67,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100616298","early-phase-1-this-is-an-early-exploratory-study-to-assess-the-tolerability-and-safety-of-gc012f-in-patients-with-multiple-sclerosis-100616298",false,"NCT07303790","This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis","An Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n* 1\\. The laboratory test results at screening must meet the following criteria:\n\n  * a)Absolute neutrophil count ≥ 1.0 × 10\\^9\u002FL (no growth factor is given for supportive care within 7 days prior to testing);\n  * b)Absolute lymphocyte count ≥0.5×10\\^9\u002FL;\n  * c)Hemoglobin ≥ 80 g\u002FL (no red blood cell transfusion is given within 7 days prior to testing);\n  * d)Platelet count ≥ 50×10\\^9\u002FL (no blood transfusion is given within 7 days prior to testing);\n  * e)Serum IgG ≥ 500 mg\u002FdL;\n  * f)Activated partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN), prothrombin time (PT) ≤ 1.5 × ULN;\n  * g)Adequate renal, hepatic, cardiopulmonary function : i.Serum alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN; ii.Total bilirubin \\\u003C 2 × ULN (direct bilirubin ≤ 1.5 × ULN for subjects with Gilbert's syndrome); iii.Trial participants with left ventricular ejection fraction ≥ 45% (performed within 8 weeks prior to apheresis) as diagnosed by echocardiography (ECHO) or multi-gated acquisition scan and no evidence of pericardial effusion as determined by ECHO and no clinically significant electrocardiographic findings; iv.Oxygen saturation \\> 92% under indoor air conditions; v.Estimated glomerular filtration rate ≥ 60 mL\u002Fmin\u002F1.73 m\\^2.(CKD-EPI 2021 Formula).\n* 2.Confirmed diagnosis of MS based on the 2024 McDonald diagnostic criteria and diagnosis of relapsing or progressive MS based on the 2013 Lublin phenotype criteria for multiple sclerosis;\n\n  * Relapsing-remitting multiple sclerosis (RRMS):\n\n    1. patients with RRMS who have failed ≥ 1 highly effective disease modifying therapy (DMT) (fingolimod, siponimod, ozanimod, and anti-leukocyte cluster of differentiation \\[CD\\] 20 monoclonal antibody therapy, etc.) (defined as at least 12 months of continuous use).\n    2. At least 2 clinical relapses in the past 2 years, or 1 clinical relapse in the past 2 years with ≥ 1 new Gd-enhancing lesion on MRI, or ≥ 1 new Gd-enhancing lesion on MRI within the past 6 months; c) ≥ 2 Gd-enhancing lesions on T1-weighted brain MRI at screening.\n  * Primary progressive multiple sclerosis (PPMS):\n\n    1. patients with primary progressive MS who have failed highly effective DMT and whose disease activity has worsened recently (i.e., within 1 year) (EDSS disease progression score ≥ 0.5);\n    2. no Gd-enhancing lesions on brain MRI at screening.\n  * Secondary progressive multiple sclerosis (SPMS):\n\n    1. patients with secondary progressive MS who have failed highly effective DMT and whose disease activity has worsened recently (i.e., within 1 year) (EDSS disease progression score ≥ 0.5);\n    2. no Gd-enhancing lesions on brain MRI at screening.\n* 3.EDSS score ≥ 2.0 and ≤ 6.5;\n* 4.Documented history or confirmation at screening of the presence of oligoclonal bands or an elevated IgG index or the KFLC index in CSF.\n\nExclusion Criteria:\n\n* 1.Fungal, bacterial, viral, or other infection not controlled and\u002For requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening. Uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to current therapy;\n* 2.Active tuberculosis or latent tuberculosis that has not been treated appropriately prior to screening;\n* 3.History of severe hypersensitivity or allergy;\n* 4.Primary immunodeficiency;\n* 5.Impaired cardiac function or clinically significant cardiac disease;\n* 6.History of serious respiratory diseases or current serious respiratory diseases, including moderate or severe or above asthma or chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis;\n* 7.Current or history of cirrhosis;\n* 8.History of Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus within the past 2 years, and the need for continuous use of systemic immunosuppressants\u002Fsystemic disease-modifying drugs;\n* 9.Any active malignancy or history of malignancy within 5 years prior to screening. The following are exceptions: early-stage tumors that have undergone radical treatment (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth \\\u003C 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma in situ or early-stage thyroid cancer that has undergone radical treatment, cervical carcinoma in situ, or breast cancer in situ that has undergone potentially radical treatment;\n* 10.Those who have clinically significant bleeding symptoms or definite haemorrhagic diathesis within 6 months prior to screening;\n* 11.Arterial or venous thrombotic events such as cerebrovascular disorders (including cerebral hemorrhage, cerebral infarction, etc), deep venous thrombosis, and\u002For pulmonary embolism within 6 months prior to screening;\n* 12.Hematologic disorders: History of cytopenia consistent with myelodysplastic syndrome; history of sickle-cell anemia or other hemoglobinopathies;\n* 13.Severe underlying medical conditions, such as:\n\n  1. Significant clinical evidence of dementia or mental status changes;\n  2. History of any other central nervous system (CNS) disorders or neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis;\n  3. Mental disorders or psychosocial conditions that place patients at unacceptable risk.\n* 14.Positive results in any of the following tests:\n\n  1. Positive for human immunodeficiency virus (HIV) antibody;\n  2. Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with hepatitis B virus deoxyribonucleic acid (DNA) above the lower limit of detection of the assay;\n  3. Positive for hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) above the lower limit of detection of the assay;\n  4. Positive for antibodies against human T-cell lymphotropic virus types I and II;\n  5. Positive for syphilis antibody. As the immunosuppression included in this study may pose an unacceptable risk, those with active HIV infection, hepatitis B (positive for HBsAg), or HCV infection (positive for anti-HCV antibodies) are excluded. Subjects are allowed to have a previous history of hepatitis B or C, provided that viral load is shown to be below the limit of detection by quantitative polymerase chain reaction and\u002For nucleic acid testing. Hepatitis B surface antibodies produced following hepatitis B vaccination are not considered evidence of prior infection.\n* 15.Administration of a live attenuated vaccine within 4 weeks prior to apheresis;\n* 16.Receipt of a different investigational drug in a clinical trial within 4 weeks prior to apheresis, or the time interval from the last dose of the investigational drug in the previous drug clinical trial to the informed consent form (ICF) signing date is still within 5 half-lives of that drug (whichever is longer);\n* 17.Splenectomy within 12 months prior to the signing of ICF;\n* 18.Prior therapy targeting CD19 and\u002For BCMA, or CAR T product therapy against any target;\n* 19.Within 4 weeks prior to the apheresis, the trial participants had received treatment with targeted B-cell therapies, including but not limited to rituximab, ofatumumab, or orelizumab;\n* 20.Patients treated with siponimod and ozanimod within 1 month prior to apheresis;\n* 21.Patients treated with fingolimod within 6 weeks prior to apheresis;\n* 22.Patients treated with teriflunomide within 3 months prior to apheresis;\n* 23.Patients treated with dimethyl fumarate therapy within 2 weeks prior to apheresis;\n* 24.Major surgery within 8 weeks before the signing of ICF or planned surgery during the study (except for subjects scheduled for surgery under local anesthesia, provided that the surgery will not be performed within 2 weeks after infusion);\n* 25.Previous history of organ transplantation;\n* 26.History of neuromyelitis optica spectrum disorder or myelin oligodendrocyte glycoprotein antibody-related disease, or neurological diseases suspected of MS at screening;\n* 27.History of CNS or spinal cord tumors, metabolic or infectious spinal cord lesions, hereditary progressive CNS diseases, sarcoidosis, or non-MS progressive neurological diseases that interfere with study assessments;\n* 28.CNS disorders, such as cerebrovascular ischemia\u002Fhemorrhage, dementia, previous or current spinal cord lesions, cerebellar diseases unrelated to MS, or other diseases deemed by the investigator to potentially interfere with neurotoxicity assessment;\n* 29.History of seizures, even if seizures have been well controlled with antiepileptic drugs;\n* 30.MS lesions or symptoms that have the potential to increase the risk of neurotoxicity, including but not limited to tumor-like lesions (≥ 3 cm in diameter within 5 years prior to screening) or depressed level of consciousness, and\u002For the presence of active, clinically significant concomitant CNS pathological changes other than MS, which may impact interpretation of study results or complicate identification or assessment of neurotoxicity;\n* 31\\. Any contraindications to lumbar puncture (LP), including but not limited to:\n\n  1. Known or suspected structural abnormalities of the lumbar vertebra that, in the opinion of the investigator, may interfere with the conduct of LP or increase the risk of the procedure to the trial participant ;\n  2. Risk of increased or uncontrollable bleeding, including but not limited to vascular abnormalities or tumors at or around the LP site, coagulation cascade disorders, abnormal platelet function, or abnormal platelet counts;\n  3. Trial participants who are taking an anticoagulant (e.g., warfarin) or an antiplatelet agent (low-dose aspirin \\[100 mg\u002Fday or less\\] is permitted) do not meet the inclusion criteria unless the investigator considers it safe for the patient to temporarily discontinue the anticoagulant or antiplatelet therapy for LP;\n* 32.Trial participants who are unwilling or unable to undergo MRI per protocol requirements, such as those who are unable to undergo MRI due to claustrophobia, or those with clear contraindications to MRI (e.g., metal implants, metal foreign bodies in the body, cardiac pacemakers, defibrillators, etc.);\n* 33.Circumstances that, as judged by the investigator, may hinder the subject's full participation in the study or confuse the study results, or render participation in this study not in the trial participant's best interests.\n* 34.Based on the Columbia-Suicidality Severity Rating Scale (C-SSRS), participants have current suicidal intent, i.e., \"yes\" to question 4 (active suicidal ideation with intent to act but no specific plan) or question 5 (active suicidal ideation with specific plan and intent) on the C-SSRS or have a current history of suicidal behavior。","ALL","18 Years",{"count":19,"type":20},9,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.",[26],"Multiple Sclerosis",[26,28],"CAR-T cell therapy","RECRUITING","2026-05-19",{"date":32,"type":33},"2026-05-22","ACTUAL",{"date":35,"type":33},"2026-03-09",{"date":37,"type":20},"2028-12-10",{"name":39,"class":40},"Daishi Tian","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100633162","phase-1-a-study-on-the-safety-and-tolerability-of-universal-star-t-cell-therapy-for-multiple-sclerosis-100633162","NCT07523100","A Study on the Safety and Tolerability of Universal STAR-T Cell Therapy for Multiple Sclerosis.","A Clinical Study on the Safety and Tolerability of Universal STAR-T Cell Injection in Patients With Multiple Sclerosis.","Inclusion Criteria:\n\n* 1\\. Aged from 18 to 65 years (inclusive), with no gender restriction.\n* 2\\. Patients with MS who have been diagnosed according to the specified diagnostic criteria in the past and currently have no effective treatment options need to meet the following requirements, including:\n\n  1. According to the revised 2024 McDonald diagnostic criteria, they are clinically diagnosed with progressive MS (including primary progressive PPMS or secondary progressive SPMS) or relapsing-remitting MS (RRMS), and their disability status at the time of screening meets an EDSS score of 2-7 (inclusive).\n  2. For RRMS patients, they need to meet any of the following conditions: a) They have failed treatment with ≥1 effective DMT (fenogomide, cinemodide, ozamod, and anti-CD20 monoclonal antibody therapy, etc.); b) They have had at least 2 clinical relapses in the past 2 years, or they have had 1 clinical relapse in the past 2 years and MRI shows ≥1 new Gd-enhanced lesion, or they have had ≥1 new Gd-enhanced lesion on MRI within the past 6 months; c) There are ≥2 active Gd-enhanced lesions on T1-weighted brain MRI at the time of screening.\n* 3\\. The functions of important organs should meet the following requirements:\n\n  1. Bone marrow function should satisfy: a. Neutrophil count ≥ 1×109\u002FL (no colony-stimulating factor treatment within 2 weeks before the examination, and neutrophil reduction caused by the disease is excluded); b. Hemoglobin ≥ 60g\u002FL;\n  2. Liver function: ALT ≤ 3×ULN (ALT elevation caused by the disease can be excluded); AST ≤ 3×ULN (AST elevation caused by the disease can be excluded); TBIL ≤ 1.5×ULN (TBIL elevation caused by the disease can be excluded);\n  3. Kidney function: Creatinine clearance rate (CrCl) ≥ 30 ml\u002Fminute (Cockcroft\u002FGault formula, acute CrCl decline caused by the disease is excluded);\n  4. Coagulation function: International normalized ratio (INR) ≤ 1.5×ULN, prothrombin time (PT) ≤ 1.5×ULN;\n  5. Cardiac function: Good hemodynamic stability;\n* 4\\. For female subjects with reproductive capacity and their male partners, as well as male subjects whose female partners are of childbearing age, they are required to adopt medically approved contraceptive measures or abstain from sexual activity during the study treatment period and for at least 12 months after the end of the study treatment; female subjects of childbearing age must have a negative serum HCG test result within 7 days before study enrollment and must not be in the lactation period.\n* 5\\. Voluntarily participated in this clinical study, signed the informed consent form, had good compliance, and cooperated with the follow-up.\n\nExclusion Criteria:\n\nIf the subjects meet any of the following exclusion criteria, they will not be included in this study:\n\n* 1\\. The period of using immunosuppressants with therapeutic effects on the disease before enrollment is within five half-lives or the biological agents have been used for 4 weeks. For subjects who have received rituximab treatment, the time since the last use of rituximab is less than 3 months (except for those with B-cell reconstitution);\n* 2\\. Have a severe history of drug allergy or are allergic constitution;\n* 3\\. Have uncontrollable or require treatment infections such as fungi, bacteria, viruses, etc.;\n* 4\\. Have active tuberculosis at the time of screening;\n* 5\\. Have heart dysfunction (NYHA cardiac function classification \\> grade II) and cannot tolerate the study's lymphocyte purification and cell reinfusion.\n* 6.Subjects with congenital immunoglobulin deficiencies;\n* 7\\. Subjects with a history of unremitting malignant tumors within the past five years;\n* 8\\. Subjects with end-stage renal failure;\n* 9\\. Subjects with positive hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and peripheral blood HBV DNA titer higher than the detection limit; subjects with positive hepatitis C virus (HCV) antibody and positive HCV RNA in peripheral blood; subjects with positive human immunodeficiency virus (HIV) antibody; subjects with positive syphilis test results;\n* 10\\. Male and female subjects who are pregnant or have a fertility plan during the participation in this study or within 2 years after receiving study treatment;\n* 11\\. Subjects that the researchers consider have other reasons that prevent them from being included in this study.","65 Years",{"count":51,"type":20},24,[53],"PHASE1","This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.\n\nThe main objective is to explore the safety and tolerability of the universal STAR-T cell injection in patients with progressive or relapsing-remitting multiple sclerosis (MS).The secondary objectives are to evaluate the efficacy of the universal STAR-T cell injection in treating patients with progressive or relapsing-remitting MS; and to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection.\n\nThe primary endpoint of this study is the incidence rate of dose-limiting toxicity (DLT), as well as the types, severity and frequency of adverse events (AE).The secondary research endpoints of this study are the efficacy endpoints as well as the expansion and persistence of the universal STAR-T cells in the body.\n\nThis study is an exploratory clinical trial of the universal STAR-T cell injection for the treatment of progressive or relapsed-remitting MS. The study will be conducted in two phases: dose escalation and dose expansion. The dose escalation group 1 (1.5E6 STAR-T cells) begins, followed by dose escalation group 2 (3E6 STAR-T cells), and dose escalation group 3 (4.5E6 STAR-T cells).\n\nExpansion study phase: After the dose escalation stage is completed, based on the safety, PK results and preliminary efficacy data of each dose group during the escalation stage, the recommended dose will be determined for the dose expansion study. It is planned to include 3 to 6 subjects to further systematically evaluate the safety and efficacy of the universal STAR-T cell.\n\nThis study includes the screening period (from D-28 to D-6), the pre-clearance treatment and rest observation period (from D-5 to D-1), the cell infusion and main study endpoint observation period (from D0 to W12 after infusion), and the follow-up period (from W12 after infusion to W104).",[56],"Multiple Sclerosis (MS)",[26],"NOT_YET_RECRUITING","2026-04-04",{"date":61,"type":33},"2026-04-13",{"date":63,"type":20},"2026-04-07",{"date":65,"type":20},"2029-04-01",{"name":39,"class":40},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":41},"100599585","early-phase-1-gc012f-injection-in-refractory-idiopathic-inflammatory-myopathy-100599585","NCT07086404","GC012F Injection in Refractory Idiopathic Inflammatory Myopathy","Early Exploratory Clinical Study of GC012F Injection in Refractory Idiopathic Inflammatory Myopathy","Inclusion Criteria:\n\n* 1\\) The subject or his\u002Fher legally acceptable representative voluntarily signs the written informed consent form and is willing and able to comply with the procedures of this study; 2) Aged 18 to 70 years (inclusive) at the time of signing informed consent, male or female; 3) Patients should meet the following criteria:\n\n  1. Subjects with suspected or confirmed idiopathic inflammatory myopathy (IIM) based on the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria and at least one proximal limb muscle strength of less than or equal to Grade 4; patients with immune-mediated necrotizing myopathy (IMNM) may be included if he\u002Fshe meets other inclusion criteria and does not meet all exclusion criteria and the investigator assesses that the patient has no safety instability;\n  2. Active myositis on muscle biopsy or muscle magnetic resonance imaging (MRI) within the screening period or within 6 months prior to screening;\n  3. Positive (+ or above) for at least one myositis-specific antibody (MSA) or myositis-associated antibody (MAA) (including anti-TIF-1γ, NXP-2, Mi-2α, Mi-2β, MDA-5, SAE-1\u002F2, SRP, HMGCR, Jo-1, PL-7, PL-12, HA, EJ, OJ, KS, Zo, PM-Scl100, PM-Scl75, SSA\u002FRo-52, SSB\u002FLA, Ku, RNA-PIII, cN1A, etc.);\n  4. At screening, the subject must have moderate to severe IIM, defined as manual muscle testing (MMT) \\\u003C 142 and 2 of the following criteria are met:\n\n     * PGA (VAS) ≥ 2 cm (VAS 10 cm scale);\n     * PtGA (VAS) ≥ 2 cm (VAS 10 cm scale);\n     * Health assessment questionnaire (HAQ) \\> 0.25;\n     * Increase in one or more muscle enzymes (CK, LDH, AST, ALT) is ≥ 1.5 × ULN;\n     * Extramuscular global assessment (Myositis Disease Activity Assessment Tool \\[MDAAT\\]) ≥ 2.0 cm (VAS 10 cm scale); 4) Muscle enzyme increased (CK) ≥ 2 × ULN; 5) Inadequate response or intolerance to corticosteroids and at least 2 immunosuppressants and\u002For biologic agents; 6) If the patient is taking corticosteroids, the dose of prednisone should not exceed 40 mg\u002Fday (or equivalent dose of other corticosteroids) within 3 weeks before apheresis, and the dose is not uptitrated within 3 weeks before apheresis and not changed within 4 weeks before infusion (Note: under the premise that the subject's disease under study is controlled, the investigator may consider reducing the dose of corticosteroids before apheresis, lymphodepletion, and infusion); 7) Life expectancy ≥3 months; 8) Laboratory test results must meet the following criteria at screening (except for those related to the corresponding disease under study):\n\n  \u003C!-- -->\n\n  1. Neutrophil count \\> 1.0 × 10\\^9\u002FL, Hemoglobin ≥ 80g\u002FL, platelet count ≥ 50 × 10\\^9\u002FL;\n  2. Alanine aminotransferase ≤ 3 × upper limit of normal (ULN); aspartate aminotransferase ≤ 3 × ULN (unless the increases in alanine aminotransferase and\u002For aspartate aminotransferase are assessed by the investigator as related to polymyositis \\[PM\\] or dermatomyositis \\[DM\\]); total bilirubin (TBIL) \\\u003C 2 × ULN (direct bilirubin \\[DBIL\\] ≤ 1.5 × ULN for subjects with Gilbert's syndrome);\n  3. Creatinine clearance ≥ 60 ml\u002Fmin;\n  4. Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;\n  5. Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiogram, with no evidence of pericardial effusion as determined; 9) Women of childbearing potential must:\n\n  \u003C!-- -->\n\n  1. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening as confirmed by the investigator;\n  2. Agree to avoid breastfeeding during the study period and until at least 2 years after infusion of GC012F Injection, or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later); 10) Male subjects with sexual partners and female subjects of childbearing potential must agree to use highly effective contraception methods (e.g., oral contraceptives, intrauterine devices, or condoms) starting from screening and continuing for at least 2 years after GC012F Injection infusion or until two consecutive flow cytometry tests indicate that CAR-T cells are no longer present (whichever occurs later). Male subjects must agree to use condoms during any sexual contact with pregnant women or women of childbearing potential for at least 2 years after GC012F Injection infusion, even if they have undergone successful vasoligation.\n\n     11\\) The required venous access for collection can be set up, with no contraindications for leukapheresis.\n\n     Exclusion Criteria:\n* 1\\) Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor-related PM or DM, amyopathic DM, non-inflammatory myopathy (e.g., muscular dystrophy); for patients with PM or DM, they were \\> 40 years of age at onset of PM or DM symptoms and the diagnosis time is less than 3 years, and the investigator considered a possible malignancy based on the patient's clinical presentation; 2) Uncontrolled extramuscular disease impairment associated with PM or DM:\n\n  1. Interstitial lung disease (ILD): Forced vital capacity (FVC) \\\u003C 55% or requiring oxygen therapy;\n  2. Severe dysphagia manifestations, that will increase the risk associated with the patient's participation in the clinical trial, as judged by the investigator;\n  3. Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, conduction abnormality requiring treatment or myocardial infarction) that, in the judgment of the investigator, will increase the risk associated with the patient's participation in the clinical trial; 3) Patients with severe muscle injury who meet one of the following criteria:\n\n  \u003C!-- -->\n\n  1. Myositis damage index (MDI) ≥ 5;\n  2. Severe proximal muscle atrophy of the upper or lower extremities as shown on MRI;\n  3. Severe proximal muscle atrophy of the upper or lower extremities as found by clinical examinations; 4) History of severe hypersensitivity or allergy; 5) Contraindications or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product; 6) Presence of the following cardiac disorders:\n\n  \u003C!-- -->\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n  2. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening;\n  3. History of clinically significant ventricular arrhythmia or unexplained syncope not due to a vasovagal reaction or dehydration, or QTc interval \\> 480 milliseconds at screening;\n  4. History of severe non-ischemic cardiomyopathy; 7) Any active malignancy or history of malignancy within 5 years prior to screening. Exceptions include curatively treated early stage tumors (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth of less than 1 mm and no involvement of lymph nodes), cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, in-situ carcinoma of cervix, or in-situ carcinoma of breast that has been potentially curatively treated; 8) Clinically significant hemorrhage symptoms or a definite tendency to hemorrhage within 6 months prior to screening, such as hemorrhage of digestive tract and hemorrhagic gastric ulcer; hereditary or acquired hemorrhage or thrombotic tendencies (e.g., hemophilia, coagulation disorders, and hypersplenism); arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), deep vein thrombosis and\u002For pulmonary embolism; 9) Severe underlying medical conditions such as:\n\n  \u003C!-- -->\n\n  1. Evidence of viral, bacterial, fungal, or other infections that are uncontrolled or need systemic intravenous treatment;\n  2. Clear clinical evidence of dementia or altered mental status;\n  3. Any other central nervous system disease or history of neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis; 10) Any of the following test results is positive:\n\n  \u003C!-- -->\n\n  1. Human immunodeficiency virus (HIV) antibody positive;\n  2. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) -DNA above the lower limit of detection of the assay;\n  3. Hepatitis C virus (HCV) antibody positive and HCV RNA above the lower limit of detection of the assay;\n  4. Syphilis antibody positive; 11) Active tuberculosis or latent tuberculosis that has not been treated appropriately prior to screening; 12) Receipt of other investigational products within 4 weeks prior to signing the ICF, or if the time from the last dose of a previous investigational product to the ICF signing date is still within 5 half-lives of that drug (whichever is longer); 13) Thymectomy within 12 months prior to signing the ICF; 14) Receipt of drugs targeting B cells within 3 months prior to signing of the ICF; 15) Receipt of other biologic agents within 3 weeks prior to apheresis or within 8 weeks prior to infusion; 16) Major surgery within 8 weeks prior to signing the ICF, or planned surgery during the study; 17) History of organ transplantation; 18) Prior therapy targeting cluster of CD19 and\u002For BCMA-targeted therapy, or CAR-T product therapy targeting any antigen; 19) Pregnant women, breastfeeding women who do not agree to discontinue breastfeeding, or males and females who plan to conceive during the study or within 1 years after receiving study treatment; 20) Any condition, as determined by the investigator, that would interfere with the subject's full participation in the study, confound the study results, or render participation in the study not in the best interest of the subject.","70 Years",{"count":76,"type":20},12,[23],"This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with refractory idiopathic inflammatory myopathy and to assess the pharmacokinetic and pharmacodynamic profiles.\n\nThis study consists of screening period, apheresis period, baseline period, lymphodepleting preconditioning period, pre-infusion evaluation period, CAR-T cell infusion period and follow-up period.\n\nEligible subjects will undergo apheresis and receive infusion following the manufacture of the CAR-T product. Subjects will receive lymphodepleting preconditioning before CAR-T cell infusion and will be assessed before infusion. If the criteria for cell infusion are met, CAR-T cell infusion will be performed and the infusion dose in the same group or subsequent treatment groups may be adjusted according to the safety and clinical response.\n\nA total of 1 dose group will be set for CAR-T cell infusion dose in this study: 3 × 10\\^5\u002Fkg. Approximately 12 subjects are planned to be enrolled. Subjects will be monitored for dose-limiting toxicity (DLT) within 28 days following the infusion of GC012F Injection. For the first 3 patients receiving infusions of GC012F, 3 additional patients will be included in this cohort if no more than 1\u002F3 of the patients experience DLTs at a given dose level. If 2\u002F3 or more DLTs occur at this dose level, a spare dose of 2.0 × 10\\^5\u002Fkg or 1.0 × 10\\^5\u002Fkg may be administered to subsequent subjects following discussion between the investigator and the partner. If no more than 1 out of the first 6 subjects experiences a DLT, 6 additional subjects will be enrolled. Once 2 subjects experience DLTs, the investigator and the partner will discuss and decide whether to use a spare dose group of 2.0×10\\^5\u002Fkg or 1.0×10\\^5\u002Fkg.\n\nAfter the first 3 subjects have all completed the 28-day DLT observation period, the Safety Monitoring Committee (SMC) will conduct an assessment based on clinical safety and pharmacokinetic data (if available). Subsequently, the SMC may, depending on the safety profile and study progress, request an increased frequency of safety committee assessments and reviews. After completing the DLT observation period for all subjects in this dose group, all clinical study data collected during the DLT observation period for this dose group, especially safety data, will be assessed, and whether to add new subjects to this dose group and whether to explore a different dose group will be decided upon discussion between the investigator and the partner.\n\nFollowing CAR-T cell infusion, subjects will be followed for safety, cell proliferation and survival, and efficacy until the subject withdraws from the study and refuses subsequent follow-up, or dies, or withdraws consent, or is lost to follow-up, whichever occurs first.",[80],"Idiopathic Inflammatory Myopathy (IIM)","2026-01-12",{"date":83,"type":33},"2026-01-14",{"date":85,"type":33},"2025-09-15",{"date":87,"type":20},"2029-09-15",{"name":39,"class":40},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":41},"100597423","early-phase-1-gc012f-injection-in-the-treatment-of-refractory-generalized-myasthenia-gravis24103-100597423","NCT07058298","GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)","An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis","Inclusion Criteria:\n\n* To be enrolled, subjects must meet all of the following criteria:\n\n  1. Subjects or their legal representatives voluntarily sign a written informed consent and are willing and able to comply with the procedures of the study;\n  2. Subjects aged 18-75 years old (both inclusive), male or female;\n  3. Subjects with confirmed refractory gMG of classes IIa - IVb by MGFA clinical classification (including classes IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;\n  4. Subjects with the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of ≥6, the proportion of ocular symptoms of \\\u003C50% of the total score, and the Quantitative Myasthenia Gravis (QMG) score of ≥11;\n  5. Subjects with poor response and\u002For who do not respond to the conventional therapies, that means subjects who are still at risk of relapse or exacerbation after conventional therapies with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);\n  6. For patients who are taking corticosteroids, the dose of prednisone should not exceed 30 mg\u002Fday (or an equivalent dose of other corticosteroids), and the dose must be stable for at least 4 weeks before infusion;\n  7. The laboratory test results during the screening period meet the following criteria:\n\n     1. Neutrophil count ≥ 1.0×10\\^9\u002FL; Hemoglobin ≥ 8.0 g\u002FdL; Platelet count≥50×10\\^9\u002FL;\n     2. Alanine aminotransferase ≤ 3× upper limit of normal (ULN); Aspartate aminotransferase ≤ 3×ULN; total bilirubin (TBIL) \\\u003C 2× ULN (for subjects with Gilbert's syndrome), direct bilirubin (DBIL)) ≤ 1.5×ULN\n     3. Creatinine clearance (19.3 Appendix 3) ≥ 30 mL\u002Fmin;\n     4. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT)≤ 1.5×ULN;\n     5. Subject's left ventricular ejection fraction (LVEF) is ≥ 50% by echocardiography, with no evidence of pericardial effusion as determined;\n  8. Female subjects of child-bearing age must:\n\n     1. At screening, a negative serum β human chorionic gonadotropin β-hCG pregnancy test result confirmed by the investigator;\n     2. Who agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).\n  9. Male subjects with sexual partners and female subjects of potential child-bearing age shall agree to take effective contraceptive measures (e.g., oral contraceptive pills, intrauterine device or condom) from the screening period until at least 2 years after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later). Male subjects must agree to use condoms during sexual contact with pregnant women or females of child-bearing age within at least 2 years after the infusion of GC012F Injection, even if a successful vasectomy has been performed;\n  10. Subjects for whom venous access available for blood collection can be established, and with no contraindications to leukocyte collection.\n\nExclusion Criteria:\n\n* Participants who meet any of the following criteria are not included in the study:\n\n  1. Have a history of severe hypersensitivity or allergy;\n  2. Contraindications or hypersensitivity to fludarabine, cyclophosphamide and any component of the test drug;\n  3. Subjects who have received intravenous immunoglobulin or plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to infusion;\n  4. Received CD20-targeted drugs within 6 months prior to apheresis;\n  5. Received Tacrolimus, Cyclosporine, Azathioprine, Mycophenol Mofetil within 1 week before apheresis;\n  6. Treatment with neonatal Fc receptor (FcRn) antagonists within 1 week prior to apheresis;\n  7. Patients who have received complement inhibitors (e.g., eculizumab, etc.) within 1 weeks before apheresis ;\n  8. Subjects with any of the following heart diseases:\n\n     1. Class III or Class IV congestive heart failure based on New York Heart Association (NYHA) Functional Classification;\n     2. Unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening;\n     3. Clinically significant ventricular arrhythmia or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \\>480 ms at screening;\n     4. Has a history of severe non-ischemic cardiomyopathy;\n     5. Severe cardiovascular abnormalities (such as brain natriuretic peptide (BNP)\u002Ftroponin and other indices) and the investigator judges that such subjects are not eligible for enrollment.\n  9. Subjects with other uncontrolled malignancies. The following conditions will be excluded: early-stage tumors that have been treated by radical surgery (carcinoma in situ or grade 1 tumors, or non-ulcerative primary melanoma with a depth of \\\u003C1 mm and with no involvement of lymph nodes), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has been treated by potential radical treatment;\n  10. Serious underlying medical conditions, such as:\n\n      1. Viral, bacterial, fungal, or other infections that are uncontrollable or requiring systemic intravenous therapy (including tuberculosis infection with clear evidence of disease activity) as demonstrated by evidence;\n      2. Dementia or mental status changes as demonstrated by significant clinical evidence;\n      3. History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., Epilepsy, Convulsion, Paralysis, Aphasia, Stroke, Severe brain injury, Dementia, Parkinson's disease, Mental Illness).\n  11. Positive result for any of the following tests:\n\n      1. Positive test result of human immunodeficiency virus (HIV) antibody;\n      2. Positive test result of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (HBV DNA copy number will be detected for HBcAb- or HBsAb-positive patients. If the copy number is lower than the lower limit of detection, patients can be enrolled under the premise of standardized antiviral therapy);\n      3. Positive test result of hepatitis C virus (HCV) antibody with the copy number of HCV RNA higher than the lower limit of detection; or with known history of hepatitis C without completion of antiviral therapy for ≥24 weeks;\n      4. Positive test result of Syphilis antibody.\n  12. Prior treatment with a CAR-T product for any target;\n  13. Previous organ or allogeneic bone marrow transplantation;\n  14. Subjects who have undergone surgery within 2 weeks prior to lymphodepletion pretreatment or plan to undergo surgery during the study (except subjects who schedule for local anesthesia surgery, but the surgery cannot be performed within 2 weeks after infusion);\n  15. Received live attenuated vaccine within 4 weeks prior to lymphodepletion pretreatment;\n  16. Subjects who have received study drugs in other clinical trials within 4 weeks prior to signing the informed consent form, or whose ICF signing date is within 5 half-lives of the last dose they had taken in other clinical trial (whichever is longer);\n  17. Pregnant females or lactating females who do not agree to give up breastfeeding, during the period of participation in this study or men with a family plan within 1 year of receiving study treatment and females;\n  18. Subjects with suicidal intentions at present based on the Columbia-Suicide Severity Rating Scale (C-SSRS), i.e., the answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on \"Suicide\" in the C-SSRS is \"Yes\", or who have a history of suicidal behavior at present;\n  19. According to the researcher's judgment, there are circumstances that may prevent the subject from participating in the full trial, confuse the trial results, or participation in this study is not in the best interests of subjects.","75 Years",{"count":98,"type":20},6,[23],"This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.",[102],"Generalized Myasthenia Gravis (gMG)","2025-09-05",{"date":105,"type":33},"2025-09-08",{"date":107,"type":33},"2025-07-15",{"date":109,"type":20},"2027-09-10",{"name":39,"class":40},""]