[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Maximum Bio-tech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100573154","phase-1-study-of-mt027-in-patients-with-brain-meninges-and-spinal-cord-metastatic-solid-tumors-100573154",false,"NCT06742593","Study of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors","A Single-arm, Dose-escalating Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic , and Efficacy of MT027 in Patients with Brain, Meninges, and Spinal Cord Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily participate in this study and provide a signed and dated written informed consent form prior to any study-specific procedures, sampling or analyses.\n2. Be aged 18 years or older, with no limitation on gender.\n3. Have a definite diagnosis of malignant tumor confirmed by pathology and\u002For histology (and provide complete pathological report information), and have been verified by biopsy, cytology, imaging examinations, etc. or have had previous confirmation of brain, meninges, spinal cord metastases, including lung cancer, breast cancer, colorectal cancer, melanoma, renal cell carcinoma, etc. Other solid tumor CNS metastases without standard treatment as judged by the investigator can also be considered for enrollment.\n4. The expected survival period is at least 3 months.\n5. The Karnofsky Performance Scale (KPS) score is ≥ 70 points. -\n\nExclusion Criteria:\n\n1. Known to be allergic to the investigational drug or its excipient components;\n2. Those with central nervous system metastases of hematological malignancies (such as lymphoma, leukemia, etc.);\n3. Those with metastases in the brainstem and high cervical spinal cord, including the midbrain, pons, medulla oblongata and C1\u002F2 cervical spinal cord segments;\n4. Those with severe insufficiency of heart, lung, liver and kidney functions; cardiac function: grade III or above according to the New York Heart Association (NYHA) criteria; liver function: grade C or above according to the Child-Pugh grading criteria; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms involving other organs;\n5. Pregnant or lactating women;\n6. Those who are considered by the investigator to be unsuitable for participating in this clinical study due to any clinical or laboratory examination abnormalities or other reasons.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","MT027 is an off-the-shelf, allogeneic chimeric antigen receptor T cell (UCAR-T) injection prepared from healthy donor T cells targeting B7-H3. It is a next-generation, ready-to-use CAR-T product that can be used immediately and promptly for patients to solve the problem of unmet medical needs for a large number of patients who have a demand for CAR-T therapy but cannot receive it due to the common reasons of long production cycle, insufficient production capacity, and incompatibility of patients' T cells with the production conditions. In addition, the expected medical cost of allogeneic CAR-T cells is significantly lower, which can greatly alleviate the economic burden on patients.\n\nMT027 is prepared by expressing a chimeric antigen receptor (CAR) targeting B7H3 on gene-edited T cells through gene modification technology. MT027 products targeting the B7H3 target developed by Moxing Biotech avoid the potential graft-versus-host disease (GvHD) and host anti-graft reaction (HvGR) caused by the interaction between exogenous T cells and the patient's immune system, and have shown good safety and efficacy in recurrent high-grade glioma in the initial phase.",[26,27,28],"Brain (Nervous System) Cancers","Brain and Central Nervous System Tumors","Brain Tumors","NOT_YET_RECRUITING","2024-12-17",{"date":32,"type":33},"2024-12-19","ACTUAL",{"date":35,"type":20},"2025-01-01",{"date":37,"type":20},"2026-12-30",{"name":39,"class":40},"Suzhou Maximum Bio-tech Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":61,"leadSponsor":62,"locationsCount":41},"100572736","phase-1-study-of-mt027-in-patients-with-recurrent-or-progressive-high-grade-glioma-100572736","NCT06737146","Study of MT027 in Patients with Recurrent or Progressive High-grade Glioma","A Single-arm, Dose-escalation Phase I Clinical Study on Evaluating the Tolerability, Pharmacokinetic Characteristics, Safety and Preliminary Efficacy of MT027 in Patients with Recurrent or Progressive High-grade Glioma","Inclusion Criteria:\n\n1. Voluntarily participate in this study and sign the informed consent form.\n2. Be aged between 18 and 70 years old (including the critical values), with no gender limitation.\n3. Subjects with high-grade glioma diagnosed pathologically (referring to grade 3 or 4 in the \"WHO (2021) Classification of Tumors of the Central Nervous System\"), who have progressive disease during standard treatment or have recurrence after standard treatment.\n4. Enhanced MRI shows space-occupying lesions in the brain, and there is at least one measurable lesion (according to the iRANO 2010 version criteria).\n5. The tumor tissue of the patient has positive expression of B7-H3. The subject voluntarily provides the most recent formalin-fixed paraffin-embedded (FFPE) tissue or pathological sections (at least 8 consecutive blank sections) for the detection of B7-H3 expression (immunohistochemistry, IHC).\n6. Have an expected survival period of ≥ 3 months.\n7. Have a Karnofsky Performance Scale (KPS) score of ≥ 70 points. -\n\nExclusion Criteria:\n\n1\\. Patients with recurrence in the brainstem, spinal cord dissemination or extracranial metastasis; 2. The maximum diameter of a single tumor lesion is \\> 5 cm, or the cumulative maximum diameter of multiple lesions is \\> 6 cm; 3. Having received radiotherapy within 3 months before cell therapy or having received surgical treatment (except for Ommaya reservoir implantation), chemotherapy (except for lymphocyte depletion therapy), immunotherapy, molecular targeted therapy or any other anti-tumor therapy within 4 weeks before cell therapy; 4. Having participated in other drug clinical trials within 4 weeks before screening; 5. Having previously received CAR-T cell therapy; 6. Subjects with a severe allergy history to any component of the experimental drug or biological products; 7. Subjects with other primary malignancies (except for cured cervical carcinoma in situ and basal cell carcinoma of the skin); 8. Suffering from major diseases such as active systemic infection and coagulation disorders; 9. Suffering from severe insufficiency of heart, lung, liver and kidney functions; cardiac function: grade III or above according to the New York Heart Association (NYHA) criteria; liver function: grade C or above according to the Child-Pugh grading criteria; renal function: chronic kidney disease (CKD) stage 4 or above; renal insufficiency stage III or above; pulmonary function: severe respiratory failure symptoms involving other organs; 10. Subjects with severe autoimmune diseases; 11. Subjects who have previously received allogeneic tissue\u002Fsolid organ transplantation; 12. Subjects who have received live vaccines within 2 weeks before the first cell therapy or who plan to receive live vaccines during the study period; 13. Subjects with active hepatitis B virus infection; or patients with hepatitis C virus infection (defined as positive HCV antibody, and those with HCV-RNA below the detection limit are allowed to enroll); or patients with human immunodeficiency virus infection (defined as positive HIV antibody); or patients with positive treponema pallidum antibody; 14. Having symptoms and signs of epilepsy or chronic intracranial hypertension that are difficult to control with drugs (for example, those using more than 500 ml of mannitol or more than 15 mg of dexamethasone or more than 80 mg of methylprednisolone or other hormones in equivalent doses per day); 15. Subjects judged by the investigator to have severe neurocognitive disorders; 16. Pregnant or lactating women; 17. Those who are considered by the investigator to be unsuitable for participating in this clinical study due to any clinical or laboratory examination abnormalities or other reasons.\n\n\\-","70 Years",{"count":19,"type":20},[23],"The clinical protocol plans to preset three dose groups, namely 1×10⁷ cells per dose, 3×10⁷ cells per dose, and 6×10⁷ cells per dose. The injection will be administered once every three weeks, adopting a \"3 + 3\" dose escalation design. The dosing interval is based on the pharmacokinetic (PK), safety and preliminary efficacy data of MT027 investigator-initiated trial (IIT) previously conducted at Dushu Lake Hospital of Soochow University. Accordingly, it is recommended to maintain the dosing interval of once every three weeks, with a window period of ±7 days. According to past experience, the dosing cycle should be at least 6 cycles, with each cycle lasting 21 days. If patients still benefit after more than 6 cycles, they can continue to receive the medication until no further benefit is achieved. The number of treatment sessions is approximately 6 to 9 times. However, the specific number of treatment sessions will generally be determined by the investigator based on the patient's disease condition.",[54],"High-grade Glioma",[56,57],"MT027","High-grade glioma","2024-12-11",{"date":30,"type":33},{"date":35,"type":20},{"date":37,"type":20},{"name":39,"class":40},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":81,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100571923","phase-1-a-study-of-mt027-in-patients-with-pleural-malignant-tumors-100571923","NCT06726564","A Study of MT027 in Patients with Pleural Malignant Tumors","A Phase 1 Single Arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT027 in Patients with Pleural Malignant Tumors","Inclusion Criteria:\n\n1. voluntarily participate in the study and sign informed consent;\n2. age over 18 years old (including the cut-off value), regardless of gender;\n3. advanced malignant solid tumor pathologically and\u002For histologically diagnosed with malignant pleural effusion requiring drainage confirmed by histopathology or cytopathology (metastatic or primary);\n4. the original pleural cavity malignant tumor after standard treatment failure, or top treatment;\n5. signed informed consent not line within a month before the chest cavity medicine injection, but does not exclude the diagnostic puncture;\n6. The subjects voluntarily provided sufficient tumor cells in the pathological section of the primary lesion and\u002For pleural effusion for B7-H3 expression detection, and the tumor cells in the pathological section of the primary lesion or malignant pleural effusion were positive for B7-H3 expression;\n7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2;\n8. within 7 days before treatment laboratory meet the following criteria:\n\nRoutine blood (14 days) :\n\n1. Absolute neutrophil count (ANC) ≥1.5×109 \u002FL;\n2. platelet count (PLT) or 80 x 109 \u002F L;\n3. hemoglobin (HGB) or 80 g\u002FL (allowing blood transfusion and use erythropoiesis agent). The presence of active bleeding or other ongoing conditions that result in increased red-cell destruction or impaired production may require repeated transfusions or red-cell therapy, and patients had to discuss their eligibility with the sponsor on an individual basis before enrollment.) ;\n\nLiver:\n\n1. total bilirubin (TIBC) or less 2 times the upper limit of the normal range (ULN);\n2. no liver metastasis, AST and ALT 3 x ULN or less; ALT and AST≤5 times ULN in the presence of liver metastasis;\n\nKidney:\n\n1. Serum creatinine (Cr) ≤ 2 times ULN; Or creatinine clearance (CrCL) ≥ 50 mL\u002Fmin (estimated by Cockcroft-Gault formula);\n\n   Blood coagulation function:\n2. international standardization ratio (INR) or prothrombin time (PT) 1.3 x ULN or less;\n3. Partial activated thromboplastin time (APTT) ≤ 1.5 times ULN; 9) toxicity from previous systemic therapy returned to grade 1 or less or to baseline before the first dose (except alopecia); 10) Fertile men and women of childbearing age must agree to use reliable contraception from the time they provide informed consent until 180 days after the last dose of MT027 cell injection; Women of childbearing age included those who were premenopausal and those within 2 years of menopause.\n\nExclusion Criteria:\n\n1. known allergy to the study drug or its excipients;\n2. patients with pleural puncture contraindications or won't benefit from intrathoracic medication;\n3. any antineoplastic drugs other than systemic antineoplastic therapy that the subject has been taking stably and any treatment that may have an effect on the control of pleural effusion (other than diagnostic puncture or thoracentesis for investigational treatment);\n4. in the first test within 2 weeks before treatment received radiotherapy.\n5. major surgery is performed within 4 weeks before the first trial treatment and the patient has not fully recovered;\n6. are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week before the first trial treatment.\n7. participated in other drug clinical trials within 4 weeks before screening;\n8. always had targeted B7 - H3 CAR - T cells treatment;\n9. patients with active systemic or pulmonary infection, coagulopathy and other major diseases;\n10. with severe heart, lung, liver and renal insufficiency; Cardiac function: grade 3 or above according to the New York Heart Association (NYHA) criteria; Liver function: Child - Puge classification standard for grade C or above; Renal function: chronic kidney disease (CKD) stage 4 or above; Renal insufficiency stage Ⅲ or above; Pulmonary function: severe symptoms of respiratory failure involving other organs;\n11. patients with severe autoimmune diseases;\n12. recipients of previous allogeneic tissue\u002Fsolid organ transplantation;\n13. who received a live vaccine within 2 weeks before the first cell therapy or were scheduled to receive a live vaccine during the study;\n14. active HBV infection; Or hepatitis C virus infection (defined as positive for HCV antibody, allowed if HCV-RNA was below the lower limit of detection); Or human immunodeficiency virus infection (defined as HIV antibody positive); Or positive treponema pallidum antibody;\n15. subjects had severe neurocognitive impairment as judged by the investigator;\n16. pregnant or lactating women;\n17. There were any clinical or laboratory abnormalities or other reasons considered by the investigator to preclude participation in the study.",{"count":71,"type":20},18,[23],"This is a phase I open label, single-arm, dose-escalation study to evaluate the feasibility, safety, tolerability, PK\u002FPD, and to determine RP2D of MT027 via an locoregional delivery in subjects with pleural malignant tumors, who have previously received standard of care therapy..\n\nSubjects meeting the study entry criteria including having tumor antigen B7H3 overexpression via immunohistochemistry (IHC ) will be enrolled and assigned to cohorts sequentially to receive study treatments, assessments, as well as post-treatment safety follow-ups in the study.",[75,76,77,78,79,80],"Advanced Malignant Solid Tumor","Malignant Pleural Effusion","Pleura Carcinoma","Pleural Mesothelioma","Pleural Malignant Mesothelioma","Pleural Metastases",[82,83,84],"advanced malignant solid tumors","metastatic or primary malignant tumors in the pleural cavity","malignant pleural effusion","RECRUITING","2024-12-05",{"date":88,"type":33},"2024-12-10",{"date":90,"type":33},"2024-05-15",{"date":92,"type":20},"2029-02",{"name":39,"class":40},""]