[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prostate-cancer-castration-resistant-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prostate-cancer-castration-resistant-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,77],{"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":25,"conditions":26,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100604110","phase-1-phase-12-dose-finding-safety-and-pk-study-in-advanced-refractory-solid-tumors-100604110",false,"NCT07145255","Phase 1\u002F2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors","A Multicenter, Open-label Phase 1\u002F2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors","Inclusion Criteria: Patients are eligible to be included in the study only if all of the following criteria apply:\n\n1. Provide written consent on an informed consent form (ICF), approved by an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.\n2. 18 years of age or older at the time of informed consent.\n3. Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or patients of childbearing potential under the following conditions:\n\n   * Must be nonlactating and have a negative serum (preferred) or urine pregnancy test results within 72 hours prior to the first dose of MBRC-201.\n   * Must agree not to try to become pregnant during the study and for at least 6 months after the final dose of MBRC-201\n   * Must agree to practice effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug.\n4. Male patients whose partners are of childbearing potential must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) (Section 10.4) for the duration of study participation and for 6 months after the final dose of study drug.\n5. Have a histologic or cytologic diagnosis of malignant solid tumor for which there are no standard-of-care treatment options known to confer a clinical benefit or for which the patient is ineligible or declines (except for Phase 1b-Cohort A).\n\n   A. For Phase 1a dose escalation: Patients must have one of the following tumor types:\n\n   i. mCRPC, breast cancer (TNBC, HR+\u002FHER2-negative or HER2-low, HR-\u002FHER2+), CRC, NSCLC, or PDAC\n\n   B. For Phase 1b: Patients must have one of the following tumor types:\n\n   i. Cohort A: Histologic or cytologic diagnosis of mCRPC (with confirmed adenocarcinoma histology) refractory to standard treatment.\n\n   Patients must have had prior exposure to at least one novel AR-targeted therapy (e.g., abiraterone acetate, enzalutamide, apalutamide, darolutamide). Prior taxane or lutetium Lu 177 vipivotide tetraxetan is acceptable but not required.\n\n   ii. Cohort B: Histologic or cytologic diagnosis of advanced metastatic NSCLC refractory to standard treatment.\n\n   iii. Cohort C: Histologic or cytologic diagnosis of advanced metastatic breast cancer (TNBC, HR+\u002FHER2-negative or HER2-low, HR-\u002FHER2+) refractory to standard treatment.\n\n   iv. Cohort D: Histologic or cytologic diagnosis of advanced metastatic CRC, PDAC refractory to standard treatment. The Sponsor may add or remove specific tumor indications based on emerging, real-time study results.\n6. Availability of a tumor tissue sample (formalin-fixed paraffin-embedded \\[FFPE\\]) must be confirmed if feasible. Patients without tumor sample may be eligible with medical monitor approval. Tumor biopsies are not required and should not be performed to assess eligibility.\n7. For Dose Escalation (Phase 1a), patients may have evaluable disease or measurable disease according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. For both Dose Expansion (Phase 1b) and Phase 2, patients must have measurable disease according to RECIST v1.1\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n9. Life expectancy ≥ 3 months\n10. Patient must have adequate organ and marrow function as defined below.\n\n    * Absolute neutrophil count (ANC) ≥ 1500\u002FuL\n    * Hemoglobin (Hgb) ≥ 9 g\u002FdL\n    * Platelet count ≥ 100,000\u002FuL\n    * International normalized ratio (INR) \\\u003C 1.5 (or ≤ 3.0 if on therapeutic anticoagulation)\n    * Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin by the CKD-EPI or similar equation or as measured by 24-hour urine collection\n    * Total bilirubin ≤ 1.5 × ULN \\[or ≤ 3-times ULN for patients with Gilbert's disease or documented hepatic tumor involvement\\]\n    * ALT and AST ≤ 3 × ULN \\[or ≤ 5-times ULN for patients with documented hepatic tumor involvement\\]\n\nExclusion Criteria: Patients are excluded from the study if any of the following criteria apply:\n\n1. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Allowed exceptions are patients with:\n\n   1. Non-melanoma skin cancer considered completely cured;\n   2. Localized prostate cancer treated with curative intent with no evidence of progression;\n   3. Low-risk or very low-risk (per standard clinical guidelines) localized prostate cancer under active surveillance without immediate intent to treat;\n   4. Malignancy that is otherwise considered cured with minimal risk of recurrence.\n2. Known or suspected sensitivity to any of the ingredients of the investigational product MBRC-201.\n3. Active cerebral\u002Fmeningeal disease related to the underlying malignancy. Patients with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior central nervous system disease has been treated and the patient is clinically stable. (defined as not having received steroid treatment for symptoms related to cerebral\u002Fmeningeal disease for at least 2 weeks prior to the first dose of study drug and with no ongoing related AEs).\n4. Any uncontrolled viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug, unless deemed not clinically significant by the investigator (e.g., onychomycosis). Routine antimicrobial prophylaxis is permitted.\n5. Active or symptomatic viral hepatitis, including patients with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients who have been treated for hepatitis C infection or who have spontaneously recovered are permitted.\n6. Patients with HIV infection with 1 or more of the following:\n\n   * Acquired immunodeficiency syndrome (AIDs)-defining opportunistic infection within 6 months of the start of screening\n   * A change in antiretroviral therapy within 3 months of the start of screening and viral load \\> 500 copies\u002FmL\n   * Receiving antiretroviral therapy that may interfere with study drug\n   * CD4 count \\\u003C 350 at screening\n7. Thromboembolic events and\u002For bleeding disorders ≤ 14 days (e.g., venous thromboembolism \\[VTE\\] or pulmonary embolism \\[or PE\\]) prior to the first dose of study drug\n8. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study drug\n9. A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) \\> 470 msec or patients with risk factors for Torsades de pointes\n10. Uncontrolled Inflammatory Bowel Disease (IBD)\n11. A history of (non-infectious) ILD\u002Fpneumonitis requiring steroid therapy, or active ILD\u002Fpneumonitis, or clinically suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n12. Uncontrolled autoimmune disease or syndrome\n13. Active ocular surface disease at screening, including confluent superficial keratitis, cornea epithelial defect, corneal ulcer or stromal opacity or any components of the ophthalmologic history which, in the investigator's opinion, may place the patient at significant risk. Cataracts alone are not an exclusion criterion.\n14. Any anticancer therapy within 14 days prior to the first dose of study drug, including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy, or any other agents to treat cancer (anti-hormonal therapy given for advanced prostate cancer or as adjuvant therapy for early stage, HR positive breast cancer is not considered cancer therapy for the purpose of this protocol).\n15. Use of any investigational drug within 14 days prior to the first dose of study drug.\n16. For Phase 1b and Phase 2: prior treatment with an ADC with a camptothecin (CPT) payload, such as Enhertu (trastuzumab deruxtecan), Datroway (datopotamab deruxtecan), or Trodelvy (sacituzumab govitecan). Prior treatment with irinotecan and other non-ADC topoisomerase inhibitors is allowed in all phases of the study.\n17. Current use of any prohibited concomitant medication(s).\n18. Major surgery within 28 days prior to first dose of study drug.\n19. Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n20. Any medical, psychiatric, addictive, or other kind of disorder which compromises the ability of the patient to give written informed consent and\u002For to comply with procedures.\n21. Condition or situation which, based on Investigator or Sponsor assessment, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study.\n22. Other serious underlying medical condition that would impair the patient's ability to receive or tolerate the planned treatment and follow-up","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.",[27,28,29,30,31],"Prostate Cancer Castration-resistant Prostate Cancer","Breast Cancer","Colo-rectal Cancer","Lung Cancer (Non-Small Cell)","Pancreas Cancer, Duct Cell Adenocarcinoma",[33,34,35,36,37,38],"ADC","prostate cancer","breast cancer","colorectal cancer","non-small cell lung cancer","MBrace","RECRUITING","2026-02-15",{"date":42,"type":43},"2026-02-17","ACTUAL",{"date":45,"type":43},"2025-09-03",{"date":47,"type":20},"2029-12-30",{"name":49,"class":50},"MBrace Therapeutics","INDUSTRY",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100615871","early-phase-1-an-exploratory-clinical-study-evaluating-the-safety-and-efficacy-of-allogeneic-car-nk-cell-therapy-for-metastatic-castration-resistant-prostate-cancer-mcrpc-100615871","NCT07298239","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy for Metastatic Castration-resistant Prostate Cancer (mCRPC)","A Single-Center, Open-Label, Single-Arm, Exploratory Clinical Study to Evaluate the Safety and Efficacy of Allogeneic CAR-NK Cell Therapy in Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n* Age ≥ 18 years, male;\n* Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) meeting the following criteria: ① Serum testosterone at castration level: \\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL; ② Meeting any one of the following conditions: a. PSA progression: Three consecutive rises in PSA measured at intervals of at least 1 week, with two increases being ≥ 50% above the PSA nadir, and a PSA value \\> 2 ng\u002FmL; b. Radiographic progression: Two or more new lesions detected on bone scan, or an increase in soft tissue lesions assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).\n* Expected survival ≥ 6 months;\n* ECOG performance status of 0-2;\n* Positive prostate-specific membrane antigen (PSMA) expression;\n* Voluntarily participate, provide written informed consent, and be able to comply with follow-up.\n\nExclusion Criteria:\n\n* Prior treatment with other cell therapy products besides the investigational product, such as dendritic cells (DC), cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;\n* History of other malignancies within 5 years prior to screening (except for completely resolved carcinoma in situ or malignancies deemed by the investigator to be slow-progressing);\n* Abnormal function of major organs: a. Absolute neutrophil count (ANC) \\\u003C 1.5 × 10⁹\u002FL; Platelet count (Plt) \\\u003C 100 × 10⁹\u002FL; Hemoglobin (Hb) \\\u003C 9 g\u002FdL; b. Liver function: Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≥ 2.5 × the upper limit of normal (ULN) (or ≥ 5 × ULN for subjects with liver metastases); c. Renal function: Serum creatinine (Cr) ≥ 1.5 × ULN; d. Coagulation function: Prothrombin time (PT), Activated partial thromboplastin time (APTT), International Normalized Ratio (INR) ≥ 1.5 × ULN;\n* Any currently treated active (viral, bacterial, fungal) infection, or any infection within the past 6 weeks requiring intravenous antibiotics for 7 days or longer, or any active infection requiring oral antibiotics within the past week;\n* Active autoimmune disease, or history of severe autoimmune disease requiring long-term immunosuppressive therapy;\n* Participation in another clinical trial study within 3 months;\n* Inability to employ effective contraceptive measures;\n* History of hypersensitivity to biologic macromolecular drugs;\n* Untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA ≥ 1000 copies\u002FmL, or patients with active hepatitis C;\n* Subjects deemed by the investigator to be unsuitable for participation in this study for other reasons.","MALE",{"count":61,"type":20},15,[63],"EARLY_PHASE1","This study introduces a new treatment approach for metastatic castration-resistant prostate cancer, a stage of disease that remains difficult to manage with current therapies. Prostate cancer is the second most common cancer in men worldwide, and many patients eventually progress to an advanced, treatment-resistant stage despite hormone therapy, newer hormonal agents, or chemotherapy. Patients with metastatic castration-resistant disease often face a poor prognosis, complications such as bone metastases, and significant impacts on quality of life, highlighting the urgent need for new treatment options. This research focuses on an innovative immunotherapy using allogeneic anti-PSMA CAR-NK cells, which are engineered natural killer cells designed to precisely recognize and kill prostate cancer cells expressing the prostate-specific membrane antigen. CAR-NK cells combine the natural tumor-killing ability of NK cells with enhanced targeting and reduced immune escape, offering a potentially safer and more effective strategy. Through this clinical study, the safety, tolerability, and preliminary effectiveness of anti-PSMA CAR-NK cell therapy will be evaluated, aiming to provide new evidence and expand future treatment possibilities for patients with advanced prostate cancer.",[27],"2026-01-21",{"date":68,"type":43},"2026-01-22",{"date":70,"type":43},"2025-12-18",{"date":72,"type":20},"2028-04-01",{"name":74,"class":75},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":59,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":76},"100604940","early-phase-1-study-of-allogeneic-anti-psma-car-nk-cell-for-metastatic-castration-resistant-prostate-cancer-100604940","NCT07156045","Study of Allogeneic Anti-PSMA CAR-NK Cell for Metastatic Castration-Resistant Prostate Cancer","Clinical Study on the Safety and Efficacy of Anti-PSMA CAR NK Cells in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\nTo enter the trial, subjects had to meet all of the following eligibility criteria:\n\n1. diagnosed metastatic castration-resistant prostate cancer (mCRPC);\n2. Castration level of serum testosterone (\\\u003C 50 ng\u002FdL or \\\u003C 1.7 nmol\u002FL);\n3. Positive expression of PSMA;\n4. According to the definition of CRPC in the Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 edition), the disease still progresses after castration and meets any of the following criteria:\n\n   A.According to the increase in PSA level, there should be 3 consecutive increases in PSA at least 1 week apart (the increase in PSA is more than 50% of the minimum value, and PSA \\> 2 ng\u002FmL); B.Progression of bone disease as defined by PCWG3, defined as the presence of 2 or more new lesions on bone scan; C.CT or MRI results suggested measurable metastasis (lymph node short diameter \\> 15 mm was defined as lymph node metastasis as assessed by RECIST 1.1);\n5. Expected survival time ≥6 months;\n6. Toxicity of any previous treatment had recovered to ≤ grade 1 at the time of enrollment (except hair loss and hearing loss);\n7. ECOG score of patients 0-2;\n8. Patients voluntarily participated and signed the informed consent, and followed the trial treatment plan and visit plan.\n\nExclusion Criteria:\n\nSubjects who meet one of the following conditions will not be enrolled in the trial:\n\n1. Previous recipients of other cell therapy products, such as dendritic cells (DC), multiple cytokine-induced killer cells (CIK), T cells, natural killer cells (NK), chimeric antigen receptor T-cell immunotherapy (CAR-T), etc.;\n2. Patients with a history of biological macromolecule drug allergy;\n3. Abnormal function of major organs:\n\n   A. Neutrophil count (ANC) \\\u003C 1.5×109\u002FL; Platelet count (Plt) \\\u003C 100×109\u002FL; Hemoglobin (Hb) \\\u003C 9 g\u002FdL; B. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN (≥5×ULN for liver metastases); C. Renal function: serum creatinine (Cr) ≥1.5×ULN; D. Prothrombin time (PT) \\> 15 s, activated partial thrombin time (APTT) was prolonged or shortened by more than 10 s (normal reference value 23 s-37 s), or international normalized ratio (INR) \\> 1.7; E. Pulmonary function: Severe respiratory diseases (active pulmonary tuberculosis, chronic obstructive pulmonary disease, interstitial lung disease, etc.)\n4. Previous treatment with any PSMA-targeted therapy;\n5. active autoimmune diseases (including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis) or need long-term immunosuppressive therapy of severe autoimmune disease (screening clinic within six weeks before any immunosuppressive therapy), or by the researchers determine in 3 months will be recurrence of subjects;\n6. have had other malignancies other than prostate cancer (other than basal or squamous cell skin cancer) in the past 5 years that are currently clinically significant and require intervention;\n7. Any active (viral, bacterial, fungal) infection currently being treated or any infection requiring intravenous antibiotics for 7 or more days or intervals during the past 6 weeks or any active infection requiring oral antibiotics during the past 1 week;\n8. untreated chronic active hepatitis B, or chronic hepatitis B virus carriers with HBV DNA≥1000 copies \u002FmL, or active hepatitis C patients;\n9. Patients who have participated in other clinical trials and used study drugs within 3 months;\n10. Effective contraceptive measures cannot be adopted ;\n11. In the opinion of the investigator, there are other factors that are not suitable for inclusion or affect the participant's participation or completion of the study.",{"count":85,"type":20},10,[63],"At present, no cell drug with an indication for mCRPC has been approved for marketing in China, and there is no scholar to fight against it PSMA-CAR-NK cell therapy CRPC was reported in a study. Based on the previous basic research, our company has developed CAR-NK cell injection, hoping to further evaluate its safety, tolerability and preliminary efficacy in the treatment of mCRPC patients in clinical studies, and provide new possibilities for the selection of clinical treatment strategies",[27],{"date":90,"type":43},"2026-01-23",{"date":92,"type":43},"2025-09-01",{"date":94,"type":20},"2026-12-31",{"name":74,"class":75}]