[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tcelltech Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100596969","phase-1-safety-and-efficacy-of-dit309-in-advanced-bone-and-soft-tissue-sarcomas-100596969",false,"NCT07052383","Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing and able to comply with all study procedures.\n2. Male or female patients aged ≥8 weeks.\n3. Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.\n4. At least one measurable lesion as defined by RECIST version 1.1.\n5. Tumor tissue demonstrates positive expression for the target antigen according to the protocol-defined criteria.\n6. ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.\n7. Life expectancy of more than 6 months.\n8. Adequate venous access for leukapheresis, with no contraindications for the procedure.\n9. Laboratory parameters must meet the following criteria:\n\n   1. Hematologic function: WBC ≥ 3.0 × 10⁹\u002FL; Hemoglobin ≥ 8.0 g\u002FdL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75.0 × 10⁹\u002FL\n   2. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n   3. Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)\n   4. Total bilirubin ≤ 2.0 × ULN (excluding patients with Gilbert's syndrome, defined as persistent or recurrent unconjugated hyperbilirubinemia without evidence of hemolysis or hepatic pathology)\n   5. Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN\n   6. Negative pregnancy test for female subjects of childbearing potential\n10. Subjects of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Viral infections:\n\n   1. Positive serology for HIV antibodies or syphilis\n   2. Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood\n   3. Positive HCV antibody with detectable HCV RNA in peripheral blood\n3. Medical history and comorbidities:\n\n   1. Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions\n   2. Known active autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus); subjects with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; subjects requiring medical intervention such as bronchodilators for asthma are not eligible\n   3. Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)\n   4. Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy\\*\n   5. History of uncontrolled neurological or psychiatric disorders that may increase the risk of participation or interfere with study results in the investigator's opinion, including but not limited to epilepsy, dementia, or major depression\n   6. Untreated or symptomatic CNS or leptomeningeal metastases\n   7. Unresolved toxicities from prior treatment that have not recovered to Grade ≤1 per CTCAE v5.0 (except for toxicities deemed not to pose safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism managed with replacement therapy)\n   8. History of other primary solid malignancies\n   9. Major surgery or significant trauma within 1 month prior to leukapheresis\n   10. Any serious or uncontrolled comorbidity that, in the investigator's opinion, may increase risks associated with study participation or investigational drug administration, including but not limited to: cardiovascular or cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders requiring long-term anticoagulation, active or uncontrolled infections requiring systemic treatment.","ALL","8 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.",[26,27],"Osteosarcoma","Soft Tissue Sarcoma",[29],"Advanced","RECRUITING","2026-04-29",{"date":33,"type":34},"2026-05-05","ACTUAL",{"date":36,"type":34},"2025-11-06",{"date":38,"type":20},"2027-10-10",{"name":40,"class":41},"Tcelltech Inc.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":5},"100553193","phase-1-safety-and-efficacy-study-of-tx103-car-t-cell-therapy-for-recurrent-or-progressive-grade-4-glioma-100553193","NCT06482905","Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.","A Phase I, Open-Label, Single\u002FMultiple Dose, Dose-escalation Study to Evaluate the Safety, Tolerability and Antitumor Activity of TX103 CAR-T Cell Injection (TX103) in Subjects With Recurrent or Progressive Grade 4 Glioma.","Inclusion Criteria:\n\n1. Subjects must voluntarily participate in the study and sign a written informed consent document; subjects should be willing and able to follow and complete study procedures.\n2. Male or female subjects aged 18 to 75 years (both inclusive).\n3. Subject must have histologically diagnosed grade 4 glioma, such as glioblastoma, grade 4 astrocytoma, diffuse hemispheric glioma, according to 2021 WHO Classification of Tumors of the CNS. Subjects must have had experienced disease recurrence or progression\\* after surgery combined with Stupp regimen (concurrent radiotherapy and temozolomide (TMZ) followed by adjuvant TMZ) and are not candidate for re-resection. For subjects harboring specific gene mutations, such as NTRK gene fusion or BRAF V600E mutation, they must have also progressed on corresponding mutation-directed therapies before enrollment.\n\n   \\* Disease recurrence or progression must be confirmed by radiographic or histopathological diagnosis.\n4. Subjects with confirmed B7-H3 positive\\* (≥30%) tumor expression by immunohistochemistry (IHC) in either primary or recurrent tumor tissue.\n\n   \\*B7-H3 positive rate is defined as the percentage of B7-H3 positive tumor cells in non-necrotic tumor tissue.\n5. Subjects with KPS score of ≥60.\n6. Subjects should have adequate venous access for collection of peripheral blood mononuclear cells (PBMCs).\n7. Subjects with left ventricular ejection fraction (LVEF) ≥ 40% within one month prior to the first dose.\n8. Subjects with oxygen saturation ≥95% under the resting state.\n9. Subjects with adequate organ function, as indicated by laboratory test results that meet the following criteria:\n\n   * Hematological function: Absolute neutrophil count (ANC) ≥1.5×109\u002FL, hemoglobin (Hb) ≥90g\u002FL, platelet count (PLT) ≥100×109\u002FL, absolute lymphocytes count (ALC) ≥0.15×109\u002FL. Blood transfusion, granulocyte (macrophage) colony stimulating factor, recombinant human erythropoietin, recombinant human thrombopoietin, platelet receptor agonist, recombinant human interleukin-11, and other supportive treatments are prohibited within 14 days before the test.\n   * Liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN, patients with Gilbert's syndrome (persistent or recurrent hyperbilirubinemia, presenting as unconjugated bilirubin in the absence of evidence of hemolysis or liver pathology) Except for elevated erythrocytes; alanine aminotransferases (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN.\n   * Renal function: serum creatinine (Scr) ≤1.5×ULN.\n   * Coagulation function (in the absence of anticoagulant therapy): prothrombin time (PT) or activated partial thromboplastin time (APTT) or international normalized ratio (INR) ≤ 1.5×ULN.\n   * Female subjects of childbearing potential must have a negative serum pregnancy test at screening and if a positive urine test or a negative result cannot be confirmed by urine test.\n10. Women of childbearing potential (which refer to women who have not been surgically sterilized and pre-menopausal women) should use highly effective and reliable method of contraception (refer to Section 5.3 for contraception method) from the start of the study until 6 months after the last dose of the study drug; sexually active male subjects, if no vas deferens for ligation, consent must be given to the use of highly effective and reliable method of contraception from the start of the study until 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding female subjects.\n2. Subjects with viral infection during the screening period:\n\n   * Serum HIV antibody positive, treponema pallidum serology positive; OR\n   * Hepatitis B surface antigen (HBsAg) positive and peripheral blood HBV DNA test value exceeds the normal range; OR\n   * Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive.\n3. Medical history and concomitant diseases:\n\n   * Subjects who have received carmustine extended-release implantation surgery within 6 months;\n   * Subjects with known or suspected active autoimmune diseases, including but not limited to Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.;\n   * Subjects who are receiving systemic immunosuppressive agents or subjects who need to use immunosuppressive agents for a long-time during treatment, except for intermittent topical, inhaled, or intranasal glucocorticoid therapy;\n   * Subjects with uncontrolled mental disorders, or who, in the Investigator's opinion, have a medical history or a history of mental states that may increase the risks associated with study participation or study drug administration, or that may interfere with the results;\n   * The toxicity and side effects caused by previous treatment have not recovered to ≤ grade 1 (per CTCAE 5.0); except for alopecia and other tolerable events judged by the Investigator;\n   * Subjects who have participated in other interventional clinical studies within the past 1 month;\n   * Subjects who have previously received CAR-T cell therapy or other gene therapy\\*;\n   * Subjects with any serious or poorly controlled disease that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or affect the subject's ability to receive study drug, including but not limited to cardiovascular and cerebrovascular diseases, renal insufficiency, pulmonary embolism, coagulopathy or requiring long-term anticoagulant therapy, active infection or uncontrollable infection requiring long-term systemic treatment;\n   * Subjects with other malignant tumors in the past 3 years or at present, except for non-melanoma skin cancer, carcinoma in situ (such as cervix, bladder and breast cancer).","18 Years","75 Years",{"count":53,"type":20},52,[23],"This is a phase I, open-Label, single\u002Fmultiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.",[57,58],"High-grade Glioma","WHO Grade Ⅳ Glioma","2026-03-19",{"date":61,"type":34},"2026-03-24",{"date":63,"type":34},"2024-09-04",{"date":65,"type":20},"2027-06",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100630271","phase-1-safety-and-efficacy-of-dit101-in-relapsed-or-refractory-hematologic-malignancies-100630271","NCT07485504","Safety and Efficacy of DIT101 in Relapsed or Refractory Hematologic Malignancies","A Prospective, Single-Arm Study Evaluating the Safety and Efficacy of DIT101 in Subjects With Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adults aged 18 to \\\u003C70 years, any gender.\n* Voluntarily provide written informed consent and willing to comply with all study procedures.\n* Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia\u002Flymphoma (B-ALL\u002FLBL), or other relapsed\u002Frefractory hematologic malignancies as judged by the investigator and confirmed by the collaborating institution.\n* Tumor cells confirmed positive for the target antigen by immunophenotyping.\n* Bone marrow blast ≥5% at screening and\u002For presence of extramedullary disease.\n* For B-ALL\u002FLBL patients, meets criteria for relapsed\u002Frefractory disease, including:\n\n  * Primary refractory after ≥2 cycles of standard chemotherapy or not achieving CR after multiple salvage regimens;\n  * Relapse within 12 months after CR or ≥12 months relapse after CR not achieving CR after subsequent standard therapy;\n  * Relapse after hematopoietic stem cell transplantation;\n  * Relapse after prior CAR-T therapy targeting the same antigen.\n* ECOG performance status 0-2.\n* Expected survival \\>3 months.\n* Adequate organ function, including:\n\n  * Renal: creatinine clearance \\>45 mL\u002Fmin;\n  * Hepatic: total bilirubin ≤3×ULN, ALT\u002FAST ≤5×ULN;\n  * Coagulation: PT, APTT, or INR ≤1.5×ULN;\n  * Cardiac: LVEF ≥50% within 1 month;\n  * Pulmonary: SpO₂ ≥92% at rest on room air;\n  * Hematologic and immune function considered sufficient to tolerate study treatment.\n* Women of childbearing potential must have a negative pregnancy test; women considered not of childbearing potential include those who are postmenopausal for ≥12 months or have undergone surgical sterilization (hysterectomy or bilateral oophorectomy).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Known hereditary bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known marrow failure syndromes).\n* Uncontrolled active central nervous system leukemia (CNSL; CNS2 or CNS3).\n* Prior anti-cancer therapy before screening, including:\n\n  * Systemic chemotherapy within 1 week;\n  * Systemic immunotherapy\u002Ftargeted therapy (monoclonal antibodies, bispecific antibodies, ADCs, etc.) with last dose \\\u003C5 half-lives or \\\u003C4 weeks (whichever is shorter);\n  * Donor lymphocyte infusion within 6 weeks;\n  * CAR-T therapy or hematopoietic stem cell transplantation within 3 months;\n  * Radiotherapy within 4 weeks (unless bone marrow reserve \\>5% and investigator judges it does not affect eligibility);\n  * Persistent clinically significant toxicity from prior therapy not recovered to ≤CTCAE Grade 1 (except alopecia).\n* Uncontrolled severe active infection.\n* History of significant cardiac disease, including: severe heart failure (NYHA class III-IV), myocardial infarction or PCI\u002Fstent within 12 months, unstable angina, QTc \\>480 ms, or other clinically significant arrhythmia per investigator judgment.\n* History of CNS injury, seizure, stroke, or brain hemorrhage requiring treatment within 6 months.\n* Active viral infections:\n\n  * HIV antibody positive, syphilis serology positive;\n  * HBsAg \\>10⁶ IU\u002FmL;\n  * HCV antibody positive;\n  * EBV positive (EBER or copy number above normal).\n* Need for long-term systemic corticosteroid therapy during DIT-101 infusion (local or inhaled steroids allowed).\n* Active autoimmune disease requiring treatment, immunodeficiency, or use of immunosuppressive therapy.\n* Acute or moderate-to-severe chronic graft-versus-host disease (GvHD) within 4 weeks prior to screening.\n* Known severe allergy to any component of DIT-101.\n* Women of childbearing potential or men unable to use effective contraception during DIT-101 infusion and for 1 year post-infusion; plans for pregnancy within 1 year post-infusion in male or female subjects or their partners.\n* Any condition that, in the investigator's opinion, may increase risk or interfere with study outcomes.\n* Prior malignancy other than hematologic malignancy, except:\n\n  * Malignancy treated with curative intent and disease-free ≥2 years;\n  * Non-melanoma skin cancer adequately treated with no current evidence of disease.","70 Years",{"count":19,"type":20},[23],"This study is a single-arm, open-label clinical trial designed to evaluate the safety and tolerability of DIT101 in adults with relapsed or refractory hematologic malignancies and to explore its potential anti-tumor effects.\n\nDIT101 is an investigational in vivo CAR-T cell therapy administered by intravenous infusion. After administration, it is intended to generate CAR-T cells within the patient's body that can recognize and attack tumor cells. Unlike approved autologous CAR-T therapies, DIT101 does not require collection and ex vivo genetic modification of the participant's own cells.\n\nThe study includes a screening period, DIT101 infusion treatment, a post-treatment intensive follow-up period of approximately 6 months, and a long-term follow-up period of up to 2 years, with visits every 3-6 months.",[79],"Relapsed or Refractory Hematologic Malignancies","NOT_YET_RECRUITING","2026-03-16",{"date":83,"type":34},"2026-03-20",{"date":85,"type":20},"2026-04-15",{"date":87,"type":20},"2028-10-15",{"name":40,"class":41},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100610707","phase-1-phase-i-study-of-tx103-car-t-cells-in-participants-with-advanced-solid-tumors-100610707","NCT07231081","Phase I Study of TX103 CAR-T Cells in Participants With Advanced Solid Tumors","An Open-label, Single-arm, Phase I Clinical Trial to Evaluate the Safety and Efficacy of TX103 CAR-T Cells in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Voluntary participation: Subjects must voluntarily participate in this clinical trial, fully understand and sign the informed consent form (ICF), and be willing and able to comply with all study procedures.\n\n  2\\. Age: Male or female patients aged ≥18 years and \\\u003C75 years at the time of signing the ICF.\n\n  3\\. Diagnosis: Subjects must have B7-H3\u002FCD276-positive advanced solid tumors confirmed by pathology, who have failed standard therapy or are intolerant to standard treatment.\n  * Intraperitoneal infusion cohort: limited to subjects with recurrent or metastatic ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or other advanced solid tumors with peritoneal metastases confined to the peritoneal cavity.\n  * Intravenous infusion cohort: subjects with advanced solid tumors regardless of peritoneal metastasis, preferably including head and neck squamous cell carcinoma, esophageal cancer, lung malignancies, triple-negative breast cancer, colorectal cancer, and mesenchymal-derived malignancies.\n\n    4\\. B7-H3\u002FCD276 expression: Tumor tissue immunohistochemistry (IHC) results show B7-H3\u002FCD276 positivity ≥20%, defined as the percentage of viable tumor cells with positive membrane expression of B7-H3\u002FCD276 in non-necrotic tumor tissue.\n\n    5\\. Measurable\u002Fevaluable disease:\n  * Intraperitoneal infusion cohort, Phase Ia: at least one evaluable lesion per RECIST 1.1;\n  * Intravenous infusion cohorts (Ia and Ib) and intraperitoneal infusion cohort (Ib): at least one measurable lesion per RECIST 1.1.\n\n    6\\. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\n    7\\. Life expectancy: Expected survival of \\>6 months. 8. Apheresis capability: Adequate venous access for leukapheresis and no contraindications to the procedure.\n\n    9\\. Adequate organ function (per NCI CTCAE v5.0) within screening period:\n    1. Hematologic: WBC ≥ 3.0×10⁹\u002FL; hemoglobin ≥ 8.0 g\u002FdL; absolute neutrophil count ≥ 1.5×10⁹\u002FL; platelet count ≥ 75.0×10⁹\u002FL. No transfusions or supportive treatments (e.g., G-CSF, erythropoietin, TPO agonists, IL-11) within 14 days before testing.\n    2. Renal: Serum creatinine ≤ 1.5× upper limit of normal (ULN) and estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl, per Cockcroft-Gault formula) \\> 50 mL\u002Fmin.\n    3. Hepatic: ALT and AST ≤ 2.5× ULN (≤ 5.0× ULN for patients with liver metastases).\n    4. Bilirubin: Total bilirubin ≤ 2.0× ULN (except for patients with Gilbert's syndrome).\n    5. Coagulation: PT, APTT, or INR ≤ 1.5× ULN (without anticoagulant therapy).\n    6. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% within 1 month before enrollment.\n    7. Pregnancy test: Negative serum pregnancy test for women of childbearing potential.\n    8. Contraception: Subjects with reproductive potential must agree to use effective contraception from the date of informed consent signing until 365 days after the last infusion.\n\n       Exclusion Criteria:\n* 1\\. Pregnant or lactating women. 2. Viral infections:\n\n  1. Positive for HIV antibody or syphilis serologic test;\n  2. Positive for HBsAg or HBcAb with HBV DNA ≥ 2000 IU\u002FmL;\n  3. Positive for HCV antibody with detectable HCV RNA;\n  4. Presence of other active viremia. 3. Known hypersensitivity, allergy, intolerance, or contraindication to TX103 CAR-T or any component of the study drugs (including fludarabine, cyclophosphamide, or tocilizumab), or history of severe allergic reactions.\n\n     4\\. Active autoimmune diseases, including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.\n     * Subjects with vitiligo or childhood asthma that has resolved and requires no intervention may be included.\n     * Subjects requiring medical intervention for asthma (e.g., bronchodilators) are excluded.\n\n       5\\. Receiving systemic immunosuppressive therapy, or judged by the investigator to require long-term immunosuppressants during the study. Topical, inhaled, or intranasal corticosteroids are permitted.\n\n       6\\. Prior exposure to any gene-engineered T-cell therapy (including CAR-T or TCR-T) or any other gene therapy.\n\n       7\\. History of organ transplantation. 8. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal metastases.\n     * Subjects previously treated for brain\u002Fleptomeningeal metastases may be eligible if neurologically stable for ≥1 month (MRI) and off systemic corticosteroids for \\>2 weeks.\n\n       9\\. Imaging (CT\u002FMRI) showing tumor invasion of major blood vessels (e.g., aorta, pulmonary arteries\u002Fveins, vena cava) or indistinct vascular margins.\n\n       10\\. History of epilepsy or seizure-provoking disorders within 1 year prior to infusion.\n\n       11\\. Unresolved toxicities from prior anticancer therapy not recovered to CTCAE v5.0 Grade ≤1, except for investigator-judged non-safety-risk toxicities (e.g., alopecia, Grade 2 peripheral neuropathy, stable hypothyroidism with replacement therapy).\n\n       12\\. Major surgery or significant trauma within 1 month prior to leukapheresis. 13. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase risk or interfere with study results, including but not limited to:\n\n  \u003C!-- -->\n\n  1. Active infection requiring systemic therapy prior to lymphodepletion;\n  2. Uncontrolled cardiac disease: unstable angina, myocardial infarction within 1 year, heart failure (NYHA class ≥ II), or clinically significant arrhythmia requiring treatment\u002Fintervention;\n  3. Poorly controlled hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg despite therapy);\n  4. Clinically significant bleeding (e.g., GI bleeding, bleeding ulcers, stool occult blood ++ or above, vasculitis) within 3 months before first infusion;\n  5. Arterial\u002Fvenous thrombotic events (e.g., stroke, TIA, intracerebral hemorrhage, DVT, pulmonary embolism) within 6 months before first infusion;\n  6. Clinically significant pleural, pericardial, or peritoneal effusions not controllable by drainage or other means;\n  7. Severe cirrhosis, hepatic atrophy, or severe portal hypertension;\n  8. Complete intestinal obstruction. 14. History of or concurrent malignancy within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast).",{"count":97,"type":20},85,[23],"This is a single-arm, open-label, Phase I study to evaluate the safety, tolerability, and antitumor activity of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors. The study also aims to explore the maximum tolerated dose (MTD) and determine the recommended Phase II dose (RP2D) of TX103 CAR-T cell therapy.",[101],"Solid Tumors","2025-11-13",{"date":104,"type":34},"2025-11-17",{"date":106,"type":34},"2025-10-16",{"date":108,"type":20},"2027-12-20",{"name":40,"class":41},2,""]