[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai AbelZeta Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":135},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,68,91,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100619414","phase-1-a-phase-i-trial-of-a-car032-in-participants-with-mcrpc-100619414",false,"NCT07344311","A Phase I Trial of A-CAR032 in Participants With mCRPC","First Time-in-Human (FTiH), Phase I Trial to Evaluate the Safety, Cellular Kinetics, and Efficacy of A-CAR032, in Adult Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Participant must be 18 years or older at the time of signing the ICF. Type of Participant and Disease Characteristics\n2. Participants with:\n\n   1. A histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate without known neuroendocrine differentiation or small cell features.\n   2. Castration-resistant prostate cancer as defined by disease progression despite castration by orchiectomy or ongoing luteinising hormone-releasing hormone analogue. Participants receiving medical castration therapy with gonadotropin-releasing hormone analogues should continue this treatment during the study.\n   3. Measurable PSA≥1 ng\u002FmL AND\n   4. Evidence of progression within 6 months prior to screening\n3. Participant has previously received an ARPI (ie, abiraterone, enzalutamide, apalutamide, darolutamide, rezvilutamide) whether before or in the metastatic castration-resistant setting, and in the judgment of the investigator, be ineligible for standard treatment.\n4. Minimum life expectancy of \\> 12 weeks prior to apheresis in the opinion of the investigator.\n5. Adequate organ and marrow function\n6. Consent and provision of tumour material to assess STEAP2 expression and other correlative biomarkers retrospectively with pre- and post-treatment biopsies.\n7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n8. The participant voluntarily participates in the study, and the individual or their legal guardian signs the ICF.\n\nExclusion Criteria:\n\n1. Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).\n2. Contraindication to lymphodepleting agents, including fludarabine and\u002For cyclophosphamide.\n3. History of another primary malignancy except for:\n\n   1. Malignancy treated with curative intent and with no known active disease within 3 years before the apheresis and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n4. Participants with known brain metastases.\n5. History of splenectomy or organ transplantation.\n6. Prior treatment with:\n\n   1. Any CAR-T therapy. OR\n   2. Any therapy that is targeting STEAP2.\n7. Active or prior documented autoimmune or inflammatory disorders\n8. Cardiac arrhythmias which are symptomatic or require treatment unless controlled by pacemaker (judged by investigator); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.\n9. Active infection, including:\n\n   1. HBV infection is defined as hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and HBV DNA detectable.\n   2. HCV infection is defined as HCV antibody positive and HCV RNA positive.\n   3. CMV infection is defined as CMV DNA detectable.\n   4. Syphilis infection is defined as syphilis antigen and antibody positive.\n   5. HIV infection is defined as HIV 1\u002F2 antibody positive.\n   6. Other persistent or active infections requiring systemic treatment (prophylactic use of anti-infective drugs is allowed).\n10. Patients with central nervous system (CNS) diseases:\n11. Obvious risk or tendency of bleeding or active bleeding (eg, clinically significant hemoptysis, tumour bleeding, history of von Willebrand disease or hemophilia etc.).\n12. Plans to father a child during the study period.\n13. Patients with alcohol or drug abuse.\n14. Participants may not receive full-dose long acting oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose from the time of informed consent to 28 days post infusion of A-CAR032. Use of short acting direct oral anticoagulants for therapeutic and prophylactic purposes are permitted.\n15. Received the following:\n\n    1. Major surgery within 4 weeks prior to apheresis or existence of unhealed wound, or planned major surgery within 4 weeks of the study treatment administration\n    2. Steroids (except inhaled steroids) or other immunomodulators (including interleukins, interferons, and thymosins) of systemic therapeutic dose, and systemic corticosteroids at doses exceeding 10 mg\u002Fday of prednisone or equivalent within 5 half-lives or 7 days (whichever is shorter) prior to apheresis.\n16. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shorter) prior to apheresis.\n17. Radiotherapy within 4 weeks of apheresis (However, if the radiation portal covered ≤ 5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy); or within 6 months or 5 half-lives (whichever is longer) if local radioactive particle implantation was performed.","MALE","18 Years",{"count":19,"type":20},27,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This FTiH, single-arm, open-label, investigator-initiated Phase I trial will evaluate the safety, antitumour activity, CK\u002Fpharmacodynamics (PD), biomarkers, immunogenicity, and feasibility of A-CAR032 in adult participants with mCRPC, who have previously progressed after ARPI treatment of prostate cancer (whether before or in the metastatic castration-resistant setting) and, in the judgment of the investigator, are ineligible for standard treatment.",[26,27],"Prostate Cancer","Metastatic Castration-Resistant Prostate Cancer","RECRUITING","2026-05-29",{"date":31,"type":32},"2026-06-01","ACTUAL",{"date":34,"type":32},"2026-01-13",{"date":36,"type":20},"2042-01-31",{"name":38,"class":39},"Shanghai AbelZeta Ltd.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100627103","phase-1-an-phase-i-trial-of-a-car-t-cell-infusion-c-car031-in-participants-with-gpc3-advancedmetastatic-squamous-cell-lung-cancer-100627103","NCT07444281","An Phase I Trial of a CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced\u002FMetastatic Squamous Cell Lung Cancer","An Investigator-initiated Phase I Trial of an Armored and GPC3-targeted Autologous CAR T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced\u002FMetastatic Squamous Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable Stage IIIB ,IIIC or IV squamous cell lung cancer\n* Confirmed to express GPC3, as assessed by immunohistochemistry at a central lab\n* Participants who have progressed or intolerant to no more than three lines of prior systemic therapies for advanced\u002Fmetastatic squamous cell lung cancer\n* At least one measurable target lesion\n* The left ventricular ejection fraction (LVEF) measured by echocardiography ≥50% and reported as non-impaired.\n* Sufficient pulmonary function\n* The laboratory testing results meet the study requirements\n* Female participants of childbearing potential must test negative for pregnancy in serum or urine. Non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months and until CAR-T below lower limit of detection (LLOD) by PCR which occurs last after C-CAR031 infusion.\n\nExclusion Criteria:\n\n* known to harbor a driver mutation for which targeted standard therapy is recommended in accordance with local treatment guidelines.\n* Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO)\n* Contraindication to lymphodepleting agents, including fludarabine and\u002For cyclophosphamide.\n* History of splenectomy or organ transplantation\n* Prior treatment with Any CAR-T therapy OR any therapy that is targeting GPC3\n* Uncontrolled or intercurrent pulmonary disease\n* Clinically meaningful ascites\n* Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures\n* Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases\n* Received radiation therapy, local treatment, vaccine, blood transfusion, systemic treatment within certain period of apheresis required by study protocol\n* History of or with active diseases or conditions of that's defined in study protocol","ALL","75 Years",{"count":50,"type":20},24,[23],"This single-arm, open-label, multicenter, Phase I study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK)\u002Fpharmacodynamics (PD), biomarker, and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced\u002Fmetastatic squamous cell lung cancer, who are not amenable to curative therapy and have progressed or are intolerant to no more than 3 lines of prior systemic treatment including immune checkpoint inhibitors (CPIs) and platinum-based doublet chemotherapy, concurrently or sequentially.",[54],"Squamous Cell Lung Cancer",[56,57,58],"squamous cell lung cancer","advanced squamous cell lung cancer","metastatic squamous cell lung cancer","2026-02-27",{"date":61,"type":32},"2026-03-03",{"date":63,"type":32},"2024-12-25",{"date":65,"type":20},"2028-01-30",{"name":38,"class":39},1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":48,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100561444","phase-1-a-study-to-evaluate-c-car031-in-glypican-3-gpc3-advancedrecurrent-hepatocellular-carcinoma-hcc-100561444","NCT06590246","A Study to Evaluate C-CAR031 in Glypican-3 (GPC3)+ Advanced\u002FRecurrent Hepatocellular Carcinoma (HCC)","Phase I\u002FII Clinical Study of Armored and GPC3-targeted Autologous Chimeric Antigen Receptor (CAR) T-cell Infusion C-CAR031 in Participants With GPC3+ Advanced\u002FRecurrent Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. The participant voluntarily participates in the study, and the individual or their legal guardian signs the informed consent form (ICF).\n2. 18 \\~ 75 years of age at the time of signing ICF.\n3. Clinical trial participants with advanced HCC confirmed by histopathological or cytological examination with the following requirements (no mixed HCC-cholangiocarcinoma permitted):\n\n   * Barcelona Clinic Liver Cancer (BCLC) stage C or B (not amenable to surgery\u002Flocal treatment, includes ablative therapy, interventional and radiation therapy) or stage II-III ( not amenable to surgery\u002Flocal treatment, includes ablative therapy, interventional and radiation therapy) per China liver cancer staging (CNLC).\n   * Child-Pugh score ≤ 6.\n   * Participants must have a GPC3-positive tumor as determined by a central laboratory using an analytically validated IHC assay. Participants with unknown GPC3 status are not eligible for this study.\n4. Participants who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments; Systemic therapy intolerance is defined as: drug-related adverse reactions or side effects caused by systemic therapy (including but not limited to targeted therapy, immunotherapy) in patients with HCC that prevent patients from continuing treatment.\n5. At least one measurable target lesion (as defined by RECIST v1.1) that has not undergone prior local therapies such as radiotherapy (excluding lesions with radiologically confirmed progression after local therapy), and has not been utilized for research pre-screening biopsies (if only one target lesion exists and must undergo tissue biopsy, baseline tumor imaging must be performed at least 14 days after the biopsy).\n6. ECOG performance status score of 0 or 1.\n7. Minimal life expectancy ≥12 weeks, per the Investigator's discretion.\n8. The left ventricular ejection fraction (LVEF) measured by echocardiography ≥45% and reported as non-impaired. Measure must be within 28 days prior to apheresis.\n9. The laboratory testing results meet the following study requirements. Blood routine examination\n\n   * \\*Absolute Neutrophil Count (ANC) ≥1.0×10\\^9\u002FL.\n   * Absolute Lymphocyte count ≥ 0.3×10\\^9\u002FL.\n   * \\*Platelet count ≥ 75×10\\^9\u002FL.\n   * Hemoglobin ≥ 80g\u002FL. \\* With no transfusion or blood component transfusion received within 28 days prior to blood sampling or within 14 days prior to apheresis; or, with no granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulators administered as supportive treatment within 28 days prior to blood sampling or within 21 days prior to apheresis.\n\n   Blood biochemistry\n   * Serum total bilirubin ≤ 2.5×ULN (upper limit of normal) in the absence of Gilbert's syndrome, or ≤ 3×ULN if the patient has Gilbert's syndrome.\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5×ULN.\n   * Albumin ≥ 2.8 g\u002FdL.\n   * \\*Calculated creatinine clearance ≥30ml\u002Fmin. ＊As determined by Cockcroft-Gault equation using actual body weight.\n\n   Coagulation\n\n   • Prothrombin time International normalized ratio (PT-INR) ≤1.6.\n10. Participants with Hepatitis B virus (HBV) infection or history of infection (as characterized by positive HBsAg, \\[hepatitis B surface antigen\\], and\u002For detectable HBV DNA, and\u002For HbcAb \\[hepatitis B core antibody\\]) are eligible for inclusion only if:\n\n    * The participant is treated with antiviral therapy, as per institutional practice, to ensure adequate viral suppression (HBV DNA less than 2,000 IU\u002FmL or 10,000 copies\u002FmL).\n    * Participants who test positive for HBsAg and\u002For HBcAb must initiate standard antiviral therapy according to the most recent edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B at least 1 week prior to cell infusion, with tenofovir recommended as the preferred antiviral agent.\n11. Female participants of childbearing potential must test negative for pregnancy in serum or urine; non-sterilized participants (males and females) agree to take effective contraceptive measures for at least 12 months or CAR-T below lower limit of detection (LLD) by droplet digital polymerase chain reaction (ddPCR) whichever occurs first after C-CAR031 infusion (including participants who have only received lymphodepleting chemotherapy).\n\nExclusion Criteria:\n\n1. Known life-threatening allergies, hypersensitivity, or intolerance to the CAR-T product or its excipients, including dimethyl sulfoxide (DMSO).\n2. Known allergies to lymphodepleting agents, including fludarabine and\u002For cyclophosphamide.\n3. History of hepatic encephalopathy within past 6 months prior to apheresis or requirement for medications to prevent or control encephalopathy (eg, lactulose, rifaximin, etc infused for purposes of hepatic encephalopathy).\n4. Participants with central nerve system (CNS) diseases such as epilepsy, severe cerebral vascular stenosis, or those who have had a cerebral infarction or other cerebral vascular accidents within 6 months, or other diseases with obvious neurological symptoms (including mental illnesses).\n5. Uncontrolled or intercurrent cardiac or pulmonary diseases, including but not limited to, chronic obstructive pulmonary disease with obvious symptoms, and moderate or above persistent asthma, with a known history of non-infectious pneumonia requiring steroid treatment, or those presenting with acute exacerbation or progressive non-infectious pneumonia at baseline, unstable angina, severe arrhythmia, severe non-ischemic cardiomyopathy history or myocardial infarction or cardiac vascular surgery treatment occurred within 6 months.\n6. History of organ transplant including liver.\n7. Prior treatment with:\n\n   * Any CAR-T therapy. OR\n   * Any therapy that is targeting GPC3.\n8. The tumor volume is larger than 50% of the liver tissue.\n9. Main portal vein cancer embolus (Vp4, cancer embolus in the main trunk of the portal vein, with or without blood flow) on pre-LDC imaging.\n10. History of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered \"significant\") during the 3 months prior to apheresis.\n11. Clinically meaningful ascites, defined as any ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to apheresis. Participants on stable doses of diuretics for ascites for ≥ 2 months prior to apheresis are eligible.\n12. Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently).\n13. Cancer-related spinal cord compression, leptomeningeal disease, or brain metastases unless asymptomatic, treated, and stable radiologically (defined as 2 brain images, \\[both after treatment\\], should both be obtained at least 4 weeks apart and show no evidence of intracranial progression) and resolved or stable clinically; not requiring continuous corticosteroids at a dose above10 mg\u002Fday prednisone or equivalent for at least 4 weeks prior to apheresis.\n14. Received radiation therapy within 6 weeks of apheresis, or received local radioactive particle implantation within 6 months or 3 half-lives (whichever is longer).\n15. Received local treatment (such as: surgery, ablation, transarterial-chemoembolization \\[TACE\\]) within 4 weeks of apheresis, or existence of unhealed wound.\n16. Received inactivated or live attenuated vaccine within 4 weeks prior to apheresis.\n17. Blood transfusions within 14 days and\u002For growth factor support within 21 days prior to apheresis.\n18. Received systemic treatment and did not meet the minimum requirement for washout before apheresis:\n\n    * Immune checkpoint inhibitor: within 5 half-lives or 2 weeks (whichever is shorter).\n    * Chemotherapy, small molecule targeted therapy: within 5 half-lives or 2 weeks (whichever is shorter).\n    * Experimental anticancer drugs or other anti-cancer systemic treatment including Chinese herbal medicine, Chinese patent drug: within 5 half-lives or 2 weeks (whichever is shorter).\n    * Systemic dosing of steroid(s) (excluding: intranasal, inhaled, topical steroids or local steroid injections \\[eg, intra-articular injection\\]; systemic corticosteroids at physiologic doses not exceed 10mg\u002Fday of prednisone or its equivalent; steroids as premedication for hypersensitivity reaction \\[eg, computed tomography \\[CT\\] scan premedication\\]) or other immunomodulators (eg. Interleukins, interferons, thymosins, etc.): within 5 half-lives or 2 weeks (whichever is shorter).\n19. Has a history of other primary cancers, with exceptions of:\n\n    * Tumors with low metastatic potential that have been cured by excision (such as: basal cell carcinoma of the skin).\n    * Cured carcinoma in situ.\n20. History of or with active immunodeficiency diseases (including but not limited to HIV \\[Human immunodeficiency virus; positive HIV 1\u002F2 antibodies\\], systemic lupus erythematosus, inflammatory bowel disease, rheumatoid arthritis, myasthenia gravis, Graves disease, pituitary inflammation, multiple sclerosis, neuromyelitis optica spectrum disorders, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy, etc.; The following are exceptions: participants with vitiligo or alopecia, participants with hypothyroidism who have stabilized after hormone replacement therapy, any chronic skin disease that does not require systemic treatment, and other diseases that deemed not clinically significant per the Investigator's discretion).\n21. Active Hepatitis C virus infection (Hepatitis C virus \\[HCV\\] antibody positive and HCV RNA positive).\n22. According to the medical history, the participants who were known to have co-infection with HBV and hepatitis D virus (HDV).\n23. Syphilis infection (Syphilis antigen and antibody positive).\n24. Active infection requires systemic treatment (prophylactic administration of anti-infection medication is permitted; those who initiated antiviral therapy for HBV infection before screening must continue treatment throughout the study; for HBsAg-positive and\u002For HBcAb-positive participants not on antivirals before screening, antiviral therapy must be initiated at least 1 week prior to cell infusion, with tenofovir preferred as the antiviral agent).\n25. History of cardiac arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v5.0 Grade 3); unless controlled by pacemaker (discussion with the Study Physician required); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.\n26. Clear clinical evidence of dementia or changes in mental state.\n27. Heart failure: heart function of Class III or IV per the New York Heart Association (NYHA) heart function classification standards.\n28. Participants use full-dose long acting oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Use of short acting direct oral anticoagulants for therapeutic and prophylactic purposes are permitted.\n29. Participants with any of the following hemorrhage-related conditions: Active bleeding events ≥ Grade 3 (per NCI CTCAE v5.0) within 12 months prior to apheresis, Documented history of gastrointestinal variceal bleeding, or clinically significant history of upper gastrointestinal hemorrhage.\n30. Obvious risk or tendency of bleeding.\n31. Being in pregnancy or lactation period, or having plan to conceive during the study period.\n32. History or current evidence of any condition, therapy, or laboratory abnormality that, per the Investigator's discretion, might confound the results of the study, interfere with the participant's safety and\u002For study compliance.\n33. Major surgery within 2 weeks prior to apheresis, or has surgery planned during the study, or within a minimum of 4 weeks after study treatment administration. (Note: participants with planned surgical procedures to be conducted under local anaesthesia may participate).\n34. Any unresolved toxicity NCI CTCAE ≥ Grade 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values. Participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with study intervention including Grade 2 neuropathy maybe included after consultation with the Sponsor.\n35. Patients with alcohol or drug abuse.\n36. Participants with HLTV infection (HLTV antibody positive).",{"count":76,"type":20},121,[23,78],"PHASE2","This single-arm, open-label multicenter Phase I\u002FII study will evaluate the safety, tolerability, anti-tumor activity, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of C-CAR031 in adult participants with GPC3+ advanced\u002Frecurrent HCC, who have progressed or are intolerant to at least two prior lines of standardized systemic therapy, and lack of other effective treatments.",[81],"Hepatocellular Carcinoma","2025-12-28",{"date":84,"type":32},"2026-01-02",{"date":86,"type":32},"2024-09-30",{"date":88,"type":20},"2043-04-30",{"name":38,"class":39},2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100500801","phase-1-a-study-of-c-car039-prizloncabtagene-autoleucel-in-patients-with-relapsedrefractory-large-b-cell-lymphoma-100500801","NCT05800977","A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","A Phase 1b\u002F2 Study of a Anti-CD19\u002FCD20 Bispecific CAR-T Therapy (C-CAR039\u002FPrizloncabtagene Autoleucel) in Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","ELEVATION","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:\n\n  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)\n  2. Primary mediastinal large B-cell lymphoma (PMBCL)\n  3. Transformed follicular lymphoma (tFL)\n  4. High-grade B-cell lymphoma, with MYC and BCL2 and\u002For BCL6 rearrangements (HGBL-DH\u002FTH)\n  5. High-grade B-cell lymphoma, NOS (HGBL, NOS)\n  6. Follicular lymphoma grade 3B (FL3B)\n* Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)\n* At least one measurable lesion per the Lugano 2014 Classification\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis\n* Suspected or confirmed central nervous system involvement\n* Stroke or convulsion history within 6 months of signing informed consent form (ICF)\n* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment\n* Uncontrolled active infection\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test\n* Severe heart, liver, renal or metabolism disease\n* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis\n* Prior CAR-T therapy",{"count":100,"type":20},112,[23,78],"This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).",[104],"Relapsed\u002FRefractory Large B-Cell Lymphoma","2025-12-23",{"date":107,"type":32},"2025-12-31",{"date":109,"type":32},"2023-02-22",{"date":111,"type":20},"2028-06-30",{"name":38,"class":39},15,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":67},"100479347","phase-1-a-study-of-c-car088-in-patients-with-relapsed-or-refractory-multiple-myeloma-100479347","NCT05521802","A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma","A Phase Ib\u002FII Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria\n\n* ≥ 18 years of age, male or female patients\n* Relapsed or refractory multiple myeloma\n* Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.\n* Had measurable disease as defined by any of the following criteria:\n\n  * Serum M protein ≥ 0.5g\u002FdL\n  * Urine M protein ≥ 200mg\u002F24h\n  * Serum free light chain (sFLC): abnormal κ\u002Fλ ratio with involved sFLC ≥ 100mg\u002FL\n* Adequate liver, renal, bone marrow, and heart function\n* Eastern cooperative oncology group (ECOG) 0-1\n\nExclusion Criteria\n\n* Any known allergies to the components or excipients of the C-CAR088 cell product\n* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis\n* Central nervous system (CNS) involvement\n* Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)\n* Plasma leukemia\n* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment\n* Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection\n* Severe heart, liver, renal or metabolism disease\n* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis\n* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history\n* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial",{"count":122,"type":20},92,[23,78],"This is a multicenter, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.",[126],"Multiple Myeloma","2023-03-22",{"date":129,"type":32},"2023-03-24",{"date":131,"type":32},"2022-11-11",{"date":133,"type":20},"2037-07",{"name":38,"class":39},""]