[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jecho Biopharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":155},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,43,67,94,114,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100639077","phase-1-a-phase-i-study-of-jlm019-injection-100639077",false,"NCT07623850","A Phase I Study of JLM019 Injection","A Phase I Study to Evaluate the Safety and Tolerability of JLM019 Injection in Patients With Advanced Malignancies","JLM019","Inclusion Criteria:\n\n1. Eighteen years of age or older;\n2. Patients with histopathologically or cytologically confirmed advanced solid tumors (AST) or relapsed\u002Frefractory (r\u002Fr) Hodgkin's\u002FNon-Hodgkin's lymphomas (HL\u002FNHL, including transformed lymphomas):\n\n   * AST subtypes include but are not limited: colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), gastric cancer (GC), ovarian cancer (OV), renal cell carcinoma (RCC), melanoma, biliary tract cancer (BTC), alveolar soft part sarcoma (ASPS), etc.\n   * HL\u002FNHL subtypes include but are not limited: classical Hodgkin lymphoma (cHL), diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), mantle cell lymphoma (MCL), etc.\n3. Measurable disease as defined as:\n\n   * AST: At least one tumor lesion ≥ 10 mm in the longest diameter as assessed by computed tomography (CT);\n   * HL\u002FNHL: Fluorodeoxyglucose (FDG) avid disease by positron emission tomography (PET) and ≥ 1 lesion \\> 15 mm in the longest diameter by \\> 10 mm in the short axis, as assessed by CT;\n4. Patients with the following molecular profiles will be prioritized for enrollment:\n\n   * High tumor T-cell infiltration (e.g., elevated T-cell GEP score);\n   * TMB \\> 10 mut\u002FMb、MSI-H\u002FdMMR status or POLE\u002FPOLD1 mutations. Absence of β2M and JAK1\u002FJAK2 loss-of-function mutations.\n5. Submission of tumor biopsy representative of the current disease, which may consist of any of the following:\n\n   * Archived formalin-fixed paraffin-embedded (FFPE) tissue block;\n   * At least 15-20 slides of tumor tissue from an FFPE block suitable for immunohistochemistry (IHC), including ≥ 10 % tumor content per section with ≥ 20 mm2 of evaluable tissue which may include ≤ 50 % tumor adjacent tissue;\n   * A fresh tumor biopsy obtained by surgical excision or core needle procedure prior to the first dose of JLM019 Injection;\n6. For patients with accessible tumors, willingness to undergo on-study biopsy as scheduled in the protocol;\n7. Eastern Cooperative Oncology Group (ECOG) performance status grade 0\\~1;\n8. Life expectancy ≥ 3 months estimated by the Investigator;\n9. Recovery to Grade ≤ 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to the first dose of investigational product (except alopecia, hearing loss, Grade ≤ 2 neuropathy, or endocrinopathy managed with replacement therapy);\n10. Adequate baseline hematologic, renal, hepatic, and cardiac function as defined by:\n\n    * Lymphocyte ≥ 0.5 × 109\u002FL；\n    * ANC ≥ 1.5 × 109\u002FL;\n    * Platelet count (PLT) ≥ 100 × 109\u002FL;\n    * Hemoglobin (HGB)≥ 90 g\u002FL (no packed red blood cell transfusion within the prior 2 weeks);\n    * Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN for patients with Gilbert's disease;\n    * Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73 m2, as calculated by the Modification of Diet in Renal Disease (MDRD) formula;\n    * ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if there is evidence of hepatic involvement by malignant disease);\n    * International normalized ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy in which PT or aPTT is within therapeutic range of intended use of anticoagulants;\n    * High sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro B-type natriuretic peptide (NT-proBNP) ≤ ULN (asymptomatic abnormalities may be permitted after clearance by cardiology consultation).\n11. All patients and their partners must have no plans for conception from screening period and during the trial, and agree to practice effective contraception during the trial and for 4 months after the last dose of JLM019.\n12. Able to participate and willing to give written informed consent form.\n\nExclusion Criteria:\n\n1. Allergy to JLM019 Injection components;\n2. History of Grade 4 infusion-related, anaphylactic or allergic reaction to any previous monoclonal antibody or other Fc-based protein therapy;\n3. Experienced any cardiovascular immune-related adverse event (irAE), or discontinued from that treatment due to a Grade 3 or higher irAE in previous ICI therapy;\n4. Any serious or uncontrolled health conditions listed below:\n\n   * Patients with concurrent infections requiring intravenous antimicrobial therapy within the past 2 weeks, or with unexplained fever (body temperature ≥ 37.5 °C);\n   * History of vascular diseases within the past 6 months (including myocardial infarction, unstable angina, cerebrovascular diseases, and peripheral arterial or aortic diseases);\n   * Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least two separate occasions after antihypertensive treatment);\n   * Individuals with active thrombosis, active bleeding, or pathological conditions associated with high bleeding risk (such as coagulation disorders);\n   * Has an active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;\n   * Any serious or uncontrolled cardiovascular condition, including but not necessarily limited to:\n\n     1. Any history of myocarditis of any etiology;\n     2. History of New York Heart Association Class III or IV congestive heart failure, myocardial infarction, unstable angina, cerebrovascular accident, cardiac hospitalization, or other acute uncontrolled heart disease within 6 months of scheduled C1D1;\n     3. Left ventricular ejection fraction \\\u003C 45 % on screening echocardiogram;\n     4. Any clinically significant findings on screening EKG such as atrial or ventricular arrythmia (other than sinus tachycardia) or AV conduction abnormality such as left bundle branch block (such patients may be enrolled after cardiology clearance and Sponsor approval);\n5. History of (non-infectious) pneumonitis \u002F interstitial lung disease or current pneumonitis \u002F interstitial lung disease;\n6. Presence of any active central nervous system (CNS; brain or leptomeningeal) metastases. Solid tumor patients with CNS metastases are eligible if previously treated and there is no magnetic resonance imaging (MRI) evidence of progression for ≥ 8 weeks after treatment is complete and within 28 days prior to first dose of JLM019 Injection;\n7. Prior organ allograft or allogeneic hematopoietic stem cell transplantation (HSCT). Lymphoma patients ≥ 3 months post-HSCT with no evidence of active graft versus host disease may be eligible upon approval by the Investigator or Sponsor;\n8. Receipt of any of the following within the timeframes indicated, before first scheduled dose of JLM019 Injection:\n\n   1. Checkpoint inhibitors, including PD-(L)1 (e.g., pembrolizumab, nivolumab, cemiplimab, avelumab, durvalumab), CTLA-4 (e.g., ipilimumab, tremelimumab) and Lag-3 (e.g., relatlimab), or costimulatory agonists (including but not limited to CD28, CD134 (OX40), CD137 (4-1BB)): 3 months (135 days for atezolizumab);\n   2. Chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks. Note: for lung cancers or mesotheliomas, radiation therapy to the lung that is \\> 30 Gy within 6 months;\n   3. Other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody-like drugs, cytokines, cell therapies, or radio immunoconjugates: 4 weeks (2 weeks permissible with documented disease progression and approval by the medical monitor or Sponsor);\n9. Currently participating in another clinical trial or has participated in another clinical trial within 4 weeks prior to the first dose of the investigational study treatment. Note: Patients who have entered the follow-up phase of another study may be enrolled if at least 4 weeks have elapsed since their last dose of study treatment;\n10. Any condition requiring systemic treatment with either corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive medications within 14 days of the first dose of JLM019 Injection. Inhaled, intranasal or topical corticosteroids or adrenal replacement doses of corticosteroids are permitted in the absence of active autoimmune disease;\n11. Received a live or live-attenuated vaccine within 30 days prior to the first dose of JLM019 Injection. Note: Administration of inactivated vaccines is allowed;\n12. Received radiotherapy within 2 weeks of start of study treatment or had a history of radiation pneumonitis. Note: Patients must have recovered from all radiation-related toxicities, not required corticosteroids, and show no evidence of radiation pneumonitis. A 1-week washout period is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease;\n13. Any second malignancy active within the previous 3 years( (except adequately treated carcinoma in situ of cervix, basal cell carcinoma or squamous cell skin carcinoma));\n14. Patients with a history of AIDS, syphilis, or active hepatitis \\[For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of quantification; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of quantification\\].\n15. Pregnancy or lactation, and a woman of childbearing potential (WOCBP) who has a positive pregnancy test (within 7 days) prior to treatment;\n16. Patients deemed unsuitable for participation in this study at the Investigator's discretion.","ALL","18 Years",{"count":20,"type":21},115,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a multicenter, single-arm, open-label, dose escalation phase (Part A) and dose expansion (Part B) study to evaluate the safety and tolerability of JLM019 Injection in patients with advanced malignancies.\n\nThe study subjects are adults with advanced malignancies including advanced solid tumors or relapsed\u002Frefractory lymphoma.\n\nDuring the dose escalation phase, the dose escalation scheme is the accelerated titration in 0.001 - 0.2 mg\u002Fkg cohorts plus a traditional '3 + 3' design in 0.6 - 10 mg\u002Fkg cohorts, jointly in nine dose cohorts 0.001, 0.01, 0.05, 0.2, 0.6, 1.5, 3, 6 and 10 mg\u002Fkg. JLM019 Injection is intended to be administered once a week (QW). However, the dose and interval of administration may be adjusted based on the acquired PK, PD, and safety data. Each treatment cycle is 28 days.The repeated dose is tentatively scheduled to be administered once weekly until one of the following occurs: disease progression, intolerable toxicity, requirement for new antitumor therapy, withdrawal of informed consent form, death, loss to follow-up, or other protocol-specified discontinuation conditions.\n\nSafety profile, DLT, MTD and RED of JLM019 Injection shall be assessed during and after treatment, with PK, PD, immunogenicity and Efficacy analyzed correspondingly.",[27,28,29],"Advanced Solid Tumor (Phase 1)","Hodgkin Lymphoma","Non-Hodgkin Lymphoma","RECRUITING","2026-05-28",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":34},"2026-01-13",{"date":38,"type":21},"2029-07-01",{"name":40,"class":41},"Jecho Biopharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100640781","phase-1-a-phase-i-study-of-jl19001-injection-alone-or-in-combination-with-standard-therapy-in-patients-with-advanced-solid-tumors-or-relapsedrefractory-b-cell-non-hodgkin-lymphoma-100640781","NCT07603479","A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Age and Gender: Aged ≥ 18 years at the time of signing the Informed Consent Form (ICF), regardless of gender.\n2. Disease Status: Patients with histologically or cytologically confirmed advanced solid tumors (AST) or relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (r\u002Fr B-NHL) who have failed standard therapy, have no available standard treatment options, are intolerant to, or refuse standard therapy. This includes, but is not limited to, melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (SCCHN), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone B-cell lymphoma (MZL). Specific requirements for each tumor type are as follows:\n\n   Melanoma: Advanced cutaneous or acral melanoma with progressive disease (PD) after ≥2 prior lines of systemic therapy. Prior treatment must include at least one immune checkpoint inhibitor (ICI; e.g., pembrolizumab, toripalimab, pucotenlimab, ipilimumab + nivolumab, atezolizumab) and at least one chemotherapy (e.g., dacarbazine, temozolomide, paclitaxel, nab-paclitaxel, cisplatin\u002Fcarboplatin, fotemustine). For patients with BRAF V600, NRAS, or KITmutations, prior treatment must include at least one targeted therapy against the specific mutation and one ICI (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   RCC: Metastatic or unresectable clear cell RCC with PD after ≥1 prior line of therapy or intolerance to ≥1 prior line. Prior treatment must include at least one targeted therapy (e.g., sunitinib, pazopanib, sorafenib, axitinib, lenvatinib, anlotinib, vorolanib + everolimus) and one ICI (e.g., toripalimab, pembrolizumab, benmelstobart, nivolumab, ipilimumab).\n\n   NSCLC: Stage IV NSCLC with PD after ≥2 prior lines of systemic therapy. For patients without driver alterations: Prior treatment must include at least one ICI (e.g., pembrolizumab, camrelizumab, tislelizumab, sintilimab, atezolizumab, sugemalimab, toripalimab, penpulimab, serplulimab, nivolumab + ipilimumab, ivonescimab) and\u002For platinum-based chemotherapy, plus one single-agent therapy (e.g., docetaxel, pemetrexed, gemcitabine, paclitaxel, vinorelbine, anlotinib).\n\n   For patients with driver alterations (e.g., EGFRmutations, ALKfusions, ROS1fusions, BRAF V600mutations, NTRKfusions, METexon 14 skipping, RETalterations, KRAS G12Cmutations, or HER2mutations): Prior treatment must include at least one targeted therapy against the specific alteration and one platinum-doublet chemotherapy or single-agent therapy (as listed above). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   SCCHN: Metastatic head and neck squamous cell carcinoma with PD after ≥2 prior lines of systemic therapy.\n\n   Non-nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and either an ICI (e.g., pembrolizumab, finotonlimab, toripalimab, nivolumab) or an EGFR monoclonal antibody (e.g., cetuximab).\n\n   Nasopharyngeal carcinoma: Prior treatment must include platinum-based chemotherapy and an ICI (e.g., camrelizumab, toripalimab, tislelizumab, penpulimab, tagitanlimab). Patients unsuitable for or intolerant to the aforementioned treatments are excluded.\n\n   r\u002Fr B-NHL: PD after ≥2 prior lines of systemic therapy. Prior treatment must include a regimen containing an approved CD20 antibody (e.g., rituximab, zuberitamab, ripertamab).\n\n   Note: The later-line treatment status for all patients will be determined by the Investigator.\n3. Measurable Disease: Presence of at least one evaluable tumor lesion according to RECIST 1.1 (solid tumors) or Lugano criteria (lymphoma). Note: Lesions previously irradiated are not considered target lesions unless there is documented progression within the irradiated field or persistence of the lesion \\>3 months after radiotherapy.\n4. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (refer to Appendix 1: ECOG Performance Status).\n5. Laboratory Parameters: Adequate organ function within 14 days prior to enrollment, defined as:\n\n   Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet Count (PLT) ≥ 100 × 10⁹\u002FL Hemoglobin (HGB) ≥ 90 g\u002FL Total Bilirubin ≤ 1.5 × Upper Limit of Normal (ULN) Aspartate Aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases or hepatocellular carcinoma) Serum Creatinine ≤ 1.5 × ULN, or Calculated Creatinine Clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula) Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN International Normalized Ratio (INR) ≤ 1.5 × ULN\n6. Life Expectancy: Expected survival ≥ 12 weeks.\n7. Contraception and Pregnancy:\n\n   Participants of childbearing potential and their partners must agree to use highly effective non-pharmacological contraceptive methods during the study and for at least 12 weeks after the last dose.\n\n   Female participants of childbearing potential who are not surgically sterile must have a negative serum β-human chorionic gonadotropin (β-HCG) test within 7 days prior to the first dose and must not be breastfeeding.\n8. Consent and Compliance: Ability to understand and voluntarily sign the ICF, and willingness to comply with scheduled visits as per protocol.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be ineligible for this study:\n\n1. Hypersensitivity: Known hypersensitivity to any component of the investigational product or to drugs of the same class.\n2. CNS Metastases:\n\n   Patients with active central nervous system (CNS) metastases and\u002For carcinomatous meningitis are excluded.\n\n   However, the following patients are allowed:\n\n   ① Asymptomatic brain metastasis: No progressive CNS symptoms attributed to brain metastases, not requiring corticosteroids or requiring ≤ 10 mg\u002Fday prednisone (or equivalent), and lesion size ≤ 1.5 cm. These patients require regular brain imaging as a disease assessment site.\n\n   ② Treated brain metastases: Stable brain metastases for at least 2 months (confirmed by two imaging assessments at least 4 weeks apart post-treatment), with no evidence of new or enlarging lesions, and discontinued steroids ≥ 3 days prior to the first dose. Stability must be established prior to the first dose.\n3. Cardiac Conditions: Any of the following cardiac conditions:\n\n   1. QTc interval \\> 450 ms (male) or \\> 470 ms (female).\n   2. New York Heart Association (NYHA) Class III or IV congestive heart failure.\n   3. Unstable angina, new-onset angina, or myocardial infarction within 6 months prior to screening.\n   4. Clinically significant arrhythmias, including but not limited to complete left bundle branch block, second-degree atrioventricular block, or PR interval \\> 250 ms.\n   5. Valvular heart disease ≥ Grade 2 (CTCAE).\n   6. Left ventricular ejection fraction (LVEF) \\\u003C 50% as measured by echocardiogram.\n   7. Uncontrolled hypertension (systolic BP \\> 160 mmHg or diastolic BP \\> 100 mmHg); orthostatic hypotension or drug-induced hypotension (systolic BP \\\u003C 90 mmHg or diastolic BP \\\u003C 60 mmHg).\n   8. Uncontrolled systemic disease despite regular treatment (e.g., diabetes).\n4. Prior Immune Toxicity: History of prior immunotherapy with ≥ Grade 3 immune-related adverse events (irAEs) or ≥ Grade 2 immune-mediated myocarditis.\n5. Coagulopathy: Hereditary bleeding diathesis or coagulopathy, or history of clinically significant bleeding disorders or arterial\u002Fvenous thromboembolism (e.g., cerebrovascular events, deep vein thrombosis, pulmonary embolism) within 6 months prior to the first dose.\n6. Autoimmune Disease: Active autoimmune diseases such as systemic lupus erythematosus, rheumatic diseases, Crohn's disease, ulcerative colitis, etc.\n7. GI Perforation\u002FFistula: History of gastrointestinal perforation\u002Ffistula or risk factors for perforation within 6 months prior to the first dose.\n8. GI Bleeding: Any ≥ Grade 3 gastrointestinal bleeding within 12 weeks prior to the first dose.\n9. Transplantation: Prior allogeneic hematopoietic stem cell transplantation or organ transplantation.\n10. Interstitial Lung Disease: History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or clinically significant active pneumonitis at screening (excluding radiation-induced fibrosis not requiring steroid treatment).\n11. Effusions: Uncontrollable pleural effusion, pericardial effusion, or ascites, in the judgment of the Investigator.\n12. Other Malignancies: History of any other active malignancy within 3 years prior to the first dose (except for curatively treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or cancers with a disease-free survival \\> 1 year after radical treatment).\n13. Surgery\u002FTrauma: Major surgical procedure (excluding core needle biopsy) or significant traumatic injury within 4 weeks prior to the first dose, or planned elective surgery during the study period.\n14. Prior Anticancer Therapy: Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose. Specific washout periods:Nitrosoureas or mitomycin C (within 6 weeks); oral fluoropyrimidines or small molecule targeted drugs (within 2 weeks); traditional Chinese medicine with anti-tumor indications (within 2 weeks).\n15. Toxicity Recovery: Failure to recover from prior anticancer therapy toxicities to ≤ Grade 1 (per CTCAE v6.0), except for toxicities deemed safe by the Investigator (e.g., alopecia, Grade 2 peripheral neuropathy, hypothyroidism stable on hormone replacement).\n16. IL-2\u002FIL-15 Agonists: Receipt of IL-2 or IL-15 agonist therapy within 4 weeks prior to the first dose.\n17. Immunomodulators: Receipt of immunomodulatory drugs (including but not limited to thymosin, interferon) within 2 weeks prior to the first dose.\n18. Corticosteroids\u002FImmunosuppressants: Receipt of systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapies within 2 weeks prior to the first dose. Exceptions:Use of topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; short-term prophylactic use (e.g., contrast allergy prevention).\n19. Tuberculosis: Active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis \\> 1 year ago without adequate standard treatment.\n20. Active Infection: Serious infection requiring intravenous antibiotics or hospitalization within 4 weeks prior to the first dose.\n21. Viral Infections: Active viral infections, including:\n\n    Active hepatitis B (HBsAg or HBcAb positive and HBV DNA \\> upper limit of normal).\n\n    Active hepatitis C (HCV antibody positive and HCV RNA \\> upper limit of normal).\n\n    Human Immunodeficiency Virus (HIV) infection. Syphilis infection. Note: Patients receiving prophylactic antiviral therapy (excluding interferon) are permitted.\n22. Vaccinations: Receipt of live or attenuated live vaccines within 4 weeks prior to the first dose or anticipated receipt during the study period.\n23. Other: Any other severe physical or psychiatric illness, laboratory abnormality, or other condition that, in the judgment of the Investigator, would increase the risk to the participant, interfere with study results, or make participation inappropriate.",{"count":50,"type":21},14,[24],"This is a Phase I, multicenter, single-arm, open-label clinical study designed to evaluate the safety and tolerability of JL19001 Injection as monotherapy (Phase Ia) or in combination with standard therapy (Phase Ib) in patients with AST and r\u002Fr B-NHL. Only the Phase Ia protocol design is registered at this time. A total of 6 dose cohorts are planned for Phase Ia, i.e., 1, 5, 10, 15, 20, and 25 μg\u002Fkg, with the administration route being subcutaneous injection. A traditional 3 + 3 dose escalation design will be used. The MTD and Recommended Maximum Add-on Dose (RMAD) for JL19001 Injection will be determined.",[54,55,56,57],"Malignancies","Solid Malignant Tumor","NHL (Non-Hodgkin Lymphoma)","Solid Tumor Cancer","NOT_YET_RECRUITING","2026-05-18",{"date":61,"type":34},"2026-05-22",{"date":63,"type":21},"2026-05",{"date":65,"type":21},"2030-05",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":42},"100638731","phase-1-a-study-to-evaluate-jl18008-in-subject-with-hiv-immunological-non-responders-100638731","NCT07579741","A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders","Evaluation of Pharmacokinetics, Pharmacodynamics, and Safety of JL18008 Injection in Healthy Adult Subjects \u002F HIV Immunological Non-Responders: A Randomized, Double-Blind, Placebo-Controlled Phase I\u002FII Clinical Study","JL18008","Inclusion Criteria:\n\n1. Age 18 to 65 years (inclusive), male or female.\n2. Body mass index (BMI) 18.0 to 32.0 kg\u002Fm² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.\n3. Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.\n\n   Maintained HIV-1 RNA below 50 copies\u002FmL for at least 36 months (the earliest test date more than 36 months before enrollment), including transient viral blips (single HIV-1 RNA measurement between 50 and 200 copies\u002FmL after excluding laboratory error). At least two HIV-1 RNA results \\\u003C50 copies\u002FmL must be available (one may be from screening).\n4. Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells\u002FμL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells\u002FμL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).\n5. Willing to use effective non-pharmacological contraception with partner from screening until 3 months after study completion, and no plan for sperm\u002Fegg donation during this period.\n6. Able to understand and provide written informed consent, and willing to comply with all protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Known allergy to the study drug or any of its excipients.\n2. Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.\n3. Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.\n4. History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).\n5. History of systemic infection (viral, bacterial, parasitic, or fungal) requiring systemic treatment and\u002For hospitalization, or other opportunistic infection, within 30 days before screening.\n6. Active tuberculosis lesion within 30 days before screening.\n7. Blood disorders associated with hypersplenism (e.g., thalassemia, hereditary spherocytosis, Gaucher's disease, autoimmune hemolytic anemia) or history of splenectomy.\n8. Chronic diarrhea.\n9. Severe cardiovascular disease within 6 months before screening, including myocardial infarction, unstable angina, congestive heart failure (NYHA class ≥II), or arrhythmia requiring medication.\n10. Uncontrolled hypertension, defined as resting systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg on at least two repeated measurements on different days despite antihypertensive treatment.\n11. Positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus antibody (HCV-Ab) with detectable HCV-RNA, or active syphilis.\n12. Any of the following laboratory abnormalities at screening: hemoglobin \\\u003C90 g\u002FL; neutrophil count \\\u003C1.5×10⁹\u002FL; platelet count \\\u003C100×10⁹\u002FL; serum creatinine \\>1.5× upper limit of normal (ULN); alanine aminotransferase \\>2.5×ULN; aspartate aminotransferase \\>2.5×ULN; alkaline phosphatase \\>2.5×ULN; total bilirubin \\>1.5×ULN; international normalized ratio \\>1.5; activated partial thromboplastin time \\>1.5×ULN.\n13. Diagnosis of cancer within the screening period.\n14. Severe neurological or psychiatric disease, or history of seizures.\n15. History of drug abuse within 3 months before screening, or positive urine drug screen (including morphine, methamphetamine, ketamine, MDMA, THC, cocaine), or history of alcohol abuse.\n16. Participation in another clinical trial with receipt of investigational drug within 3 months before screening.\n17. Vaccination within 6 weeks before screening, or plan to receive any vaccination within 1 year after enrollment.\n18. Pregnancy, positive pregnancy test, or breastfeeding.\n19. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical study.","65 Years",{"count":77,"type":21},30,[24,79],"PHASE2","The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs).\n\nBased on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg\u002Fkg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation\u002Ffollow-up period. The study drug will be administered by intramuscular injection.",[82],"HIV Infections",[82,84,85],"Ib","Immunological Non-Responders","2026-05-06",{"date":88,"type":34},"2026-05-12",{"date":90,"type":21},"2026-04-30",{"date":92,"type":21},"2027-09-28",{"name":40,"class":41},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":42},"100631505","phase-1-a-phase-ibii-clinical-trial-to-evaluate-the-safety-and-efficacy-of-jl15003-injection-in-patients-with-recurrent-glioblastoma-rgbm-100631505","NCT07501559","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)","Inclusion Criteria:\n\n* 1\\. Age \\>= 18 years of age;\n* 2\\. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( \\\u003C=3 cm on contrast-enhanced MRI prior to JL15003 administration);\n* 3\\. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;\n* 4\\. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent\u002Fadjuvant temozolomide);\n* 5\\. Tolerable to intratumoral\u002Fintracavitary Ommaya reservoir catheter implantation;\n* 6\\. Karnofsky Performance Status (KPS) \\>=70 and expected survival time \\>= 3 months;\n* 7\\. Patients should have received a boost immunization with trivalent inactivated poliovirus vaccine between 1 week to 6 months prior to administration of the study drug, with a neutralizing antibody titer \\>=1:8 prior to the administration;\n* 8\\. Able to undergo brain MRI with and without contrast;\n* 9\\. All subjects and their partners must have no plans for conception from screening until 90 days after the end of the observation period and must agree to use effective non-pharmacological contraceptive measures during the trial;\n* 10\\. Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;\n* 2\\. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;\n* 3\\. Patients with combined severe or active diseases are defined as follows:\n* (1) Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5 F\u002F37.5 C) for more than a week;\n* (2) Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;\n* (3) Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4);\n* (4) History of vascular diseases (including myocardial infarction, unstable angina pectoris, cerebrovascular disease, peripheral arterial disease, or aortic disease, etc.) within 6 months;\n* (5) Uncontrolled hypertension (defined as systolic blood pressure \\>= 160 mmHg or diastolic blood pressure \\>= 100 mmHg on at least 2 separate occasions, despite antihypertensive medication);\n* (6) Patients with active thrombosis, active bleeding, or pathological conditions posing a high risk of bleeding (e.g., coagulation disorders);\n* (7) Patients with active autoimmune disease requiring systemic immunomodulatory therapy within 3 months;\n* 4\\. Patients with known history of agammaglobulinemia;\n* 5\\. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; Subjects with diffuse subependymal disease;\n* 6\\. Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle; The tumor crosses the midline;\n* 7\\. Patients with a history of neurological complications due to poliovirus infection;\n* 8\\. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);\n* 9\\. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin;\n* 10\\. Patients who have received antitumor therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy, TTFields, or other investigational antitumor drugs) within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the previous drug (whichever is longer), and has not recovered from the toxicities (i.e., to \\\u003C= Grade 1 per CTCAE v5.0, except for alopecia; peripheral neuropathy up to Grade 2 is acceptable);\n* 11\\. Patients who have received radiation therapy within 12 weeks prior to the administration of the investigational drug, excluding those who have undergone radiation therapy for progressive diseases outside the radiation area;\n* 12\\. Patients on greater than 5 mg per day of dexamethasone or equivalent doses of other hormones (inhaled or localized use of hormones, in the absence of active autoimmune disease) within 2 weeks prior to the administration of the investigational drug;\n* 13\\. The laboratory tests meet the following standards:\n* (1) Hemoglobin \\\u003C90g\u002FL;\n* (2) Platelet count \\\u003C100×10\\^9\u002FL;\n* (3) Neutrophil count \\\u003C1.5×10\\^9\u002FL;\n* (4) Creatinine \\> 1.5 × upper limit of normal (ULN);\n* (5) Serum total bilirubin (TBIL) \\> 1.5×ULN;\n* (6) AST\u002FALT\\> 2.5×ULN;\n* (7) Prothrombin and Partial Thromboplastin Times \\>1.2×ULN;\n* 14\\. Subjects with positive syphilis antibody, or active hepatitis \\[For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of normal; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of normal\\];\n* 15\\. Subjects who have received any vaccination within 4 weeks prior to the administration of the study drug, with the exception of the inactivated poliovirus vaccine, non-live seasonal influenza vaccines, or inactivated COVID-19 vaccines, mRNA vaccines;\n* 16\\. Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment;\n* 17\\. Subjects who are unsuitable for participation in this study at the Investigator's discretion.",{"count":101,"type":21},40,[24,79],"The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).",[105],"Recurrent Glioblastoma Multiforme(GBM)","2026-03-24",{"date":108,"type":34},"2026-03-30",{"date":110,"type":21},"2026-04",{"date":112,"type":21},"2030-04",{"name":40,"class":41},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100630153","phase-1-a-phase-iii-study-of-jl19001-injection-alone-or-in-combination-with-bcg-in-subjects-with-high-risk-non-muscle-invasive-bladder-cancer-100630153","NCT07483970","A Phase I\u002FII Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer.","JL19001-NMIBC","Inclusion Criteria:\n\n1. Subjects should voluntarily sign the informed consent, and agree to comply with all protocol-specified procedures .\n2. Male or female patients ≥18 years of age at the time of signing the ICF.\n3. Life expectancy ≥ 2 years.\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n5. Previous pathological biopsy was diagnosed as high-risk NMIBC.\n6. Cystoscopy showed complete resection of the lesion or the residual lesion is only CIS within 6 weeks prior to initial administration; For T1 lesions, postoperative pathological results must show the presence of bladder muscle layer.\n7. After fully understanding the benefits, risks, and alternatives of radical cystectomy, the subject voluntarily chooses not to undergo the surgery; or the subject is deemed unsuitable for radical cystectomy by the researcher\n8. Subjects with fertility and their partner should use contraception during the study treatment period and within 12 weeks after the end of the study treatment period. Non-surgical sterilized female subjects of reproductive age must be negative for serum HCG within 7 days prior to initial administration and must be non-lactating.\n\nExclusion Criteria:\n\n* 1\\. Individuals who are allergic to any component of the investigational product.\n\n  2\\. Received surgical treatment or radiotherapy for bladder lesions within 2 weeks prior to initial administration\n\n  3\\. Any of the following clinical laboratory values During the screening period Hematology:absolute neutrophil count (ANC) \\\u003C 1.5 ×109\u002FL, platelets \\\u003C 100 × 109\u002FL, Hemoglobin\\\u003C90 g\u002FL(Within 14 days prior to screening, no whole blood transfusion, component blood transfusion, or drugs such as colony stimulating factors \\[For example: Granulocyte Colony-Stimulating Factor,Granulocyte-Macrophage Colony-Stimulating Factor,Erythropoietin,Thrombopoietin\\] have been administered.) renal function:Creatinine\\> 1.5×upper limit of normal(ULN)or Creatinine Clearance≥ 60mL\u002Fmin(Calculate according to the Cockcroft-Gault formula); liver function(No history of liver protection treatment within 7 days prior to screening examination):Aspartate Aminotransferase \\> 2.5 × ULN;Alanine Aminotransferase \\> 2.5 × ULN;Total Bilirubin \\> 1.5× ULN; ECG examination: QT interval corrected by Fridericia (QTcF) \\> 450ms for males, QTcF \\> 470ms for females; Coagulation function: Activated Partial Thromboplastin Time \\> 1.5 × ULN; International Normalized Ratio \\> 1.5 × ULN; Prothrombin Time \\> 1.5 × ULN;\n\n  4\\. History of or evidence of muscle-invasive, locally advanced, metastatic and\u002For extravesical bladder cancer (inclusive of the prostatic urethra).\n\n  5\\. There are contraindications to cystoscopy and\u002For urethroscopy, such as urethral stricture, urinary tract infection (UTI) (referring to symptomatic infection with positive urine culture), gross hematuria, and small bladder capacity, etc;\n\n  6\\. Bladder dysfunction during the screening period, such as severe urinary incontinence or overactive bladder (OAB); bladder perforation detected during the screening period through cystoscopy or imaging examination;\n\n  7\\. During the screening period, if upper urinary tract tumors are detected during an upper urinary tract examination, or tumors in the prostatic urethra are detected during cystoscopy, or other malignant tumors are found within 5 years of the first dose, with the exception of skin basal cell carcinoma, squamous cell carcinoma, and cervical carcinoma in situ that have achieved complete remission or been effectively controlled through treatment, as well as Stage I\u002FII cancers that have received adequate treatment, or stable prostate cancer that is under active monitoring in complete remission or well-managed through androgen therapy\n\n  8\\. Symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV heart failure, or other severe cardiac dysfunction, which the investigator deems clinically significant.\n\n  9\\. Severe\u002Funstable angina pectoris, or myocardial infarction within 6 months prior to study entry.\n\n  10\\. History or evidence of uncontrollable central nervous system disease.\n\n  11\\. Past medical history or examination suggests active tuberculosis within 1 year prior to initial administration;\n\n  12\\. Severely infected people who need to be controlled by antibiotics, antivirals or antifungals;\n\n  13\\. Have a history of immunodeficiency, including HIV seropositivity, other acquired or congenital immunodeficiency diseases.\n\n  14\\. The subject had received systemic glucocorticoid treatment within 2 weeks prior to the first administration of the test drug, except for the following situations: the hormone dose was ≤ 10mg\u002Fday in prednisone equivalent; local, inhaled, or intranasal use of glucocorticoids; and subjects with contrast medium allergy received prophylactic one-time use of glucocorticoids before undergoing imaging enhancement examination;\n\n  15\\. History of active autoimmune disease;\n\n  16\\. Active hepatitis B (HBe-Ag positive and HBV DNA\\>=500 IU\u002FmL), hepatitis C (HCV antibody positive and HCV RNA higher than the lower limit of assay detection)\n\n  17\\. Received any other anti-tumor treatments within 4 weeks prior to the first dose, including systemic chemotherapy, small molecule targeted therapy, radiotherapy, and Chinese herbal medicine with anti-tumor effects, except for immediate bladder instillation chemotherapy performed after TURBT ≥ 14 days before dosing; Received immune checkpoint inhibitor therapy and antibody therapy within 6 months prior to the first dose;\n\n  18\\. The study is undergoing treatment in other clinical trials or has ended until less than 4 weeks after the first administration of the study;\n\n  19\\. The presence of other serious physical or mental illness, abnormal laboratory tests, and other factors that may increase the risk of participating in the study or interfere with the study results; And any other conditions that the investigator deems inappropriate for participation in this study.",{"count":122,"type":21},18,[24],"Phase Ia, an open-label, sequential, dose escalation study to evaluate the tolerability and safety of JL19001 Injection alone in subjects with high risk NMIBC. The investigators plan to test 3 dose levels, 100, 200, and 400 μg in the Phase Ia study. A traditional 3 + 3 dose escalation design will be used. Eligible subjects will be sequentially enrolled and will be observed for DLT(s) during the DLT monitoring period (Day 1 \\~ 21).",[126],"High Risk Non-muscle Invasive Bladder Cancer","2026-03-16",{"date":129,"type":34},"2026-03-19",{"date":108,"type":21},{"date":132,"type":21},"2028-03-30",{"name":40,"class":41},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100627022","phase-1-recombinant-human-interleukin-7-jl18008-for-the-treatment-of-hiv-infected-immunological-non-responders-100627022","NCT07443228","Recombinant Human Interleukin-7 (JL18008) for the Treatment of HIV-Infected Immunological Non-Responders","A Phase I\u002FII Study Evaluating the Safety, Tolerability, and Efficacy of JL18008 Injection in HIV-Infected Immunological Non-Responders","Inclusion Criteria:\n\n1. Age between 18 - 65 years old, male or female.\n2. Body Mass Index (BMI) between 18 - 32 kg\u002Fm2, body weight ≥ 50 kg in male and ≥ 45 kg in female.\n3. On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry.\n4. Plasma HIV RNA \\\u003C 50 copies\u002FmL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are \\\u003C 50 copies\u002FmL).\n5. During 12 months prior to study entry, CD4+ T cell counts \\> 100 and ≤ 350 cells\u002FµL measured in at least two measurements (including the screening measurement) and the interval between the two measurements should be ≥ 3 months (Note: only one time value of CD4+ T cell count \\> 350 during this period will be allowed to participate if the previous and subsequent CD4+ T cell count is in the range of \\> 100 and ≤ 350 cells\u002FµL).\n6. All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject\u002Fpartner must practice at least one form of barrier birth control (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, other barrier contraception, etc.), during study and 3 months after the study.\n7. The subject fully understands the requirements of the study and voluntarily signs the ICF.\n\nExclusion Criteria:\n\n1. Prior treatment with IL-7 or IL-2.\n2. Allergy to JL18008 Injection components, e.g. HSA.\n3. Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry.\n4. Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases.\n5. Any history of virus, bacteria, parasites or fungal infection and other opportunistic infections requiring systemic treatment and\u002For hospitalization within 30 days prior to study entry.\n6. Active tuberculosis within 30 days prior to study entry.\n7. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia.\n8. History of splenectomy.\n9. Any gastrointestinal illness associated with chronic or intermittent diarrhea.\n10. Severe cardiovascular disease: myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association \\> class II) or cardiac arrhythmia requiring medication within 6 months prior to study entry.\n11. Hypertension with a resting systolic blood pressure \\> 140 mmHg or a resting diastolic blood pressure \\> 90 mmHg despite adequate antihypertensive treatment.\n12. Hepatitis B Surface Antigen (HBs Ag) positive and\u002For Hepatitis C virus (HCV) antibody positive and HCV-RNA positive.\n13. Abnormal clinical laboratory tests results meet any of the following criteria: Hemoglobin (HGB) \\\u003C 120 g\u002FL for men and \\\u003C 110 g\u002FL for women; White blood cell (WBC) count \\\u003C 3.5 × 109\u002FL; neutrophil count (NEUT) \\\u003C 1.5 × 109\u002FL; Platelet (PLT) count \\\u003C 125 × 109\u002FL; Creatinine (Cr) \\> 1.1 × upper limit of normal value (ULN); Alanine aminotransferase (ALT) \\> 1.1 × ULN; Aspartate aminotransferase (AST) \\> 1.1 × ULN; Alkaline phosphatase (ALP) \\> 1.1 × ULN; Total bilirubin (TBIL) \\>1.1 × ULN; Phosphate level \\\u003C 2.5 mg\u002FdL; International normalized ratio (INR) \\> 1.3; Activated partial thromboplastin time (APTT) \\\u003C 1.5 × ULN.\n14. Any history of HIV related encephalopathy.\n15. Diagnosis of cancer within the last 5 years prior to study entry (except skin basal cell or squamous cell carrcinomas, and cutaneous Kaposi's sarcoma not requiring systemic therapy).\n16. Any history of severe mental disorders or epilepsy.\n17. History of drug abuse (e.g. heroin, cocaine, and crystal meth, etc.) or alcohol abuse (defined as the daily regular consumption of alcohol exceeding the following standard amount: 570 ml of beer, 750 ml of light beer, 200 ml of red wine or 60 ml of liquor, each containing about 20 g of alcohol) within 3 months prior to study entry and heavy smoker (over 20 cigarettes per day for more than 3 months) within 6 months prior to study entry.\n18. Treatment with another study drug within 3 months prior to study entry.\n19. History of vaccination with live attenuated vaccine in 6 weeks prior to study entry or vaccination planed during the study and within 3 months after completion of the study.\n20. Pregnancy or lactation.\n21. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":142,"type":21},52,[24],"JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and determine the RED in HIV INRs.\n\nPhase Ib: A randomized, double-blind, placebo-controlled, dose expansion study to evaluate the safety of JL18008 Injection and determine the RP2D in HIV INRs.\n\nPhase II: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JL18008 Injection in HIV INRs.",[146],"HIV","2026-02-24",{"date":149,"type":34},"2026-03-02",{"date":151,"type":21},"2026-05-30",{"date":153,"type":21},"2030-12-31",{"name":40,"class":41},""]