[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Grit Biotechnology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":404},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,40,62,84,107,130,153,172,191,211,228,245,266,285,305,325,344,365,384],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644928","early-phase-1-a-clinical-study-to-investigate-the-safety-and-efficacy-of-off-the-shelf-inkt-cell-injection-targeting-cd33cd70-in-adult-patients-with-relapsedrefractory-acute-myeloid-leukemia-100644928",false,"NCT07676006","A Clinical Study to Investigate the Safety and Efficacy of Off-the-Shelf iNKT Cell Injection Targeting CD33\u002FCD70 in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in this clinical study, fully understand the study content, sign the informed consent form, and be willing to comply with all study procedures and complete all follow-up visits.\n* 2\\. Aged between 18 and 75 years old (inclusive), with no restriction on gender.\n* 3\\. Confirmed diagnosis of relapsed\u002Frefractory acute myeloid leukemia (AML) per the 2016 WHO Classification, with the specific definitions as follows:\n\nConfirmed AML with bone marrow blasts ≥5% at screening, and meeting any one of the following criteria:\n\n* Relapsed disease: Relapse after achieving complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following standard induction chemotherapy;\n* Refractory disease: a) Failure to achieve CR\u002FCRi after 2 cycles of induction chemotherapy; b) Relapse within 12 months of first remission with no response to subsequent re-treatment; c) Relapse after autologous or allogeneic hematopoietic stem cell transplantation; d) Failure to achieve CR\u002FCRi after at least two lines of salvage therapy.\n\n  * 4\\. Confirmed positive expression of CD33 or CD70 via flow cytometry and\u002For immunohistochemistry.\n  * 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n  * 6\\. Estimated survival of more than 12 weeks.\n  * 7\\. Toxicities resulting from prior therapies must be stabilized and recovered to Grade ≤1 (alopecia and other toxicities with no significant clinical impact are excluded).\n  * 8\\. Adequate hepatic, renal, pulmonary and cardiac function, meeting the following specific criteria:\n  * o Estimated creatinine clearance (calculated via the Cockcroft-Gault formula) ≥60 mL\u002Fmin;\n  * o Serum alanine aminotransferase\u002Faspartate aminotransferase (ALT\u002FAST) ≤2.5 times the upper limit of normal (ULN);\n  * o Total bilirubin ≤1.5 mg\u002FdL (participants with Gilbert's syndrome excluded from this criterion);\n  * o Cardiac ejection fraction ≥50%, no evidence of pleural effusion on echocardiogram (ECHO), and no clinically significant abnormalities on electrocardiogram (ECG);\n  * o Absence of clinically significant pleural effusion;\n  * o Baseline oxygen saturation \\>92% while breathing room air.\n  * 9\\. Females of childbearing potential: Serum or urine pregnancy test negative at screening (subjects with surgical sterilization or menopause for ≥2 years are not considered of childbearing potential). Must agree to use highly effective and reliable contraception for 1 year after receiving study treatment, and refrain from oocyte donation.\n  * 10\\. Male participants: If sexually active with females of childbearing potential, must agree to use highly effective and reliable contraception for 1 year after receiving study treatment, and refrain from sperm donation.\n\nExclusion Criteria:\n\n* 1\\. Prior history of central nervous system (CNS) leukemia; or intracranial magnetic resonance imaging (MRI)\u002FPET-CT at screening suggestive of CNS leukemia; or malignant cells identified in cerebrospinal fluid (CSF).\n* 2\\. Other untreated malignant neoplasms diagnosed within the past 5 years or concurrent malignancies (Exceptions: adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, urothelial carcinoma ≤T1; participants with prostate cancer under active surveillance are eligible).\n* 3\\. Prior receipt of CD33- or CD70-targeted cellular therapies including CAR-T, NK or iNKT cells (Excluding subjects previously treated with GT737 who qualify for re-treatment).\n* 4\\. Systemic corticosteroids administered within 7 days prior to cell infusion (Exceptions: inhaled corticosteroids and subjects with prior allogeneic transplantation history).\n* 5\\. History of hypersensitivity to any component of investigational products to be used in this study, including but not limited to GT737 cell infusion product, cyclophosphamide and fludarabine.\n* 6\\. Uncontrolled suspected or confirmed fungal, bacterial, viral or other infections, or infections requiring intravenous (IV) antimicrobial therapy (Excluding prophylactic antimicrobial treatment).\n\n  7\\. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, cytomegalovirus IgM (CMV-IgM), Epstein-Barr virus IgM (EBV-IgM).\n* 8\\. Active hepatitis B (positive HBV-DNA) and\u002For active hepatitis C (positive HCV RNA).\n\nParticipants positive for HBsAg\u002FHBcAb must undergo HBV-DNA testing; those with negative HBV-DNA may be enrolled. Post-enrollment, prophylactic antiviral therapy shall be administered if clinically indicated per investigator assessment.\n\nSubjects with negative HCV antibody are eligible for enrollment. Participants with positive HCV antibody must receive HCV RNA testing and may be enrolled only if HCV RNA is negative.\n\n* 9\\. Presence of any indwelling line or drainage tube (Exceptions: dedicated central venous access catheters such as Port-a-Cath and Hickman catheter).\n* 10\\. Current or prior central nervous system disorders including seizures, cerebral ischemic\u002Fhemorrhagic events, dementia, cerebellar disease, or any autoimmune disease involving the CNS.\n* 11\\. Cardiac involvement secondary to acute myeloid leukemia.\n* 12\\. Occurrence of any of the following within 6 months prior to signing the informed consent form:\n\n  * Uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy;\n  * Stroke (Excluding lacunar infarction), coronary or peripheral artery bypass graft surgery;\n  * Clinically significant arrhythmias (e.g., ventricular arrhythmia), markedly prolonged QT interval (corrected QTc ≥500 ms by Bazett's formula, as judged by the investigator);\n  * Uncontrolled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg), uncontrolled diabetes mellitus;\n  * Pulmonary embolism, diffuse pulmonary infiltrates, impaired pulmonary function;\n  * Other medical conditions deemed unsuitable for study participation by the investigator.\n* 13\\. Anticipated or potential need for emergency treatment within 6 weeks due to ongoing or imminent oncologic emergencies (e.g., tumor mass effect, tumor lysis syndrome).\n* 14\\. Primary immunodeficiency disorders.\n* 15\\. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment requiring systemic anticoagulation therapy.\n* 16\\. Any medical condition that may interfere with the assessment of safety or efficacy of the study treatment.\n* 17\\. Live attenuated vaccines or mRNA vaccines administered within 8 weeks prior to lymphodepleting conditioning; inactivated vaccines administered within 4 weeks prior to lymphodepleting conditioning.\n* 18\\. Females of childbearing potential who are pregnant or breastfeeding (Subjects with surgical sterilization or menopause for ≥2 years are not regarded as of childbearing potential).\n* 19\\. Male or female participants unwilling to use contraceptive measures from the time of informed consent through 6 months after completion of study treatment.\n* 20\\. Participants judged by the investigator to be unlikely to complete all study visits and procedures (including follow-up) or unable to comply with study participation requirements.\n* 21\\. History of autoimmune disease within the past 2 years causing end-organ damage or requiring systemic immunosuppressive agents\u002Fsystemic disease-modifying therapy (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.).","ALL","18 Years","75 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","This is a single-arm, open-label, dose-escalation, prospective exploratory clinical study intended to evaluate the safety, efficacy and cellular pharmacokinetics of GT737 cells in adult patients with relapsed\u002Frefractory acute myeloid leukemia (AML).",[26],"Relapsed\u002FRefractory Acute Myeloid Leukemia (AML)","NOT_YET_RECRUITING","2026-06-29",{"date":30,"type":31},"2026-06-30","ACTUAL",{"date":33,"type":20},"2026-07-01",{"date":35,"type":20},"2030-06",{"name":37,"class":38},"Grit Biotechnology","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":39},"100618553","early-phase-1-a-clinical-study-to-evaluate-the-safety-and-efficacy-of-gt801-injection-in-the-treatment-of-moderate-to-severe-refractory-autoimmune-diseases-100618553","NCT07333118","A Clinical Study to Evaluate the Safety and Efficacy of GT801 Injection in the Treatment of Moderate-to-Severe Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* 1\\. The participant or their legal representative voluntarily signs a written informed consent form and is willing and able to comply with the study procedures.\n* 2\\. Aged 18 to 65 years old (inclusive) at the time of signing the informed consent, regardless of gender.\n* 3\\. Participants with Systemic Lupus Erythematosus (SLE) must meet the following criteria:\n* a) Fulfill the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for SLE.\n* b) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score ≥ 6, with at least one British Isles Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestation) or two Grade B (moderate manifestation) organ scores, or both; or SLEDAI-2000 score ≥ 8.\n* c) Meet the definition of refractory or relapsing disease: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 4\\. Participants with Idiopathic Inflammatory Myopathy (IIM) must meet the following criteria:\n* a) Fulfill the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including Dermatomyositis \\[DM\\], Polymyositis \\[PM\\], Antisynthetase Syndrome \\[ASS\\], and Necrotizing Myopathy \\[NM\\]).\n* b) Positive for myositis-specific antibodies or myositis-associated antibodies.\n* c) Must have moderate to severe IIM at screening, defined as Manual Muscle Testing-8 (MMT-8) score ≥ 142, or MMT-8 score \\\u003C 142 plus meeting 2 of the following criteria:\n* 1\\) Physician Global Assessment (PGA) (Visual Analog Scale \\[VAS\\]) ≥ 2 cm (on a 10-cm VAS).\n* 2\\) Patient Global Assessment (PtGA) (VAS) ≥ 2 cm (on a 10-cm VAS).\n* 3\\) Health Assessment Questionnaire (HAQ) score \\> 0.25.\n* 4\\) Elevation of one or more muscle enzymes (creatine kinase \\[CK\\], lactate dehydrogenase \\[LDH\\], aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\]) ≥ 1.5 × Upper Limit of Normal (ULN).\n* d) Meet the definition of refractory\u002Frelapsing or progressive disease:\n* 1\\) Refractory\u002Frelapsing: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 2\\) Progressive: Development of worsening myositis or rapidly progressive interstitial lung disease.\n* 5\\. Participants with Systemic Sclerosis (SSc) must meet the following criteria:\n* a). Fulfill the 2013 American College of Rheumatology (ACR) classification criteria for SSc.\n* b). Positive for SSc-related autoantibodies.\n* c). Meet the definition of refractory\u002Frelapsing or progressive disease:\n* 1\\) Refractory\u002Frelapsing: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 2\\) Refractory\u002Frelapsing: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 6\\. Participants with ANCA-Associated Vasculitis (AAV) must meet the following criteria:\n* a). Fulfill the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n* b). Positive for ANCA-related antibodies (myeloperoxidase-ANCA \\[MPO-ANCA\\] or proteinase 3-ANCA \\[PR3-ANCA\\]).\n* c). Birmingham Vasculitis Activity Score (BVAS) ≥ 15 points (total score: 63 points), indicating active vasculitis.\n* d). Meet the definition of refractory\u002Frelapsing disease: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 7\\. Participants with Sjogren's Syndrome must meet the following criteria:\n* a). Fulfill the 2002 American-European Consensus Group (AECG) criteria for primary Sjogren's Syndrome or the 2016 ACR\u002FEULAR classification criteria.\n* b). EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score ≥ 6.\n* c). Positive for anti-SSA\u002FRo antibodies.\n* d). Meet the definition of refractory\u002Frelapsing disease: No response to conventional treatment for more than 6 months, or disease reactivation after achieving remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide plus at least one of the following immunomodulatory agents: antimalarials, azathioprine, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents including rituximab, belimumab, and tabalumab.\n* 8\\. Laboratory test results at screening must meet the following criteria (excluding indicators related to the study disease):\n* a). Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL.\n* b). Hemoglobin ≥ 80 g\u002FL; Platelet count ≥ 50 × 10⁹\u002FL.\n* c). Alanine Aminotransferase (ALT) ≤ 3 × ULN; Aspartate Aminotransferase (AST) ≤ 3 × ULN (unless elevations of ALT and\u002For AST are assessed by the investigator to be related to Polymyositis \\[PM\\] or Dermatomyositis \\[DM\\]); Total Bilirubin (TBIL) \\\u003C 2 × ULN (for participants with Gilbert's syndrome, Direct Bilirubin \\[DBIL\\] ≤ 1.5 × ULN).\n* d). Creatinine clearance rate ≥ 30 mL\u002Fmin.\n* e). Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN; Prothrombin Time (PT) ≤ 1.5 × ULN.\n* f). Left Ventricular Ejection Fraction (LVEF) ≥ 50% confirmed by echocardiography, with no clinically significant electrocardiogram (ECG) abnormalities detected.\n* g). Baseline oxygen saturation \\> 92% measured on room air.\n* 9\\. Women of childbearing potential must:\n* a). Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening, confirmed by the investigator.\n* b). Agree to avoid breastfeeding during study participation until at least 1 year after GT801 injection or until GT801 cells are no longer detectable by two consecutive flow cytometry tests, whichever is later.\n* c). Male participants with sexual partners and female participants of childbearing potential must agree to use highly effective contraceptive methods (e.g., oral contraceptives, intrauterine devices, or condoms) starting from screening until at least 1 year after GT801 injection or until GT801 cells are no longer detectable by two consecutive flow cytometry tests, whichever is later. Male participants must agree to use condoms during sexual contact with pregnant women or women of childbearing potential for at least 1 year after GT801 injection, even after successful vasectomy.\n\nExclusion Criteria:\n\n* 1\\. Participants with SLE\n* a. Drug-induced systemic lupus erythematosus.\n* b. Participants with lupus crisis; or those with concurrent diseases requiring the use of protocol-prohibited drugs, who are deemed ineligible for enrollment by the investigator.\n* 2\\. Participants with IIM\n* a. Documented inclusion body myositis (IBM), drug-induced polymyositis (PM) or dermatomyositis (DM), malignancy-associated PM or DM, or non-inflammatory myopathies (e.g., muscular dystrophy).\n* b. Uncontrolled extramuscular disease manifestations related to PM or DM:\n* 1\\) ILD: Forced vital capacity (FVC) \\\u003C 55% or requirement for oxygen therapy.\n* 2\\) Severe dysphagia manifestations that, in the investigator's judgment, would increase the participant's risk of participating in the clinical trial.\n* 3\\) Severe cardiac manifestations (e.g., congestive heart failure, cardiac arrhythmia, conduction abnormalities requiring treatment, or myocardial infarction) that, in the investigator's judgment, would increase the participant's risk of participating in the clinical trial.\n* 3\\. Participants with SSc\n* a. Severe SSc-associated pulmonary arterial hypertension (PAH) that is uncontrollable with medical treatment.\n* b. Rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement requiring parenteral nutrition; active gastric antral vascular ectasia.\n* c. Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO₂) \\\u003C 92% (on room air at rest); or requirement for mechanical ventilation support within 1 year prior to signing the informed consent form.\n* 4\\. Participants with ANCA-Associated Vasculitis (AAV)\n* a. Presence of rapidly progressive glomerulonephritis, acute mononeuritis multiplex, or central nervous system (CNS) involvement unrelated to AAV at screening.\n* b. Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive hemorrhage, cerebral vasculitis, cardiac vasculitis, etc.).\n* c. Secondary vasculitis (e.g., systemic lupus erythematosus, Henoch-Schönlein purpura, drug-induced, malignancy-related, infection-related, primary immunodeficiency, etc.).\n* 5\\. Participants with Sjögren's Syndrome (SS)\n* a. Presence of poorly controlled severe systemic primary Sjögren's disease (pSjD) manifestations at baseline that, in the investigator's assessment, would place the participant at excessive risk, including pSjD-associated cytopenia of Grade ≥ 2 per the Common Terminology Criteria for Adverse Events (CTCAE).\n* b. Secondary Sjögren's syndrome with a primary diagnosis of other confirmed autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and inflammatory bowel disease).\n* c. Regular use of medications known to cause xerostomia\u002Fkeratoconjunctivitis sicca (a common major side effect).\n* d. Concomitant diseases that may interfere with the efficacy assessment of primary Sjögren's syndrome, e.g., inflammatory bowel disease, gout, sarcoidosis, amyloidosis, graft-versus-host disease, IgG4-related disease, etc.\n\nAll Participants:\n\n* 6\\. History of severe hypersensitivity reactions or allergies.\n* 7\\. Detection of pre-existing anti-polyethylene glycol (anti-PEG) antibodies in the body prior to GT801 infusion.\n* 8\\. Contraindications to or hypersensitivity reactions to any component of the investigational product.\n* 9\\. History of the following cardiac diseases:\n* a. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n* b. Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening.\n* c. History of clinically significant ventricular arrhythmia or unexplained syncope not caused by vasovagal response or dehydration; or corrected QT interval (QTc) \\> 480 ms at screening; history of severe non-ischemic cardiomyopathy.\n* 10\\. History of any active malignancy or malignant tumor within 5 years prior to screening, except for the following conditions: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumors, non-ulcerative primary melanoma with depth \\\u003C 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast that has undergone potentially curative treatment.\n* 11\\. Any other known autoimmune diseases besides the study disease.\n* 12\\. Long-term use of anticoagulant drugs that affect coagulation function.\n* 13\\. Clinically significant bleeding symptoms or confirmed bleeding tendency within 6 months prior to screening (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.); hereditary or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, hypersplenism, etc.); arterial or venous thrombotic events within 6 months prior to screening (e.g., cerebrovascular diseases including cerebral hemorrhage and cerebral infarction, deep vein thrombosis, and\u002For pulmonary embolism).\n* 14\\. Presence of severe underlying medical conditions at screening, such as:\n* a. Evidence of uncontrolled viral, bacterial, fungal, or other infections requiring systemic intravenous therapy.\n* b. Clear clinical evidence of dementia or altered mental status.\n* c. History of any other central nervous system diseases or neurodegenerative disorders (e.g., epilepsy, convulsions, paralysis, aphasia, stroke, severe traumatic brain injury, dementia, Parkinson's disease, psychosis).\n* 15\\. Positive results for any of the following tests:\n* a. Human Immunodeficiency Virus (HIV) antibody positive.\n* b. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV)-DNA levels above the lower limit of quantification of the assay.\n* c. Hepatitis C virus (HCV) antibody positive with HCV RNA levels above the lower limit of quantification of the assay.\n* d. Syphilis antibody positive (excluding false-positive results caused by underlying diseases).\n* 16\\. Positive results for cytomegalovirus (CMV) DNA or Epstein-Barr virus (EBV) DNA testing.\n* 17\\. Active tuberculosis or latent tuberculosis that has not received appropriate treatment prior to screening.\n* 18\\. Receipt of other investigational drugs within 4 weeks prior to signing the informed consent form (ICF); or the interval between the ICF signing date and the last dose of the previous clinical trial participation is still within 5 half-lives of the drug, whichever is longer.\n* 19\\. Receipt of plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to investigational product administration.\n* 20\\. Receipt of B-cell-targeted drug therapy within 1 week prior to investigational product administration, including but not limited to rituximab, belimumab, tabalumab, etc.\n* 21\\. Receipt of biologic therapy such as anti-TNF-α antibodies within 12 weeks prior to investigational product administration.\n* 22\\. Use of tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to investigational product administration.\n* 23\\. Receipt of neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod, etc.) within 3 weeks prior to investigational product administration.\n* 24\\. Receipt of complement inhibition therapy (e.g., eculizumab, etc.) within 3 weeks prior to investigational product administration.\n* 25\\. Vaccination with live attenuated vaccines or mRNA vaccines within 8 weeks prior to enrollment; or inactivated vaccines within 4 weeks prior to enrollment.\n* 26\\. Major surgery within 8 weeks prior to screening, or planned surgery during the study period.\n* 27\\. History of organ transplantation.\n* 28\\. Prior receipt of chimeric antigen receptor T-cell (CAR-T) therapy targeting any antigen.\n* 29\\. Presence of any conditions that, in the investigator's judgment, would prevent the participant from completing the entire trial, confound trial results, or make trial participation not in the participant's best interest.","65 Years",{"count":48,"type":20},22,[23],"This is a single-arm, open-label, dose-escalation and dose-expansion clinical trial designed to evaluate the safety, efficacy, and cellular metabolism kinetics of GT801 in the treatment of moderate-to-severe refractory autoimmune diseases. Interim analysis will be conducted when 5 patients complete primary endpoint measurement.",[52],"Moderate to Severe Refractory Autoimmune Disease","RECRUITING","2026-05-22",{"date":56,"type":31},"2026-05-27",{"date":58,"type":31},"2025-11-07",{"date":60,"type":20},"2028-03-31",{"name":37,"class":38},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100608727","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt801-injection-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-and-autoimmune-hemolytic-anemia-100608727","NCT07205315","A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed\u002FRefractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female;\n* Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;\n* Disease progression or recurrence after at least second-line drug treatment;\n* CD19 positivity confirmed by flow cytometry and\u002For histopathology (excluding autoimmune hemolytic anemia);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);\n* Expected survival period \\> 12 weeks\n* For participants with hematological malignancies, the following requirements must be met:\n\nFor any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.\n\nFor any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.\n\n• For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg\u002Fm²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.\n\nExclusion Criteria:\n\n* Participants with a history of central nervous system leukemia\u002Flymphoma, or those with central nervous system (CNS) leukemia\u002Flymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;\n* Subjects with myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases;\n* Subjects with a history of or current comorbidities that cause coagulation disorders and high bleeding risk, such as disseminated intravascular coagulation (DIC), decompensated cirrhosis, esophagogastric varices, etc.;\n* Subjects who experienced severe bleeding (defined as bleeding uncontrollable by medication or local therapy) within 4 weeks prior to screening, or have life-threatening bleeding (associated with thrombocytopenia) currently, or are expected to require emergency treatment within one week after enrollment;\n* Subjects with secondary AIHA induced by drugs or infections;\n* Subjects with hereditary hemolytic diseases or other acquired hemolytic diseases.\n* Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;\n* If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;\n* Administration of hormonal drugs in any form within 14 days prior to infusion (except for AIHA participants requiring such drugs for hemolysis control and those receiving them for preconditioning).\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and\u002For core antibody but have HBV-DNA test results within the normal range can be included; participants who are positive for hepatitis C virus (HCV) antibody but with HCV RNA test results within the normal range are eligible for inclusion.\n* Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;\n* Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary\u002Fperipheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;\n* Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year).\n* A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression\u002Fsystemic disease-modifying agents within the past 2 years.",{"count":69,"type":20},28,[23],"The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed\u002Frefractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.",[73,74,75,76],"B-cell Acute Lymphoblastic Leukemia (B-ALL)","Chronic Lymphocytic Leukemia (CLL)","B-cell Non-Hodgkin's Lymphoma (B-NHL)","Autoimmune Hemolytic Anemia (AIHA)",{"date":56,"type":31},{"date":79,"type":31},"2025-09-26",{"date":81,"type":20},"2028-08-31",{"name":37,"class":38},2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":39},"100530706","clinical-study-of-gt201-in-combination-with-pd-1-inhibitor-for-advanced-head-and-neck-tumors-100530706","NCT06190275","Clinical Study of GT201 in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors","A Single-Arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Infusion (GT201) in Combination With PD-1 Inhibitor for Advanced Head and Neck Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily join the study, signed informed consent form,, willing and able to comply with the study protocol;\n* 2\\. Age 18 to 70 years old;\n* 3\\. Diagnosis with recurrent or metastatic head and neck malignant tumors and received≤2 lines of systemic therapy;\n* 4\\. Have at least one measurable lesion that is untreated with radiotherapy or other local therapies, is accessible for tumor tissue collection (assessed by the investigator), and can provide a tissue block with a mass ≥1.0 g (approximately 1.5 cm in diameter) for autologous tumor-infiltrating lymphocyte (TIL) preparation. The tissue collection procedure should be minimally invasive whenever possible.\n* 5\\. After tumor sampling, have at least one measurable lesion as defined by RECIST v1.1.\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 7\\. Expected survival time of ≥ 12 weeks;\n* 8\\. Adequate function of major organs, with the following requirements (administration of any blood components or cell growth factors is not allowed within 14 days prior to surgery):\n\n  1. Hematology:\n\n     * Absolute Neutrophil Count (ANC) ≥ 1.0×10⁹\u002FL;\n     * Lymphocyte Count (LC) ≥ 0.5×10⁹\u002FL;\n     * Platelet Count (PLT) ≥ 80×10⁹\u002FL;\n     * Hemoglobin (Hb) ≥ 90 g\u002FL.\n  2. Liver function:\n\n     * Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), and Alkaline Phosphatase (ALP) ≤ 2.5×Upper Limit of Normal (ULN);\n     * Total Bilirubin (TBIL) ≤ 1.5×ULN.\n\n     The following exceptions apply:\n     * For confirmed liver metastases: AST and\u002For ALT ≤ 5×ULN;\n     * For confirmed liver or bone metastases: ALP ≤ 5×ULN;\n     * For confirmed Gilbert's syndrome: TBIL ≤ 3.0 mg\u002FdL.\n  3. Renal function:\n\n     • Creatinine Clearance (CrCL) ≥ 45 mL\u002Fmin (calculated by the Cockcroft-Gault formula), or serum creatinine within the normal range.\n  4. Coagulation function:\n\n     * Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN;\n     * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5×ULN simultaneously.\n  5. Adequate cardiac function.\n  6. Adequate pulmonary function.\n* 9\\. For women of childbearing potential who have not undergone surgical sterilization:\n\n  * Agree to use at least one medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 1 year after the end of study treatment;\n  * Serum human chorionic gonadotropin (HCG) test result must be negative at screening.\n* 10\\. Adverse reactions caused by prior therapies have resolved to ≤ Grade 1 per CTCAE v5.0 before tumor sampling.\n* 11\\. For subjects enrolled due to insufficient efficacy or intolerability of prior therapies, medical records documenting disease status after prior treatment or imaging records of lesion assessment must be available before tumor sampling.\n\nExclusion Criteria:\n\n* 1\\. Uncontrolled local or systemic infections of the oral cavity, head, or neck; any active autoimmune disease, history of autoimmune disease, or disease requiring systemic corticosteroid therapy or immunosuppressive drugs (prednisone equivalent dose \\> 10 mg\u002Fday).\n* 2\\. Subjects with uncontrollable tumor-related pain assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at study entry; symptomatic lesions eligible for palliative radiotherapy should have completed treatment prior to study entry.\n* 3\\. Bleeding events occurring within 3 months prior to screening, including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or subjects assessed by the investigator as having a high risk of major bleeding, including but not limited to tumors encasing or invading major blood vessels \\[i.e., carotid artery, jugular vein, bronchial artery\\] and\u002For exhibiting other high-risk features (e.g., fistula, significant cavitary lesions, history of bleeding \\[≤ 60 days from signing the ICF\\]).\n* 4\\. Arterial\u002Fvenous thrombotic events occurring within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism.\n* 5\\. A history of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory diseases that severely impair pulmonary function.\n* 6\\. A history of clinically significant cardiovascular disease, including but not limited to: (1) congestive heart failure (NYHA class \\> 2); (2) unstable angina pectoris; (3) myocardial infarction within the past 3 months; (4) any supraventricular or ventricular arrhythmia requiring treatment or intervention.\n* 7\\. Subjects with ≥ 3 untreated central nervous system (CNS) metastases at screening. Exclusion exception: Subjects with ≤ 3 CNS metastases, with the largest lesion \\\u003C 1 cm in diameter, no peritumoral edema on brain imaging (MRI or CT), and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment may be enrolled.\n* 8\\. Ineligible for enrollment if spinal cord compression has not been relieved by surgery and\u002For radiotherapy. Exclusion exception: Subjects with active CNS metastases are excluded, except for those with stable brain metastases who have not required medical treatment for 3 months and are not dependent on corticosteroids.\n* 9\\. A history of malignant tumors other than the target indication within 5 years prior to screening (excluding adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, and breast ductal carcinoma in situ after radical resection), unless the investigator determines that the benefits to the subject outweigh the risks.\n* 10\\. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion, etc., that cannot be controlled by medication, or contraindications to interleukin-2 (IL-2) use.\n* 11\\. A history of infectious diseases within 1 year prior to screening, such as HIV, syphilis, active viral hepatitis, active pulmonary tuberculosis, active EBV and\u002For CMV infection; or a history of active pulmonary tuberculosis infection for more than 1 year without standard treatment. Active hepatitis B or hepatitis C is excluded. Enrollment exceptions:\n\n  * Subjects positive for HBsAg or HBcAb may participate if HBV DNA test results are below the lower limit of normal (LLN) at the testing site;\n  * Subjects positive for HCV antibody may participate if HCV RNA test results are below the LLN at the testing site.\n\nCarriers enrolled in the study should receive antiviral therapy as appropriate and undergo regular nucleic acid copy number quantitative testing during the study period.\n\n* 12\\. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to surgical tumor sampling.\n* 13\\. Previous allogeneic bone marrow transplantation or solid organ transplantation.\n* 14\\. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, excluding the following situations:\n\n  * Bridging therapy;\n  * If prior treatment included nitrosourea or mitomycin chemotherapy, the interval between the end of chemotherapy and the expected start of lymphodepletion conditioning must be at least 6 weeks for enrollment;\n  * If prior treatment included small-molecule targeted therapy, the interval between the end of treatment and the expected start of lymphodepletion conditioning must be at least 5 half-lives of the drug for enrollment.\n* 15\\. Previous receipt of genetically modified or edited cell therapy products (excluding autologous immune cell therapy products without genetic modification or editing if more than 1 year has passed since cell infusion).\n* 16\\. A history of hypersensitivity reactions to any component of the drugs intended for use in the study, including but not limited to autologous tumor-infiltrating lymphocytes (TILs), cyclophosphamide, fludarabine, interleukin-2 (IL-2), dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, and antibiotics (β-lactam antibiotics, gentamicin).\n* 17\\. Known history of mental illness, alcoholism, drug addiction, or substance abuse.\n* 18\\. Previous grade 3 or higher adverse reactions to immunotherapy that failed to resolve to CTCAE grade 1 or below within 28 days; or any other disease or condition that could reasonably be suspected to contraindicate the use of investigational products, interfere with the interpretation of study results, or place the subject at high risk of treatment complications (including any other disease, metabolic disorder, abnormal physical examination finding, or abnormal laboratory test result).\n* 19\\. Pregnant or lactating women; or women planning to become pregnant, lactate, or conceive within 1 year after cell infusion.\n* 20\\. Receipt of other investigational products within 4 weeks prior to lymphodepletion conditioning, or planned participation in other investigational product studies during the study period.\n* 21\\. Other conditions deemed unsuitable for enrollment by the investigator.","70 Years",{"count":93,"type":20},32,[95],"NA","This study is a single-arm early exploratory clinical study. designed to evaluate the safety and tolerability of GT201 in combination with a PD-1 inhibitor for the treatment of advanced head and neck tumor subjects with safety and tolerability, as well as pharmacokinetic characterization and efficacy The study consists of two phases.\n\nThe study consists of two phases, a dose-escalation phase and a dose-expansion phase.",[98],"HNSCC","2026-04-23",{"date":101,"type":31},"2026-04-24",{"date":103,"type":31},"2024-05-12",{"date":105,"type":20},"2027-04-30",{"name":37,"class":38},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":39},"100622890","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt719-universal-cell-injection-in-the-treatment-of-immune-mediated-kidney-diseases-100622890","NCT07389499","A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases","Inclusion Criteria:\n\n* 1\\. The participant or their legal representative voluntarily signs a written informed consent form, and is willing and able to comply with the procedures of this study.\n* 2\\. Aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender.\n* 3\\. Positive expression of CD19 on B cells in peripheral blood is confirmed by flow cytometry.\n* 4\\. Participants with IgA nephropathy (IgAN) at high risk of progression:\n\n  ① A definite pathological diagnosis of IgAN confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n  * Meet at least one of the following requirements:\n\n    1. Prior treatment with glucocorticoids, budesonide enteric-coated capsules, immunosuppressants (including mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, Tripterygium wilfordii, leflunomide, azathioprine), or biological agents (including but not limited to anti-CD20 monoclonal antibodies, telitacicept, daratumumab) for a cumulative duration of at least 3 months, with persistent 24-hour urinary protein ≥ 0.75 g or UPCR ≥ 0.75 g\u002Fg.\n    2. The predicted probability of a 50% decline in eGFR or end-stage renal disease (ESRD) within 5 years calculated by the international IgAN prediction tool is ≥ 20%.\n    3. A ≥ 20% decline in eGFR within 3 months.\n    4. Renal biopsy performed within 6 months indicating Oxford classification C2 lesion.\n    5. Patients who are intolerant to conventional treatment and for whom the investigator determines that the benefits outweigh the risks, with adequate informed consent obtained, may be considered for inclusion.\n* 5\\. Participants with ANCA-associated vasculitis (AAV)\u002FANCA-associated glomerulonephritis (AAGN) must meet the following criteria:\n\n  ① Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis.\n\n  ② Positive anti-myeloperoxidase (MPO-ANCA) antibody or anti-proteinase 3 (PR3-ANCA) antibody detected during screening or in previous tests.\n\n  ③ AAGN: Availability of a renal biopsy pathological report within 2 years; if eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m², a renal biopsy pathological report obtained during the screening period is required. Presence of active lesions according to the 2010 Berden classification criteria for AAGN.\n\n  ④ Renal-uninvolved AAV: Birmingham Vasculitis Activity Score (BVAS) version 3.0 ≥ 3 points, indicating active vasculitis.\n\n  ⑤ Failure of standard of care (SOC), defined as any of the following:\n\n  a) Failure to achieve remission after at least 3 months of treatment with glucocorticoids combined with cyclophosphamide or rituximab.\n\n  b) Disease relapse after achieving remission. c) Persistent disease activity despite receiving SOC for at least 6 months, including glucocorticoids, cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as other biological agents (including but not limited to mepolizumab) or avacopan.\n* 6\\. Participants with membranous nephropathy (MN) must meet the following criteria:\n\n  * Definite pathological diagnosis of primary (idiopathic) MN confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n\n    ② Elevated serum anti-PLA2R antibody titer detected during screening or in previous tests, or positive PLA2R antigen staining in renal tissue.\n\n    ③ eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².\n\n    ④ Meeting the criteria for high-risk or relapsed\u002Frefractory MN: c) High-risk patients, defined as meeting any of the following: Normal eGFR, urinary protein \\> 3.5 g\u002F24h, \\\u003C 50% reduction in urinary protein after 6 months of ACEI\u002FARB treatment, and serum albumin \\\u003C 25 g\u002FL or anti-PLA2R antibody \\> 50 RU\u002FmL.\n\neGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m² and\u002For urinary protein \\> 8 g\u002F24h for more than 6 months.\n\nd) Relapsed\u002Frefractory patients: Relapsed patients: Defined as achieving complete or partial remission with previous SOC treatment, followed by recurrence of urinary protein ≥ 3.5 g\u002F24h.\n\nRefractory patients: Defined as refractory to previous SOC treatment (persistent urinary protein ≥ 3.5 g\u002F24h with \\\u003C 50% reduction compared to baseline).\n\n* 7\\. Participants with refractory podocytopathy:\n\n  ① Pathological diagnosis of minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) confirmed by renal biopsy (renal biopsy must be performed within 2 years prior to screening or during the screening period).\n\n  ② Meet at least one of the following requirements:\n  1. Previous diagnosis of steroid-resistant nephrotic syndrome (SRNS): 24-hour urinary protein \\> 3 g or UPCR ≥ 3.5 g\u002Fg, serum albumin \\\u003C 30 g\u002FL, failure to achieve complete remission after 4 weeks of standard-dose glucocorticoid treatment.\n  2. Previous diagnosis of steroid-dependent nephrotic syndrome (SDNS): Remission achievable with glucocorticoid treatment, but relapse within 2 weeks of glucocorticoid tapering or discontinuation, or two consecutive relapses during glucocorticoid tapering.\n  3. Previous diagnosis of frequently relapsing nephrotic syndrome (FRNS): ≥ 3 relapses within 1 year or ≥ 2 relapses within 6 months after achieving complete remission with glucocorticoid treatment.\n  4. Previous treatment with one immunosuppressant (including cyclosporine A, tacrolimus, mycophenolate mofetil, cyclophosphamide) or biological agent (including but not limited to anti-CD20 monoclonal antibodies, telitacicept, daratumumab) for ≥ 6 months without achieving remission or with intolerance.\n  5. Failure to achieve remission within 6 months of adequate treatment with one immunosuppressant or biological agent, but the investigator judges that the benefits outweigh the risks and the patient has provided full informed consent, the patient may be considered for inclusion.\n* 8\\. Participants with proliferative glomerulonephritis with monoclonal immunoglobulin deposition (PGNMID):\n\n  * Definite pathological diagnosis of PGNMID confirmed by renal biopsy (renal biopsy must be performed within 3 years prior to screening or during the screening period).\n\n    * Meet at least one of the following requirements:\n\nPersistent 24-hour urinary protein ≥ 1 g or UPCR ≥ 1 g\u002Fg despite treatment with angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 4 weeks.\n\neGFR ≥ 30 mL\u002Fmin\u002F1.73 m² with progressive decline (≥ 20% decrease in eGFR) within the recent 6-12 months.\n\nDevelopment of nephrotic syndrome or nephrotic-range proteinuria (24-hour urinary protein ≥ 3 g or UPCR ≥ 3 g\u002Fg) without stable remission with short-term glucocorticoid treatment.\n\n③ Exclusion of hematological malignancies (leukemia, lymphoma, multiple myeloma, systemic light chain amyloidosis) by bone marrow aspiration and biopsy (bone marrow aspiration must be performed within 6 months prior to screening or during the screening period).\n\n* 9\\. Screening laboratory test results must meet the following criteria (excluding indicators related to the study disease):\n\n  1. Neutrophil count ≥ 1.5 × 10⁹\u002FL;\n  2. Hemoglobin ≥ 80 g\u002FL; Platelet count ≥ 50 × 10⁹\u002FL;\n  3. Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin (TBIL) \\\u003C 2 × ULN (for participants with Gilbert syndrome, direct bilirubin (DBIL) ≤ 1.5 × ULN);\n  4. Creatinine clearance rate ≥ 30 mL\u002Fmin; (except for anti-GBM glomerulonephritis, AAV\u002FANCA-associated glomerulonephritis);\n  5. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN;\n  6. Left ventricular ejection fraction (LVEF) ≥ 50% diagnosed by echocardiography.\n  7. Pulmonary function: Defined as dyspnea ≤ CTCAE Grade 1 and oxygen saturation (SpO₂) ≥ 92% at rest while breathing room air (measured by pulse oximetry).\n* 10\\. Female participants of childbearing potential must:\n\n  a. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result at screening, confirmed by the investigator; b. Agree to avoid breastfeeding during study participation until at least 1 year after GT719 cell infusion or until GT719 cells are no longer detected by two consecutive flow cytometry tests, whichever is later.\n* 11\\. Male participants with sexual partners and female participants of childbearing potential must agree to use highly effective contraceptive methods (e.g., contraceptive pills, intrauterine devices, or condoms) starting from screening until at least 1 year after GT719 cell infusion or until GT719 cells are no longer detected by two consecutive flow cytometry tests, whichever is later. Male participants must agree to use condoms during sexual contact with pregnant women or women of childbearing potential for at least 1 year after GT719 cell infusion, even after successful vasectomy.\n\nExclusion Criteria:\n\n* 1\\. Participants with IgA nephropathy (IgAN) at high risk of progression:\n\n  a. Secondary IgAN (e.g., associated with active hepatitis B\u002Fhepatitis C infection, HIV, etc.).\n* 2\\. Participants with ANCA-associated vasculitis (AAV)\u002FANCA-associated glomerulonephritis (AAGN):\n\n  1. Drug-induced or secondary AAV\u002FAAGN.\n  2. Alveolar hemorrhage requiring invasive mechanical ventilation support at screening.\n* 3\\. Participants with membranous nephropathy (MN):\n\n  a. Secondary membranous nephropathy.\n* 4\\. Participants with refractory podocytopathy:\n\n  a. Hereditary podocytopathy and secondary focal segmental glomerulosclerosis (FSGS).\n* 5\\. Participants with proliferative glomerulonephritis with monoclonal immunoglobulin deposition (PGNMID):\n\n  1. Monoclonal deposition caused by secondary nephropathy (e.g., those diagnosed with multiple myeloma or severe systemic lymphoplasmacytic disease requiring immediate oncological treatment).\n\nFor all participants:\n\n* 6\\. History of severe hypersensitivity reaction or allergy.\n* 7\\. Contraindication or hypersensitivity to fludarabine, cyclophosphamide, or any component of the investigational product.\n* 8\\. Currently receiving renal replacement therapy or expected to require renal replacement therapy during the study period.\n* 9\\. Rapidly progressive glomerulonephritis unrelated to AAV\u002FAAGN, anti-GBM disease, MN, acute post-streptococcal nephritis (APSN), or IgG4-related kidney disease (IgG4-RKD), defined as a ≥ 50% decrease in eGFR within 3 months of diagnosis.\n* 10\\. History of other uncontrolled severe conditions not directly related to the study disease prior to screening, such as severe hemolytic anemia, severe immune thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, active central nervous system (CNS) symptoms including cerebrovascular accident, aneurysm, epilepsy, convulsion, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n* 11\\. History of the following cardiac diseases or conditions:\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure within 12 months prior to screening;\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 caused by vasovagal response or dehydration, or corrected QT interval (QTc) \\> 480 ms at screening;\n  4. History of severe non-ischemic cardiomyopathy;\n  5. Pulmonary arterial hypertension, including secondary pulmonary arterial hypertension, with WHO functional class \\> 2;\n  6. QTcF \\> 450 msec in males and QTcF \\> 470 msec in females, based on the average QTcF (QT interval corrected by Fridericia's formula) value from a single ECG or three repeated ECGs performed at intervals of more than 3 minutes.\n* 12\\. Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening, which the investigator assesses may affect the participant's ability to receive treatment safely or tolerate treatment.\n* 13\\. Evidence of advanced fibrotic interstitial lung disease on chest CT, with the latest pulmonary function test showing forced vital capacity (FVC) \\\u003C 40% of predicted value or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C 30% of predicted value.\n* 14\\. History of any active malignancy or malignant tumor within 5 years prior to screening. Exceptions include: early-stage tumors treated with radical therapy (carcinoma in situ or Stage I tumor, non-ulcerative primary melanoma with depth \\\u003C 1 mm and no lymph node involvement), cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or ductal carcinoma in situ of the breast that has received potentially curative treatment.\n* 15\\. Clinically significant bleeding symptoms or definite bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulation dysfunction, hypersplenism, etc.); occurrence of arteriovenous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and\u002For pulmonary embolism.\n* 16\\. Presence of severe underlying medical conditions at screening, such as:\n\n  1. Evidence of uncontrolled viral, bacterial, fungal, or other infections requiring systemic intravenous treatment;\n  2. Obvious clinical evidence of dementia or altered mental status;\n  3. History of any other CNS disease or neurodegenerative disease, such as epilepsy, convulsion, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis.\n* 17\\. Positive results for any of the following tests:\n\n  1. Human immunodeficiency virus (HIV) antibody positive;\n  2. Hepatitis B surface antigen (HBsAg) positive; or hepatitis B core antibody (HBcAb) positive with hepatitis B virus (HBV)-DNA level above the lower limit of quantification (LLOQ) of the assay;\n  3. Hepatitis C virus (HCV) antibody positive with HCV RNA level above the LLOQ of the assay;\n  4. Syphilis antibody positive (excluding false-positive results caused by underlying diseases).\n* 18\\. H Positive results for cytomegalovirus (CMV) DNA or Epstein-Barr virus (EBV) DNA test.\n* 19\\. Active tuberculosis prior to screening or latent tuberculosis not receiving appropriate treatment.\n* 20\\. Receipt of other investigational drugs within 4 weeks prior to signing the informed consent form (ICF), or the interval between the ICF signing date and the last dose of the previous investigational drug trial is still within 5 half-lives of the drug, whichever is longer.\n* 21\\. Receipt of plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to lymphodepletion conditioning.\n* 22\\. Receipt of B-cell-targeted drug therapy within 1 week prior to lymphodepletion conditioning, including but not limited to rituximab, obinutuzumab, belimumab, telitacicept, etc.\n* 23\\. Receipt of tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to lymphodepletion conditioning.\n* 24\\. Receipt of neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod, etc.) within 3 weeks prior to lymphodepletion conditioning.\n* 25\\. Receipt of complement inhibition therapy (e.g., eculizumab, etc.) within 3 weeks prior to lymphodepletion conditioning.\n* 26\\. Receipt of live attenuated vaccine within 4 weeks prior to lymphodepletion conditioning.\n* 27\\. Performance of major surgery within 8 weeks prior to screening, or planned surgery during the study period.\n* 28\\. History of organ transplantation.\n* 29\\. Previous receipt of CAR-T product therapy targeting any antigen (except for GT719 treatment).\n* 30\\. Presence of any condition that, in the investigator's judgment, would prevent the participant from completing the entire trial, confound trial results, or make trial participation not in the participant's best interest.\n* 31\\. Presence of donor-specific anti-HLA antibodies against GT719 cells.",{"count":114,"type":20},30,[23],"This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase. In the dose-escalation phase, approximately 9-18 adult participants with immune-mediated kidney diseases are planned to be enrolled and treated with GT719 universal cell injection. The objectives of this phase are to evaluate the safety and tolerability of the product, determine the recommended dose (RD) for subsequent studies, conduct a preliminary assessment of its clinical efficacy, and investigate the pharmacokinetic and pharmacodynamic characteristics. Upon completion of the dose-escalation phase, after evaluation by investigators and collaborators, an appropriate dose will be selected for the dose-expansion phase. An additional 12 participants will be enrolled to fully assess the safety and efficacy of the product.",[118,119,120,121,122],"IgA Nephropathy (IgAN)","Membranous Nephropathy","ANCA-associated Vasculitis (AAV)\u002FANCA-associated Glomerulonephritis (AAGN)","Refractory Podocytopathy","Proliferative Glomerulonephritis With Monoclonal Immunoglobulin Deposits","2026-04-22",{"date":99,"type":31},{"date":126,"type":20},"2026-05-30",{"date":128,"type":20},"2028-06-30",{"name":37,"class":38},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100527200","phase-1-gt201-injection-for-the-treatment-of-advanced-solid-tumors-100527200","NCT06144671","GT201 Injection For The Treatment Of Advanced Solid Tumors","A Single-Arm Phase I\u002FII Clinical Study of Autologous Tumor-Infiltrating Lymphocyte Injection (GT201) for The Treatment Of Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), must have the ability to understand the requirements of the study;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues ≥1.0cm\\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible.\n\nExclusion Criteria:\n\n* 1.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\\>10 mg\u002Fday of prednisone or equivalent hormone);\n* 2\\. Arterial\u002Fvenous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 3\\. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, pericardial effusion or IL-2 contraindications;\n* 4\\. Participate in other clinical trials within 4 weeks prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same;\n* 5\\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 6.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin).",{"count":138,"type":20},18,[140,141],"PHASE1","PHASE2","Expected to complete 7 to 18 evaluable subjects (patients with advanced solid tumors)，3 dose groups.A modified \"3+3\" dose-escalation design is utilized,This includes both accelerated dose escalation and traditional \"3+3\" dose escalation.The first dose group is accelerated titration,The first dose group is an accelerated titration of 1 to 6 evaluable subjects;The second and third dose groups are based on the traditional \"3+3\" dose-escalation principle,The second and third dose groups are based on the traditional \"3+3\" dose-escalation principle, with 3 to 6 evaluable subjects enrolled respectively.",[144],"Solid Tumor, Adult",{"date":146,"type":31},"2026-04-27",{"date":148,"type":31},"2023-09-13",{"date":150,"type":20},"2026-09-13",{"name":37,"class":38},4,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":39},"100612413","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt729-universal-cell-injection-in-the-treatment-of-refractory-or-relapsed-chronic-graft-versus-host-disease-cgvhd-100612413","NCT07253259","A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)","Inclusion Criteria:\n\n* Participants or their legal representatives voluntarily sign a written informed consent form, are willing and able to comply with the procedures of this study.\n* Aged 18 to 65 years old (inclusive) when signing the informed consent, regardless of gender.\n* Participants must meet the following criteria:\n\n  1. The subjects are allogeneic hematopoietic stem cell transplantation (alloHSCT) recipients with active chronic graft-versus-host disease (active cGVHD) requiring systemic immunosuppressive therapy.\n  2. The subjects are patients with refractory or relapsed active cGVHD after receiving at least two lines of systemic treatment.\n* The laboratory test results during the screening period must meet the following criteria (except for indicators related to the study disease):\n\n  1. Neutrophil count ≥ 1.0×10⁹\u002FL;\n  2. Hemoglobin ≥ 80g\u002FL; Platelet count ≥ 30×10⁹\u002FL;\n  3. Alanine transaminase ≤ 3×upper limit of normal (ULN); Aspartate transaminase ≤ 3×ULN; Total bilirubin (TBIL) \\\u003C 2×ULN;\n  4. Creatinine clearance rate ≥ 30 mL\u002Fmin.\n* Women of childbearing age must:\n\nAt the time of screening, as confirmed by the investigator, the result of the serum β-human chorionic gonadotropin (β-hCG) pregnancy test is negative.\n\nExclusion Criteria:\n\n* Evidence of recurrence of underlying malignant tumors or post-transplant lymphoproliferative disorder (PTLD) at the time of screening\n* Having a history of severe hypersensitivity or allergies\n* Suffering from the following heart diseases:\n\n  1. New York Heart Association (NYHA) Class III or IV congestive heart failure;\n  2. A myocardial infarction occurred or coronary artery bypass surgery was performed within 6 months before the screening period.\n* Participants with clinically significant bleeding symptoms or a clear bleeding tendency within the 6 months prior to screening;\n* Participants with severe underlying medical conditions at the time of screening;\n* Participants who have undergone major surgery within 8 weeks prior to screening or are scheduled to undergo surgery during the study period;\n* History of organ transplantation;\n* According to the investigator's judgment, there are circumstances that would prevent the participant from completing the entire trial, confuse the trial results, or make participation in the trial not in the best interest of the participant.",{"count":19,"type":20},[23],"The goal of this clinical study is to evaluate the safety and efficacy of GT729 universal cell injection in the treatment of refractory or relapsed chronic graft-versus-host disease (cGVHD).",[163],"cGVHD","2026-04-13",{"date":166,"type":31},"2026-04-14",{"date":168,"type":31},"2025-12-18",{"date":170,"type":20},"2028-12-31",{"name":37,"class":38},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":39},"100603099","early-phase-1-gt719-injection-for-moderate-to-severe-refractory-autoimmune-disease-100603099","NCT07132112","GT719 Injection for Moderate to Severe Refractory Autoimmune Disease","A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease","Inclusion Criteria:\n\n* 1\\. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.\n* 2\\. Aged 18 to 65 years (inclusive), regardless of gender.\n\nSpecific inclusion criteria:\n\n* 3\\. Participants with systemic lupus erythematosus (SLE)\n\n  1. Meets the classification criteria for SLE in the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR);\n  2. Disease activity score SLEDAI-2000 ≥ 6, with at least one British Islet Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestations) or two Grade B (moderate manifestations) organ scores, or both; Or the disease activity score SLEDAI-2000 ≥ 8;\n* 4\\. Participants with idiopathic inflammatory myopathy （IIM）\n\n  1. Complies with the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM)\n  2. Myositis antibody positive;\n  3. . Meets the definition of recurrence, refractory or progressive;\n* 5\\. Participants with systemic sclerosis\n\n  1. . Meet the 2013 American College of Rheumatology (ACR) SSc criteria;\n  2. . SSc related antibodies are positive;\n  3. . Meets the definition of refractory or progressive recurrence\n\nExclusion Criteria:\n\n* 1\\. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;\n* 2\\. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;\n* 3\\. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;\n* 4\\. Medical history of organ transplantation;\n* 5\\. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);\n* 6\\. According to the investigator's judgment, the situations that hinder participants from participating in the entire trial, confound the trial results, or participate in the trial that are not in the best interests of the participants.",{"count":114,"type":20},[23],"This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.",[183],"Auto Immune Disease",{"date":185,"type":31},"2026-04-16",{"date":187,"type":31},"2025-10-28",{"date":189,"type":20},"2028-08",{"name":37,"class":38},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":39},"100579053","phase-1-ib-t101-injection-for-treatment-of-patients-with-advanced-clear-cell-renal-cell-carcinoma-100579053","NCT06819293","IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma","A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;\n2. Age ≥18 years old;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. Expected survival time of ≥ 3 months;\n\nExclusion Criteria:\n\n1. CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.\n2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects\n3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening\n4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening",{"count":199,"type":20},12,[140],"This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma",[203,204],"Advanced Clear Renal Cell Carcinoma","Adult",{"date":166,"type":31},{"date":207,"type":31},"2024-12-06",{"date":209,"type":20},"2027-12-07",{"name":37,"class":38},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":218,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":39},"100579052","autologous-tumor-infiltrating-lymphocyte-gt307-for-treatment-of-patients-with-advanced-colorectal-cancer-100579052","NCT06819280","Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer","A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Advanced Colorectal Cancer","Inclusion Criteria:\n\n1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;\n2. Age 18 to 70 years old;\n3. Advanced Colorectal Cancer that progresses after first-line chemotherapy；\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n5. Expected survival time of ≥ 12 weeks;\n6. Good function of vital organs;\n7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;\n8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.\n\nExclusion Criteria:\n\n1. Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;\n2. Known mental illness, alcoholism, drug use or substance abuse;\n3. Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;\n4. Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;\n5. The investigators determine that other conditions that make the patient not suitable for enrollment",{"count":138,"type":20},[95],"This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with Advanced Colorectal Cancer,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).",[204],{"date":166,"type":31},{"date":224,"type":31},"2024-06-28",{"date":226,"type":20},"2027-05-27",{"name":37,"class":38},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":39},"100550898","autologous-tumor-infiltrating-lymphocyte-gt307-for-treatment-of-patients-with-solid-tumours-100550898","NCT06453057","Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours","A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours","Inclusion Criteria:\n\n* 1\\. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;\n* 2\\. Age 18 to 70 years old;\n* 3\\. Ovarian cancer that progresses after recurrence or first-line chemotherapy；\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 5\\. Expected survival time of ≥ 12 weeks;\n* 6\\. Good function of vital organs;\n* 7\\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;\n* 8\\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.\n\nExclusion Criteria:\n\n* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;\n* 2.Known mental illness, alcoholism, drug use or substance abuse;\n* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;\n* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;\n* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.",{"count":138,"type":20},[95],"This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).",[204],{"date":166,"type":31},{"date":241,"type":31},"2024-07-04",{"date":243,"type":20},"2027-06-06",{"name":37,"class":38},{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":252,"minAge":16,"maxAge":91,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},"100534665","phase-2-autologous-tumor-infiltrating-lymphocytes-gt101-injection-in-patients-with-recurrent-or-metastatic-cervical-cancer-100534665","NCT06241781","Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","Inclusion Criteria:\n\n* 1\\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC) ,must have the ability to understand the requirements of the study);\n* 2\\. The patient must be 18 to 70 years of age at the time of consent;\n* 3\\. Must have a confirmed diagnosis of malignancy of their receptive histologies or cytology: unresectable recurrent or metastatic cervical carcinomas and previously received≥ 1 prior systemic therapy;\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 5\\. Expected survival time of ≥ 12 weeks;\n* 6\\. Adequate normal organ and marrow function;\n* 7\\. Before tumor resection, the confirmatory imaging of disease progress since last treatment should be documented.\n* 8.Patients must have measurable disease measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (in addition to the resected lesion).\n\nExclusion Criteria:\n\n* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring painkiller must already have had a stable pain management options at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;\n* 2.Patients who have psychiatric disorders, alcohol, drug or substance abuse;\n* 3.Women who are pregnant or breastfeeding, or planning to become pregnant within 1 year after cell infusion;\n* 4.Participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same time;\n* 5.Any other conditions that would make the patient unsuitable candidate for the study at the discretion of the investigator.","FEMALE",{"count":254,"type":20},83,[141],"This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.",[204],{"date":259,"type":31},"2026-04-15",{"date":261,"type":31},"2024-04-02",{"date":263,"type":20},"2027-01-31",{"name":37,"class":38},24,{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":284},"100472322","phase-1-gt101-injection-for-the-treatment-of-metastatic-or-recurrent-solid-tumors-100472322","NCT05430373","GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors","A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors","Inclusion Criteria:\n\n* 1\\. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board\u002FIndependent Ethics Committee (IRB\u002FIEC), must have the ability to understand the requirements of the study;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;\n\nExclusion Criteria:\n\n* 1\\. Patients who have symptomatic and\u002For untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);\n* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\\>10 mg\u002Fday of prednisone or equivalent hormone);\n* 3\\. Arterial\u002Fvenous thrombotic events within 6 months prior to surgical operation, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \\> 38.5℃ occurring during the screening period, except for tumor fever;\n* 5\\. Patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;\n* 6\\. Participate in other clinical trials within 28 days prior to the first dose of this study, or planning to participate in this study and other clinical trials at the same time;\n* 7\\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 8.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",{"count":274,"type":20},31,[140],"This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period.\n\nThe study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an \"autologous tumor-infiltrating lymphocyte therapy\" regimen that includes：\n\n1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine).\n2. GT101 infusion.\n3. post-infusion treatment (interleukin-2 intravenous push).",[278],"Solid Tumors, Adult",{"date":166,"type":31},{"date":281,"type":31},"2022-05-23",{"date":30,"type":20},{"name":37,"class":38},5,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},"100546670","autologous-tumor-infiltrating-lymphocyte-gt307-injection--for-treatment-of-patients-with-solid-tumours-100546670","NCT06397963","Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours","A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to comply with the study protocol.\n* 2\\. Aged 18-70 years old (eligibility for subjects over 70 years old shall be jointly determined by the investigator and the medical monitor of the collaborating party).\n* 3\\. Diagnosed as patients with advanced solid tumors who have failed standard treatment, have no available standard treatment, or are unable to receive standard treatment.\n* 4\\. Having at least one lesion that is untreated with radiotherapy or other local therapies, with accessible tumor tissue (assessed by the investigator), and from which a tissue block of ≥1.0 cm³ can be isolated after resection (either from a single lesion or a combination of multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes (TILs); minimally invasive procedures should be used whenever possible.\n* 5\\. After tumor sampling, having at least one measurable lesion as defined by the RECIST v1.1 criteria, and the lesion must not have received radiotherapy or other local therapies (unless such therapies were administered more than 3 months prior and the lesion has demonstrated progression).\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 7\\. Expected survival time of ≥12 weeks.\n* 8\\. Adequate function of major organs meeting the following requirements:\n\n  1. Hematological parameters: Since the normal reference ranges may vary among different central laboratories, the final assessment shall be made by the investigator based on comprehensive judgment, with the following references:\n\n     * Absolute Neutrophil Count (ANC) ≥1.0×10⁹\u002FL;\n     * Lymphocyte Count (LC) ≥0.5×10⁹\u002FL;\n     * Platelet Count (PLT) ≥80×10⁹\u002FL;\n     * Hemoglobin (Hb) ≥90 g\u002FL.\n  2. Liver function parameters: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) ≤2.5×Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤1.5×ULN. The criteria may be relaxed under the following circumstances:\n\n     * For subjects with confirmed liver metastases: AST and\u002For ALT ≤5×ULN;\n     * For subjects with confirmed liver or bone metastases: ALP ≤5×ULN;\n     * For subjects with confirmed Gilbert's syndrome: TBIL ≤3.0 mg\u002FdL.\n  3. Renal function parameters: Creatinine Clearance Rate (CrCL) ≥45 mL\u002Fmin (calculated using the Cockcroft-Gault formula), or serum creatinine within the normal range; and urine protein \\\u003C2+.\n  4. Coagulation function parameters: Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN, and International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5×ULN simultaneously.\n  5. Adequate cardiac function.\n  6. Adequate pulmonary function.\n* 9\\. Non-surgically sterilized women of childbearing potential must agree to use at least one medically approved contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 1 year after the end of study treatment; the serum human chorionic gonadotropin (HCG) test result of such subjects must be negative within 7 days prior to cell infusion.\n* 10\\. Adverse reactions caused by prior treatments must have resolved to CTCAE 5.0 Grade ≤1 before tumor sampling, or be judged by the investigator and the collaborating medical team as having no interference with the study.\n* 11\\. For subjects enrolled in the study due to disease progression, imaging documentation confirming disease progression after the last prior treatment must be available before tumor sampling.\n\nExclusion Criteria:\n\n-1. Subjects with spinal cord compression that cannot be relieved by surgery and\u002For radiotherapy are not eligible for enrollment.\n\n(For treated subjects, enrollment is permitted if clinical evidence demonstrates that symptoms have been relieved for ≥1 week prior to surgical sampling.)\n\n* 2\\. Subjects with uncontrolled tumor-related pain as assessed by the investigator. Subjects requiring analgesic treatment must be on a stable analgesic regimen at the time of study entry. Symptomatic lesions suitable for palliative radiotherapy must be treated before study entry.\n* 3\\. A history of bleeding events occurring within 3 months prior to screening, including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased bleeding risk due to portal hypertension, active gastrointestinal bleeding, etc.; or subjects assessed by the investigator as having a high risk of major bleeding (examples include but are not limited to tumors encasing or invading major blood vessels \\[i.e., carotid artery, jugular vein, bronchial artery\\] and\u002For exhibiting other high-risk features such as fistulas, significant cavitary lesions, a history of prior bleeding \\[≤60 days from signing the ICF\\]).\n* 4\\. A history of arterial\u002Fvenous thrombotic events occurring within 3 months prior to screening, including but not limited to cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, etc.\n* 5\\. A diagnosis of interstitial pneumonia, clinically significant active pneumonia at screening, or other respiratory system diseases that severely impair pulmonary function.\n* 6\\. A history of clinically significant cardiovascular diseases, including but not limited to:\n\n  1. Congestive heart failure (NYHA classification \\> Class 2);\n  2. Unstable angina pectoris;\n  3. Myocardial infarction occurring within the past 3 months;\n  4. Any supraventricular or ventricular arrhythmias requiring treatment or intervention.\n* 7\\. Subjects with ≥3 untreated central nervous system (CNS) metastases at screening.\n\n(Enrollment is permitted if subjects have ≤3 CNS metastases, with the largest diameter \\\u003C1 cm, no peritumoral edema on brain imaging (MRI or CT), and no evidence of progressive CNS disease on brain imaging for at least 3 months after treatment.)\n\n* 8\\. A history of autoimmune diseases, or active autoimmune diseases requiring treatment with systemic corticosteroids or immunosuppressive agents (\\>10 mg\u002Fday of prednisone or equivalent).\n* 9\\. Presence of refractory or intractable epilepsy, massive pleural effusion, ascites, pericardial effusion uncontrolled by medication, active gastrointestinal bleeding, or contraindications to IL-2 administration.\n* 10\\. A history of malignant tumors other than the target indication within 5 years prior to screening (excluding adequately treated basal cell or squamous cell skin cancer, surgically resected ductal carcinoma in situ of the breast, etc.), unless the investigator determines that the potential benefits to the subject outweigh the risks.\n* 11\\. A history of infectious diseases within 1 year prior to screening, such as HIV, syphilis, active viral hepatitis, active tuberculosis, active EBV and\u002For CMV infection; or a history of active tuberculosis infection for more than 1 year without standard treatment. Subjects with active hepatitis B or C are excluded.\n\nHBsAg- or HBcAb-positive subjects may participate in the study if their HBV DNA test result is below the lower limit of normal (LLN) of the testing laboratory at the study site.\n\nHCV antibody-positive subjects may participate if their HCV RNA test result is below the LLN of the testing laboratory at the study site.\n\nFor carriers enrolled in the study, antiviral treatment should be arranged as appropriate, and regular nucleic acid copy number quantitative testing should be performed during the study period.\n\n* 12\\. Subjects with a history of prior allogeneic bone marrow transplantation or solid organ transplantation.\n* 13\\. Use of anti-angiogenic agents (e.g., bevacizumab, a VEGF inhibitor) within 4 weeks prior to sampling.\n* 14\\. Receipt of systemic anti-tumor therapy within 4 weeks prior to lymphodepletion conditioning, except for the following circumstances:\n\n  * Bridge therapy;\n  * If prior treatment included nitrosourea or mitomycin chemotherapy, the interval between the end of chemotherapy and the expected first study treatment administration must be at least 6 weeks for enrollment;\n  * If prior treatment included small-molecule targeted therapy, the interval between the end of treatment and the expected first study treatment administration must be at least 5 half-lives of the drug for enrollment.\n* 15\\. Prior receipt of genetically modified or edited cell therapy products (excluding autologous immune cell therapy products without genetic modification or editing that were administered more than 1 year before the date of cell infusion).\n* 16\\. A history of hypersensitivity reactions to any component of the drugs intended for use in the study, including but not limited to autologous tumor-infiltrating lymphocytes (TILs), cyclophosphamide, fludarabine, interleukin-2 (IL-2), dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, and antibiotics (β-lactam antibiotics, gentamicin).\n* 17\\. A known history of mental illness, alcoholism, drug addiction, or substance abuse, etc.\n* 18\\. A history of grade 3 or higher adverse reactions from prior immunotherapy that failed to resolve to CTCAE Grade 1 or lower within 28 days; any disease or condition (including other illnesses, metabolic disorders, physical examination findings, or abnormal laboratory test results) that would reasonably raise suspicion of contraindicating the use of study drugs, interfere with the interpretation of study results, or place the subject at high risk of treatment-related complications.\n* 19\\. Pregnant or lactating women; or women planning to become pregnant, lactate, or conceive within 1 year after cell infusion.\n* 20\\. Receipt of other investigational drugs\u002Fstudy treatments within 4 weeks prior to screening, or plans to participate in other investigational drugs\u002Fstudy treatments during the study period.\n* 21\\. Other circumstances deemed unsuitable for enrollment by the investigator.",{"count":138,"type":20},[95],"This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).",[144],"2026-01-23",{"date":298,"type":31},"2026-01-26",{"date":300,"type":31},"2024-04-18",{"date":302,"type":20},"2027-04-18",{"name":37,"class":38},3,{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":39},"100603033","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt719-universal-cell-injection-in-adult-participants-with-relapsedrefractory-cd19-positive-b-cell-malignant-hematological-tumors-100603033","NCT07131254","A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in Adult Participants With Relapsed\u002FRefractory CD19-positive B-cell Malignant Hematological Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.\n* 2\\. Aged 18 to 75 years (inclusive), regardless of gender.\n* 3\\. Participants with refractory or relapsed acute B-cell lymphoblastic leukemia or B-cell lymphoma diagnosed according to the WHO 2016 classification.\n* 4\\. CD19 positivity confirmed by flow cytometry and\u002For histopathology.\n* 5\\. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.\n* 6\\. Expected survival period \\> 12 weeks;\n* 7\\. For any prior systemic therapy (excluding immune checkpoint inhibitors), at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed before the participant is scheduled to receive the study treatment. For any prior treatment with immune checkpoint inhibitors (such as anti-PD-1 or anti-PD-L1 monoclonal antibodies like Pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), at least 3 half-lives or 28 days (whichever is shorter) must have passed before the participant is scheduled to receive the study treatment.\n* 8\\. Toxicities caused by prior treatments must be stable and resolved to grade ≤ 1, excluding clinically insignificant toxicities such as alopecia.\n* 9\\. Have adequate renal, hepatic, pulmonary, and cardiac functions, defined as follows:\n\n  1. . Creatinine Clearance (estimated by the Cockcroft-Gault formula) ≥ 60 mL\u002Fmin;\n  2. . Serum alanine aminotransferase\u002Faspartate aminotransferase (ALT\u002FAST) ≤ 2.5 times the Upper Limit of Normal (ULN);\n  3. . Total bilirubin ≤ 1.5 mg\u002Fdl, excluding participants with Gilbert syndrome;\n  4. . Cardiac ejection fraction ≥ 50%, no signs of pericardial effusion detected by Echocardiography (ECHO), and no clinically significant abnormalities found on Electrocardiogram (ECG);\n  5. . No clinically significant pleural effusion;\n  6. . Baseline oxygen saturation \\> 92% when measured under room air conditions.\n* 10\\. Female participants of childbearing potential must have a negative result from a serum or urine pregnancy test. Females who have undergone surgical sterilization or been postmenopausal for at least 2 years are not considered to be of childbearing potential. They must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment, and are strictly prohibited from donating oocytes within 1 year after the infusion of the study treatment during the study period.\n* 11\\. Male participants who have active sexual life with females of childbearing potential must agree to use highly effective and reliable contraceptive methods for 1 year after receiving the study treatment. All male participants are strictly prohibited from donating sperm within 1 year after the infusion of the study treatment during the study period.\n\nExclusion Criteria:\n\n* 1\\. Participants with a history of central nervous system (CNS) leukemia\u002Flymphoma, or those with CNS leukemia\u002Flymphoma shown by magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) intracranial imaging during the screening period, or those with detected malignant cells in cerebrospinal fluid or brain metastases.\n* 2\\. History of testicular leukemia\u002Flymphoma, and imaging examinations during the screening period suggest active testicular leukemia\u002Flymphoma.\n* 3\\. History of other untreated malignant tumors within the past 5 years or concurrent with the current disease, excluding adequately treated carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or ≤T1 urothelial carcinoma. Participants with prostate cancer undergoing active surveillance are eligible for this study;\n* 4\\. Hematopoietic stem cell transplantation with curative intent performed within 6 weeks prior to the planned infusion of GT719 cells;\n* 5\\. For participants with a history of hematopoietic stem cell transplantation, ≤6 months have elapsed since they received allogeneic hematopoietic stem cell transplantation;\n* 6\\. History of CD19 CAR-T\u002FNK therapy (except for participants who have received GT719 and are eligible for retreatment);\n* 7\\. Received systemic glucocorticoid drugs within 7 days before cell infusion, except inhaled glucocorticoids.\n* 8\\. History of allergic reactions to any components of the drugs intended for use in the study (including but not limited to the study drug GT719 cell infusion preparation, cyclophosphamide, and fludarabine).\n* 9\\. Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections, or infections requiring management with intravenous (IV) antimicrobial agents;\n* 10\\. Positive results for any of the following tests: Human Immunodeficiency Virus (HIV) antibody, Treponema pallidum antibody, Cytomegalovirus (CMV) IgM, Epstein-Barr Virus (EBV) IgM;\n* 11\\. Active hepatitis B and\u002For active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (anti-HBc) but with HBV-DNA levels within the normal range may be included;\n* 12\\. Presence of any indwelling lines or drainage catheters (e.g., percutaneous nephrostomy tubes, indwelling Foley catheters, biliary drainage tubes, or pleural\u002Fperitoneal\u002Fpericardial catheters). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are permitted;\n* 13\\. Presence or history of central nervous system (CNS) disorders, such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS;\n* 14\\. Participants with lymphoma involvement of the cardiac atria or ventricles.\n* 15\\. Presence of any of the following within 6 months prior to signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV, see Appendix III), angina pectoris, myocardial infarction, cardiomyopathy, stroke (excluding lacunar infarction), coronary\u002Fperipheral artery bypass surgery, clinically significant arrhythmias (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (QTc ≥500 ms corrected by the Bazett's method, as specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg), poorly controlled diabetes mellitus, pulmonary embolism, diffuse pulmonary lesions, impaired pulmonary function, or any medical condition deemed by the investigator to be unsuitable for participation in this clinical study;\n* 16\\. Participants for whom urgent treatment is expected or likely to be required within 6 weeks due to ongoing or impending tumor emergencies (e.g., tumor mass effect, tumor lysis syndrome);\n* 17\\. Primary immunodeficiency.\n* 18\\. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy;\n* 19\\. Any medical condition that may interfere with the assessment of the safety or efficacy of the study treatment;\n* 20\\. Vaccination with live attenuated vaccines or mRNA vaccines within 8 weeks prior to lymphodepleting conditioning, or inactivated vaccines within 4 weeks prior;\n* 21\\. Females of childbearing potential who are pregnant or breastfeeding. Females who have undergone sterilization surgery or been postmenopausal for at least 2 years are not considered to be of childbearing potential;\n* 22\\. Male and female participants who are unwilling to use contraception from the time of informed consent until 6 months after the completion of treatment.\n* 23\\. Participants who, in the judgment of the investigator, are unlikely to complete all protocol-required study visits or procedures, including follow-up, or to comply with the requirements of study participation;\n* 24\\. History of autoimmune diseases within the past 2 years that have caused end-organ damage or required systemic immunosuppressive agents\u002Fsystemic disease-modifying agents (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).",{"count":312,"type":20},34,[23],"This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed\u002Frefractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 34 subjects will be enrolled in this study.",[316],"Hematological Malignancy (Leukemia- Lymphoma)","2025-12-24",{"date":319,"type":31},"2025-12-30",{"date":321,"type":31},"2025-03-10",{"date":323,"type":20},"2027-12-01",{"name":37,"class":38},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":91,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":333,"briefSummary":334,"conditions":335,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":39},"100522888","phase-1-til-injection-for-the-treatment-of-metastatic-or-recurrent-solid-tumors-100522888","NCT06088472","TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors","A Single-arm Phase I Clinical Study of TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in the study, sign the informed consent form, and be willing and able to follow the study protocol ;\n* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;\n* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies, and at least tissue blocks with a volume of≥0.5 cubic centimeter (either of single lesion origin or multiple lesions combined) can be isolated for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;\n\nExclusion Criteria:\n\n* 1\\. Patients who have symptomatic and\u002For untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);\n* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\\>10 mg\u002Fday of prednisone or equivalent hormone) within 14 days before lymphocyte depletion chemotherapy;\n* 3\\. Arterial\u002Fvenous thrombotic events within 6 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;\n* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \\> 38.5℃ occurring during the screening period, except for tumor fever;\n* 5\\. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;\n* 6\\. Patients who have received allogeneic bone marrow transplantation or an organ allograft;\n* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);",{"count":199,"type":20},[140],"This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.",[278],"2025-09-23",{"date":338,"type":31},"2025-09-29",{"date":340,"type":31},"2021-04-21",{"date":342,"type":20},"2027-12-31",{"name":37,"class":38},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":46,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":39},"100602328","early-phase-1-gt719-injection-for-moderate-to-severe-refractory-autoimmune-diseases-100602328","NCT07122076","GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases","A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases","Inclusion Criteria\n\n1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.\n2. Aged 18 to 65 years (inclusive), regardless of gender.\n3. The functions of important organs meet the following requirements，excluding those attributable to disease activity:\n\n   1. Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×10\\^9\u002FL; Hemoglobin ≥80g\u002FL; Platelets ≥30×10\\^9\u002FL;\n   2. Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;\n   3. Renal function: creatinine clearance (CrCl) ≥30 ml\u002Fminute;\n   4. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;\n   5. Heart function: good hemodynamic stability, with no evidence of moderate or greater pericardial effusion.\n4. Women of childbearing age must:\n\n   1. During screening, the test result for serum β-human chorionic gonadotropin (β-hCG) was negative;\n   2. Agree to avoid breastfeeding during the study period until at least one year after the infusion of GT719 cell injection or until two consecutive flow cytometry tests show the absence of GT719 cells (whichever occurs later);\n   3. Male participants with sexual partners and female participants with potential fertility agree to use highly effective contraceptive methods from screening until at least one year after GT719 cell injection or until two consecutive flow cytometry tests show the absence of GT719 cells (whichever occurs later). Male participants must agree to use condoms during sexual contact with pregnant or fertile women for at least one year after infusion of GT719 cell injection, even after successful vasectomy.\n\nSpecific inclusion criteria:\n\nSystemic lupus erythematosus\n\n1. Complies with the classification standards of the 2019 European Union Against Rheumatology\u002FAmerican Society of Rheumatology (EULAR\u002FACR) SLE;\n2. Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;\n3. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nInflammatory myopathy\n\n1. Inflammatory myopathy fulfilling the 2017 EULAR\u002FACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).\n2. Positive myositis antibodies;\n3. Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN; or MMT-8 ≥ 142, but with active interstitial lung disease (HRCT showing ground-glass opacities);\n4. Definition of relapsed\u002Frefractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and cyclophosphamide, and any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.\n5. Definition of progressive: Rapid progression of interstitial lung disease within a short period.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nDiffuse systemic sclerosis\n\n1. Meet the 2013 ACR classification criteria for systemic sclerosis;\n2. Positive antibodies related to systemic sclerosis;\n3. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n4. Definition of progression: rapid skin progression (mRSS increase \\>25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).\n\nNote: Articles 4 and 5 satisfy one or the other.\n\nExclusion Criteria:\n\n1. SLE participants:\n\n   1. Drug induced SLE;\n   2. Patients with lupus crisis or concomitant diseases who require the use of contraindicated drugs according to the protocol are deemed unsuitable for inclusion by the investigator.\n2. IIM participants\n\n   1. Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor associated PM or DM, non-inflammatory myopathy (such as muscular dystrophy);\n   2. Uncontrolled extramuscular disease damage related to PM or DM:\n\n   ILD: FVC\\\u003C55% or requiring oxygen therapy;\n\n   Severe swallowing difficulties, as determined by investigator, increase the risk of patients participating in clinical trials;\n\n   Severe cardiac manifestations (such as congestive heart failure, arrhythmia, conduction abnormalities requiring treatment, or myocardial infarction) have been determined by investigator to increase the risk of patients participating in clinical trials.\n3. SSc participants\n\n   1. Moderate to severe pulmonary arterial hypertension (PAH) associated with SSc that cannot be controlled by drug therapy;\n   2. Rapid progressive SSc related low gastrointestinal (small and large intestine) involvement (requiring parenteral nutrition); Active dilation of gastric antral blood vessels;\n   3. Uncontrolled or rapidly progressing ILD with oxygen saturation (SaO2) \\\u003C92% (in still indoor air); Or require mechanical respiratory assistance (ventilator) within one year prior to signing the informed consent form.\n4. Has a history of severe hypersensitivity reactions or allergies;\n5. Contraindications or hypersensitivity reactions to any components of fludarabine, cyclophosphamide, and experimental drugs;\n6. Suffering from the following heart diseases:\n\n   1. NYHA Grade III or IV congestive heart failure;\n   2. Has experienced a myocardial infarction or undergone coronary artery bypass surgery within the 6 months prior to the screening period;\n   3. A clinically significant history of ventricular arrhythmia or unexplained syncope, not caused by vasovagal nerve response or dehydration, or a corrected QT interval (QTc)\\>480 ms during screening;\n   4. History of severe non ischemic cardiomyopathy;\n7. Any active malignant tumors or history of malignant tumors within the past 5 years before screening. Excluding the following situations: early-stage tumors that have received curative treatment (in situ or stage I tumors, non ulcerative primary melanoma with a depth of\\\u003C1 mm and no involvement of lymph nodes), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical in situ cancer, or breast in situ cancer that has received potential curative treatment;\n8. Individuals with clinically significant bleeding symptoms or clear bleeding tendencies within the 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc; Hereditary or acquired bleeding and thrombophilia tendencies (such as hemophilia, coagulation dysfunction, splenic hyperfunction, etc.); Occurrence of arteriovenous thrombosis events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and\u002For pulmonary embolism;\n9. When screening, there may be serious underlying medical conditions, such as:\n\n   1. There is evidence to suggest the presence of uncontrollable viruses, bacteria, fungi, or other infections that require systemic intravenous treatment;\n   2. There is clear clinical evidence indicating the presence of dementia or changes in mental state;\n   3. Any other history of central nervous system disorders or neurodegenerative diseases, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, mental illness;\n10. Any of the following test results is positive:\n\n    1. Positive for human immunodeficiency virus (HIV) antibodies;\n    2. Hepatitis B surface antigen (HBsAg) positive; Or if the hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus (HBV) - DNA is higher than the detection limit of the analytical method;\n    3. Hepatitis C virus (HCV) antibody positive and HCV RNA above the detection limit of the analytical method;\n    4. Syphilis antibody positive (false positive result due to reasons other than the disease);\n11. Cytomegalovirus (CMV) (DNA) and Epstein Barr virus (EBV) (DNA) tests positive;\n12. Active tuberculosis or latent tuberculosis without proper treatment before screening;\n13. Received other clinical trial drugs within 4 weeks prior to the signing of the informed consent form (ICF), or the ICF signing date is within 5 half lives of the drug from the last use of the drug in the previous clinical trial (whichever is longer);\n14. Received plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to lymphodepleting chemotherapy;\n15. Used drugs targeting B cells, including but not limited to rituximab, belimumab, tacrolizumab, etc., within one week before lymphodepleting chemotherapy;\n16. Used tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolate mofetil, methotrexate, etc. within 2 weeks before lymphodepleting chemotherapy;\n17. Used neonatal Fc receptor (FcRn) antagonist therapy (such as Efgartigimod) within 3 weeks before lymphodepleting chemotherapy;\n18. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;\n19. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;\n20. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;\n21. Medical history of organ transplantation;\n22. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);\n23. According to the investigator's judgment, the situations that hinder participants from participating in the entire trial, confound the trial results, or participate in the trial that are not in the best interests of the participants.",{"count":352,"type":20},10,[23],"This study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study.",[356],"Autoimmune Diseases","2025-09-16",{"date":359,"type":31},"2025-09-22",{"date":361,"type":31},"2025-08-22",{"date":363,"type":20},"2028-08-21",{"name":37,"class":38},{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":372,"targetDuration":4,"studyType":21,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":39},"100589020","phase-1-gt719-injection-for-the-treatment-of-recurrentrefractory-cd19-positive-adult-b-cell-malignancies-100589020","NCT06948981","GT719 Injection for the Treatment of Recurrent\u002FRefractory CD19 Positive Adult B-cell Malignancies","A Single-arm, Open-label, Phase I\u002FII Clinical Study of GT719 Injection for Recurrent\u002FRefractory CD19 Positive Adult B-cell Malignancies","Inclusion Criteria:\n\n1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.\n\n   \\-\n2. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.\n\n   \\-\n3. CD19 positivity confirmed by flow cytometry and\u002For histopathology.\n\nExclusion Criteria:\n\n1. Primary immunodeficiency.\n\n   \\-\n2. History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.\n\n   \\-\n3. Any medical condition that may interfere with the evaluation of the safety or effectiveness of research and treatment;",{"count":373,"type":20},46,[140,141],"This study is a prospective single-arm open-labled phase I\u002FII clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in relapsed\u002Frefractory CD19 positive adult B-cell non Hodgkin lymphoma (B-NHL) and B-acute lymphoblastic leukemia (B-ALL) patients. A total of 46 subjects (anticipated) will be enrolled in this study.",[316],"2025-09-10",{"date":357,"type":31},{"date":380,"type":31},"2025-04-18",{"date":382,"type":20},"2028-04-17",{"name":37,"class":38},{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":39},"100594573","phase-1-gt719-injection-for-recurrentrefractory-antibody-mediated-neurological-immune-diseases-100594573","NCT07021209","GT719 Injection for Recurrent\u002FRefractory Antibody-mediated Neurological Immune Diseases","A Single-arm, Open-label, Phase I Clinical Study of GT719 Injection for Recurrent\u002FRefractory Antibody-mediated Neurological Immune Diseases","Inclusion Criteria:\n\n* Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.\n* Expected survival period\\>12 weeks.\n* Any previous systemic treatment must have undergone at least 4 weeks or 5 half lives (whichever is shorter) by the time the participant plans to receive the study treatment.\n\nExclusion Criteria:\n\n* History of organ transplantation, splenectomy, and allogeneic or autologous stem cell transplantation.\n* History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulant therapy.\n* Received systemic corticosteroids at a dose of ≥10 mg\u002Fday prednisone equivalent within 7 days prior to GT719 infusion, except for inhaled corticosteroids.",{"count":114,"type":20},[140],"This study is an open-label, prospective, exploratory clinical trial that includes a dose escalation phase and a dose expansion phase, aimed at evaluating the safety, cell dynamics, and preliminary efficacy of GT719 cells in adult participants with recurrent\u002Frefractory antibody-mediated neurological immune diseases.",[395],"Neurological Autoimmune Diseases","2025-09-08",{"date":398,"type":31},"2025-09-15",{"date":400,"type":31},"2025-01-14",{"date":402,"type":20},"2028-01-13",{"name":37,"class":38},""]