[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Suzhou Immunofoco Biotechnology Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,58],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100630858","early-phase-1-a-study-of-imv102-in-patients-with-relapsedrefractory-multiple-myeloma-100630858",false,"NCT07493135","A Study of IMV102 in Patients With Relapsed\u002FRefractory Multiple Myeloma","A Single-Arm, Open-Label Early-Phase Clinical Study of IMV102 Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n1. Age: Aged 18 to 80 years (inclusive), of either sex.\n2. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n3. Diagnosed with relapsed\u002Frefractory multiple myeloma according to the IMWG criteria, who have received at least 3 prior lines of therapy (including a proteasome inhibitor and an immunomodulatory agent-based regimen).\n4. Reproductive Status: Subjects of childbearing potential and their partners must agree to use medically accepted highly effective contraceptive methods (e.g., intrauterine device, condom) from the time of signing the informed consent form until 12 months after the last dose. They must not donate germ cells, including sperm or oocytes, during this period.\n5. Informed Consent: Subjects must voluntarily sign and date a written informed consent form (ICF) indicating agreement to participate in this study.\n6. Compliance: Subjects must be willing and able to comply with the scheduled treatment plan, laboratory tests, follow-up, and other study requirements.\n\nExclusion Criteria:\n\n1. Pregnancy\u002FLactation: Women who are pregnant or breastfeeding.\n2. Other Malignancies: Subjects with a prior or concurrent other malignancy.\n3. Infectious Diseases: Positive for human immunodeficiency virus (HIV) antibody; active hepatitis B virus infection (HBV-DNA \\> 10³ IU\u002FmL); acute or chronic active hepatitis C (HCV antibody positive); positive syphilis antibody; cytomegalovirus (CMV) infection (IgM positive or DNA positive).\n4. Presence of clinically active uncontrolled infection based on assessment done by treating physicians.\n5. Effusions: Presence of uncontrolled pleural effusion, pericardial effusion, or ascites prior to enrollment.\n6. Allergies: History of other severe allergies such as anaphylactic shock; known severe allergic reaction to IMV102 or any of its components; known severe allergic reaction to tocilizumab.\n7. Psychiatric Disorders: Subjects with severe mental disorders.\n8. Transplant History: History of solid organ transplantation.\n9. Compliance: Subjects whom the investigator assesses as unable or unwilling to comply with the requirements of the study protocol.\n10. Other Conditions: Subjects with any other concurrent severe and\u002For uncontrolled medical conditions that, in the judgment of the investigator, make them unsuitable for participation in this study.","ALL","18 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed\u002Frefractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.\n\nTumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)\u002Frelapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.",[27],"Relapsed\u002FRefractory Multiple Myeloma","RECRUITING","2026-03-25",{"date":31,"type":32},"2026-03-30","ACTUAL",{"date":34,"type":21},"2026-03-31",{"date":36,"type":21},"2028-04-01",{"name":38,"class":39},"Suzhou Immunofoco Biotechnology Co., Ltd","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":52,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":40},"100621901","early-phase-1-a-phase-iiia-open-label-single-center-dose-escalation-and-dose-expansion-study-to-evaluate-the-safety-tolerability-and-preliminary-efficacy-of-imv101-as-a-single-agent-in-subjects-with-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100621901","NCT07376642","A Phase I\u002FIIa, Open-label, Single-center, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IMV101 as a Single Agent in Subjects With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Aged 18 years or older, any sex.\n2. Previously histologically or cytologically confirmed relapsed\u002Frefractory B-cell non-Hodgkin's lymphoma, including the following WHO-defined types: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and mantle cell lymphoma (MCL), among others.\n3. CD19 positivity confirmed by pathology or flow cytometry analysis (subjects with prior exposure to CD19-targeted therapies must undergo repeat biopsy prior to enrollment to reconfirm CD19-positive status).\n4. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma meeting at least one of the following criteria:\n\n   1. Disease progression after at least two prior lines of systemic therapy (including relapse, treatment failure, or disease progression), with documented prior exposure to both an anti-CD20 monoclonal antibody (unless CD20-negative) and an anthracycline-based chemotherapy regimen.\n   2. Relapsed disease following autologous hematopoietic stem cell transplantation; or relapse occurring ≥2 years after allogeneic hematopoietic stem cell transplantation, in the absence of ongoing immunosuppressive therapy.\n   3. Primary refractory disease, defined as stable disease or disease progression as best response after at least two cycles of initial anti-CD20-based immunochemotherapy.\n\n      5． According to the Lugano lymphoma response criteria (Cheson et al, 2014), at least one measurable lesion must be present, meeting one of the following conditions:\n\n   \u003C!-- -->\n\n   1. A nodal lesion with a long axis \\>15 mm (short axis may be used if measurable).\n   2. An extranodal lesion with both long and short axes \\>10 mm. Lesions previously irradiated will only be considered measurable if documented progression has occurred after radiation therapy.\n\n      6． Life expectancy ≥ 12 weeks. 7． ECOG performance status score of 0 or 1. 8． Subjects must have adequate organ and marrow function. Laboratory screening must meet all of the following criteria, with all values falling within the specified ranges without ongoing supportive care. If any laboratory result is outside these limits, one repeat test is permitted within one week. If the repeat result still does not meet the criteria, the subject fails screening and is ineligible for enrollment:\n\n   \u003C!-- -->\n\n   1. Hematological criteria (in the absence of intensive transfusion \\[≥2 times within 1 week\\], platelet administration, or growth factor support \\[with the exception of recombinant erythropoietin\\] within 7 days prior to testing).\n   2. Hepatic Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤2.5×ULN, and total bilirubin ≤2×ULN (except in subjects with Gilbert's syndrome); for those with documented hepatic involvement by lymphoma, ALT and AST must be \\\u003C5×ULN.\n   3. Renal Function: Serum creatinine ≤1.5×ULN; if serum creatinine exceeds this threshold, creatinine clearance must be \\>50 mL\u002Fmin (calculated using the Cockcroft-Gault formula). Urine protein dipstick must be ≤1+; if dipstick result is ≥2+, 24-hour urine protein quantification is required (acceptable if \\\u003C1 g\u002F24h).\n\n      9． All toxicities from prior anticancer therapy must have resolved to Grade 0-1 (per NCI CTCAE v5.0) or to a level meeting the study's inclusion\u002Fexclusion criteria. Exceptions include alopecia, vitiligo, and other toxicities considered by the investigator to pose no safety risk to the subject.\n\n      10．Reproductive Status: Females of childbearing potential or male subjects with female partners of childbearing potential must be willing to use highly effective medically approved contraception from the time of informed consent until 12 months after IMV101 administration. Acceptable methods include intrauterine devices or condoms (childbearing potential includes premenopausal women and women within 24 months of menopause).\n\n      11． Subjects must provide signed and dated written informed consent. 12．Subjects must demonstrate willingness and ability to comply with the prescribed treatment plan, laboratory tests, follow-up visits, and other study requirements.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Subjects with active central nervous system (CNS) involvement or intestinal parenchymal involvement by B-cell non-Hodgkin lymphoma.\n3. Presence of lymphoma cells in cerebrospinal fluid (CSF), brain metastases, or a history of CNS lymphoma, primary CNS lymphoma, or previously detected lymphoma cells in CSF or brain metastases.\n4. Subjects with lymphoma infiltration of the atria or ventricles.\n5. Subjects who have received or require any of the following treatments\u002Ftherapies:\n\n   1. Acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n   2. Requiring immunosuppressive treatment during the study period due to autoimmune diseases (including but not limited to Crohn's disease, rheumatoid arthritis, psoriasis, systemic lupus erythematosus, or asthma requiring bronchodilator intervention), immunodeficiency, or other medical conditions. Exceptions include type 1 diabetes; dermatological conditions not requiring systemic therapy (e.g., vitiligo, psoriasis); alopecia; hypothyroidism managed with hormone replacement therapy only; childhood asthma that has completely resolved with no intervention required in adulthood; or other conditions not expected to recur in the absence of an external trigger.\n   3. Received autologous stem cell transplantation (ASCT) within 12 weeks prior to enrollment, or any prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n   4. Administration of live attenuated vaccines within 4 weeks before the planned IMV101 administration or planned receipt of such vaccines during the 12-week study period.\n   5. Systemic corticosteroid use at a dose exceeding 15 mg\u002Fday prednisone equivalent for more than 3 days within 2 weeks prior to IMV101 administration, with the exception of inhaled corticosteroids.\n   6. Any comorbidities that, in the Investigator's judgment, are expected to require systemic corticosteroid therapy (except for physiological replacement therapy with ≤12 mg\u002Fm²\u002Fday hydrocortisone or equivalent) or other immunosuppressive agents (excluding topical therapy) within 12 weeks after IMV101 administration;\n   7. Participation in another interventional clinical trial with receipt of any investigational product within 1 month prior to the planned administration of the study drug.\n   8. Prior to IMV101 administration, subjects who have received any of the following antineoplastic therapies: chemotherapy, targeted therapy, biologic therapy, endocrine therapy, or immunotherapy, where the last dose was administered within 28 days or 5 half-lives (whichever is shorter) before the first IMV101 dose in this study; or have received traditional Chinese medicine with approved antineoplastic indications within 2 weeks prior to IMV101 administration.\n   9. Major surgery within 2 weeks prior to enrollment in this study, or planned surgery during the waiting period for IMV101 administration or within 12 weeks after treatment (excluding scheduled procedures under local anesthesia).\n6. Subjects with a history of concurrent or previous other malignancies are excluded, except for the following conditions:\n\n   1. Adequately treated basal cell or squamous cell carcinoma (requiring sufficient wound healing prior to enrollment);\n   2. Carcinoma in situ of the cervix or breast, treated with curative intent and without evidence of recurrence for at least 3 years prior to the study;\n   3. Primary tumor that has been completely resected and in complete remission for ≥5 years.\n7. Seropositivity for human immunodeficiency virus (HIV); active hepatitis B virus (HBV) infection (HBV-DNA \\>10³IU\u002FmL); acute or chronic active hepatitis C (anti-HCV positive); confirmed syphilis seropositivity; active Epstein-Barr virus (EBV) infection (IgM-positive); active cytomegalovirus (CMV) infection (IgM-positive); or SARS-CoV-2 infection confirmed by nucleic acid or antigen testing without documented resolution to negative within 7 days.\n8. Active or clinically uncontrolled severe infection; or subjects with bacterial, fungal, or viral infections requiring intravenous antibiotic therapy who, in the judgment of the Investigator, are unsuitable for study participation; or subjects on prophylactic antibiotic therapy who, in the judgment of the Investigator, may continue in the study.\n9. Uncontrolled pleural effusion, pericardial effusion, or ascites present prior to participation in this study.\n10. Oxygen saturation≤95% while on nasal cannula oxygen.\n11. Presence of other significant pulmonary diseases that may limit participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormalities in pulmonary function tests.\n12. Known history or current presence of hepatic encephalopathy requiring treatment; subjects with current or historical central nervous system disorders, including but not limited to seizures, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune disease involving the CNS.\n13. Poorly controlled hypertension as determined by the Investigator (defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite standardized antihypertensive therapy); or hypotension requiring vasopressors; or poorly controlled diabetes despite standard treatment (fasting blood glucose ≥10.2 mmol\u002FL).\n14. History of any of the following cardiac symptoms or diseases within 6 months prior to IMV101 administration:\n\n    1. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    2. Myocardial infarction within 1 year; or unstable angina; or history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); or use of a cardiac pacemaker;\n    3. QTc interval \\> 450 ms (male) or \\> 470 ms (female) on resting electrocardiogram (ECG)\n    4. Clinically significant abnormalities on resting ECG (e.g., abnormalities in heart rate, conduction, or morphology) or complete left bundle branch block, third-degree atrioventricular block, or PR interval \\> 250 ms.\n15. History of other severe allergic reactions, such as anaphylaxis.\n16. Subjects with severe psychiatric disorders.\n17. Subjects with newly developed arrhythmias, including but not limited to those not adequately controlled by antiarrhythmic medication.\n18. History of solid organ transplantation.\n19. Subjects who, in the opinion of the Investigator, are unable or unwilling to comply with the requirements of the study protocol.\n20. Presence of any other concurrent severe and\u002For uncontrolled medical condition that, based on the Investigator's judgment, renders the subject unsuitable for study participation.",{"count":20,"type":21},[24],"A phase I\u002FIIa, open-label, single-center, dose-escalation and dose-expansion study to evaluate the safety, tolerability, and preliminary efficacy of IMV101 as a single agent in subjects with relapsed\u002Frefractory B-cell non-Hodgkin Phase I:To observe and evaluate the safety and tolerability of IMV101 in subjects with relapsed\u002Frefractory B-cell non-Hodgkin lymphoma.\n\nPhase IIa:To determine the Recommended Phase II Dose (RP2D) based on integrated safety and efficacy data following IMV101 treatment.\n\nTo evaluate the preliminary antitumor efficacy of IMV101. Secondary Study Objectives:To evaluate other safety parameters following IMV101 treatment.\n\nTo evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiles following administration of IMV101.\n\nExploratory Objective:To evaluate biomarkers change pre- and post-IMV101 administration and their correlation with efficacy and safety.\n\nTo perform long-term follow-up for immunogenicity analysis, viral shedding studies, tumor multi-omics research, lentiviral integration sites, and replication-competent lentivirus (RCL), among others.",[51],"Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma",{"date":31,"type":32},{"date":54,"type":32},"2025-12-29",{"date":56,"type":21},"2027-12-31",{"name":38,"class":39},{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100600913","phase-3-a-phase-iii-randomized-study-in-cldn182-positive-unresectable-locally-advanced-gastric-cancer-patients-100600913","NCT07103668","A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients","An Open-label, Randomized, Comparative Phase III Study Including Patients With CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer.","Inclusion Criteria:\n\n1. The age at randomization was at least 18 years old , and both men and women were eligible.\n2. histologically or cytologically confirmed inoperable locally advanced or metastatic gastric\u002Fesophagogastric junction adenocarcinoma who have failed at least two prior lines of therapy :\n\n   1. Radiographic progression or clinical worsening of symptoms during second-line treatment (if first-line treatment includes three drugs including taxanes (or anthracyclines), platinums, and fluorouracils, and the disease progression is assessed by the investigator, the patient may also be enrolled as an eligible subject; disease progression within 6 months after the end of neoadjuvant\u002Fadjuvant treatment is also considered a first-line treatment failure);\n   2. Patients with intolerance to second-line treatment may also be enrolled in the study after full evaluation by the investigator. The definition of intolerance to previous treatment is as follows:\n\n   any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) hematologic toxicity that has not recovered to Grade 1 or pre-treatment levels after 14 days of best supportive care; any Grade ≥ 3 (according to NCI CTCAE v5.0 criteria) non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) that has not resolved after 14 days of best supportive care.\n3. Tumor tissue specimens (primary or metastatic, archived or newly collected) from subjects are expected to be available and tested by a central laboratory, indicating positive histological staining for CLDN18.2 (defined as a positive tumor cell rate ≥40% and a staining intensity ≥2+) . If the subject has previously received other CLDN18.2-targeted therapies, tumor tissue specimens collected after that treatment are required to retest and evaluate CLDN18.2 expression levels .\n4. The subject's expected survival period is ≥12 weeks.\n5. According to RECIST 1.1, there should be at least one stably measurable target lesion or evaluable lesion, and the longest diameter of the largest lesion (or the shortest diameter if it is a lymph node lesion) should be ≤5 cm .\n6. ECOG performance status score is 0-1.\n7. The subject must have adequate organ and bone marrow function. Laboratory screening must meet the following criteria. All laboratory test results should be within the stable ranges described below, and there should be no ongoing supportive treatment. If any laboratory test result is abnormal based on the following criteria , the test can be repeated within 1 week. If the test results still do not meet the following criteria , the patient has failed the screening.\n\n   1. Blood tests \\[no enhanced blood transfusion ( ≥ 2 times within 1 week), platelet transfusion, or cell growth factor (except recombinant erythropoietin) within 7 days before the examination\\]: neutrophil count ≥ 1.5×10 9 \u002FL; platelet count (PLT) ≥ 75×10 9 \u002FL; hemoglobin content (Hb) ≥ 8.0 g\u002FdL; lymphocyte (LYM) ≥ 0.5×10 9 \u002FL;\n   2. Liver function: alanine aminotransferase (ALT) ≤ 2.5×ULN, aspartate aminotransferase (AST) ≤ 2.5×ULN, serum total bilirubin (TB) ≤ 2×ULN; for patients with liver metastasis, AST and ALT \\\u003C 5×ULN;\n   3. Renal function: Serum creatinine ≤ 1.5 × ULN. If serum creatinine is \\> 1.5 × ULN, creatinine clearance \\> 50 mL\u002Fmin (based on the Cockcroft-Gault formula); qualitative urine protein ≤ 1+; if qualitative urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required (a 24-hour urine protein quantitative test \\\u003C 1 g is acceptable);\n   4. Amylase and lipase ≤ 1.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN. For patients with bone metastases, ALP \\\u003C 5 × ULN.\n8. All toxic reactions caused by previous anti-tumor therapy have been alleviated to Grade 0-1 (according to NCI CTCAE Version 5.0) or to a level acceptable to the inclusion\u002Fexclusion criteria. This excludes other toxicities such as alopecia and vitiligo that the investigator believes do not pose a safety risk to the subjects.\n9. Reproductive status: Female patients of childbearing age or male patients whose sexual partners are female patients of childbearing age are willing to take medically approved and highly effective contraceptive measures , such as intrauterine devices or condoms, from the time the informed consent is signed until 12 months after cell infusion (female patients of childbearing age include premenopausal women and women within 24 months of postmenopause).\n10. The subjects must sign and date the written informed consent form.\n11. Subjects must be willing and able to comply with the scheduled treatment regimen, laboratory tests, follow-up and other study requirements.\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women.\n2. Positive human immunodeficiency virus (HIV) antibody test; hepatitis B virus infection ( HBsAg positive and\u002For HBc antibody positive, and HBV-DNA positive ); acute or chronic active hepatitis C (HCV antibody positive and HCV-RNA positive ); positive syphilis antibody test; Epstein-Barr virus infection (IgM positive); cytomegalovirus (CMV) infection (IgM positive) ; human T- lymphotropic virus ( HTLV ) positive; positive for novel coronavirus (COVID-19) and not reverting to negative within 7 days . The above pathogen test results are subject to the central laboratory test results.\n3. Known HER2 expression is positive (defined as IHC 3+, or IHC 2+ and FISH+).\n4. Active or clinically poorly controlled serious infection.\n5. Patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment.\n6. Extensive or diffuse lung metastases or extensive or diffuse liver metastases or extensive or diffuse bone metastases .\n7. Blood oxygen saturation is ≤ 95% without oxygen inhalation.\n8. Other serious pulmonary diseases that may limit their participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormalities in pulmonary function tests.\n9. Patients with deep and large ulcers of the primary lesion, or recurrence of the anastomotic site with tumor infiltration of the entire layer, or tumor lesions infiltrating large blood vessels, who are judged by the researchers to be at high risk of bleeding or perforation, were included in the CT\u002FMRI or combined gastroscopy examinations.\n10. Patients with known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system diseases, such as epileptic seizures, cerebral ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system; patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence indicating that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, who are judged by the investigator to be unsuitable for inclusion.\n11. unstable heart disease that requires treatment or heart disease that cannot be controlled after treatment, or hypertension that is poorly controlled as determined by the researchers (defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg after standard antihypertensive drug treatment); or diabetes that is still poorly controlled after standard treatment (fasting blood glucose ≥ 10.2 mmol\u002FL).\n12. Any of the following cardiac clinical symptoms or diseases within 6 months before cell infusion:\n\n    1. Left ventricular ejection fraction (LVEF) \\\u003C 50%;\n    2. Myocardial infarction within 1 year; or unstable angina; or history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); use of pacemaker;\n    3. Resting electrocardiogram (ECG) with QTc F \\>450 ms (male) or QTc F \\>470 ms (female);\n    4. Resting electrocardiogram reveals clinically significant abnormalities (such as abnormalities in heart rate, conduction, or morphological characteristics), complete left bundle branch block, third- degree atrioventricular block, or a PR interval greater than 250 ms.\n13. Evidence of a significant coagulopathy or other significant bleeding risk, including:\n\n    1. clinically significant coagulation abnormalities;\n    2. A history of intracranial hemorrhage or spinal cord hemorrhage;\n    3. Patients whose tumor lesions invade large blood vessels and have a significant risk of bleeding;\n    4. Patients with current unstable or active ulcers or active gastrointestinal bleeding;\n    5. An embolic event occurred within 6 months before cell transfusion;\n    6. Clinically significant hemoptysis or significant bleeding in tumor lesions occurred within 1 month before cell transfusion;\n    7. Major trauma or major surgery within 1 month before enrollment;\n    8. The presence of any bleeding disorders, such as hemophilia, von Willebrand disease, etc.;\n    9. Use of anticoagulant therapy (except low molecular weight heparin) for therapeutic purposes within 2 weeks before cell transfusion;\n    10. Patients are currently receiving conventional anticoagulant therapy (such as warfarin or heparin). Patients require long-term antiplatelet therapy (aspirin ≥ 100 mg\u002Fday; clopidogrel ≥ 75 mg\u002Fday); dipyridamole, ticlopidine, or cilostazol.\n14. Receipt of systemic steroids equivalent to \\>15 mg\u002Fday of prednisone for more than 3 days within 2 weeks before apheresis, excluding inhaled steroids.\n15. Subjects requiring systemic treatment with corticosteroids or other immunosuppressive drugs during treatment. Subjects with any active autoimmune disease, or a history of autoimmune disease with expected recurrence (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and asthma requiring medical intervention with bronchodilators). Exceptions include: type 1 diabetes; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis); alopecia; hypothyroidism requiring only hormone replacement therapy; asthma that fully resolved in childhood and does not require any intervention in adulthood; or other subjects whose condition is not expected to relapse in the absence of external triggers.\n16. Patients with previous or concurrent malignancies, with the following exceptions:\n\n    1. Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound healing was required before study enrollment);\n    2. Carcinoma in situ of cervical or breast cancer who has undergone curative treatment and has no signs of recurrence for at least 3 years before the study;\n    3. The primary malignancy has been completely resected and remains in complete remission for ≥ 5 years.\n17. Subjects who have previously received other gene therapies, including but not limited to CAR-T therapy and TCR-T therapy .\n18. Received the following treatments or drugs before cell infusion: received chemotherapy, targeted therapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (except for treatments used in accordance with the protocol requirements before infusion, such as lymphoproliferative conditioning and bridging therapy) , less than 28 days or less than 5 half-lives (whichever is shorter) from the first infusion of treatment in this study ; received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before cell infusion.\n19. There is a history of other severe allergies such as anaphylactic shock.\n20. Subjects with severe mental disorders.\n21. If a subject develops a new arrhythmia, including but not limited to arrhythmias that cannot be controlled with medication; hypotension requiring pressor medication; or bacterial, fungal, or viral infection requiring intravenous antibiotics , the investigator may determine that the subject is unsuitable for participation in the trial . Subjects who are taking antibiotics to prevent infection may continue to participate in the trial at the investigator's discretion.\n22. Participation in other interventional clinical studies and use of study drug within 1 month before the planned IMC 002 infusion .\n23. The investigator assesses that the subject is unable or unwilling to comply with the requirements of the study protocol.\n24. 4 weeks before the planned apheresis time or plan to receive a live attenuated vaccine during the study.\n25. Subjects with gastrointestinal obstruction or obstructive jaundice are deemed unsuitable for participation in this trial by the investigator .\n26. Subjects with any other concurrent serious and\u002For uncontrolled medical conditions who are deemed unsuitable for participation in this trial by the investigator.",{"count":66,"type":21},150,[68],"PHASE3","An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer. To evaluate the objective response rate (ORR) and progression-free survival (PFS) of IMC002 compared with investigator's choice of treatment (ICT) as third-line or later therapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.",[71],"Gastric Adenocarcinoma","2025-10-21",{"date":74,"type":32},"2025-10-23",{"date":76,"type":32},"2025-08-06",{"date":78,"type":21},"2027-05-31",{"name":38,"class":39},1,""]