[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-non-hodgkin-lymphoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,58,84,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":39,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255",false,"NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","ALL","3 Years","39 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[28,29,30,31,32,33,34,35,36,37,38],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","B-precursor ALL","B-All","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia","Acute Lymphoid Leukemia",[40,41,42,43,44,33,32,31,30,29],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","Adoptive Immunotherapy","RECRUITING","2026-06-30",{"date":48,"type":49},"2026-07-01","ACTUAL",{"date":51,"type":49},"2022-12-28",{"date":53,"type":21},"2029-07-01",{"name":55,"class":56},"National Cancer Institute (NCI)","NIH",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":57},"100588404","jy231jy231-injection-for-the-treatment-of-relapsedrefractory-b-cell-lymphoma-leukemia-100588404","NCT06940960","JY231(JY231) Injection for the Treatment of Relapsed\u002FRefractory B Cell Lymphoma\u002F Leukemia","An Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 12-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   1. Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   2. Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   3. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;\n   4. In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    1. Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    2. Grass aminotransferase (AST) ≤3 times ULN;\n    3. Total bilirubin ≤1.5 times ULN;\n    4. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    5. Indoor oxygen saturation ≥ 92%;\n    6. Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    7. There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    1. Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    2. Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    3. Platelet≥50.000\u002Fmm3;\n    4. Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    1. Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    2. Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    3. Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    4. Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    5. CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    1. Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    2. Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    3. The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n16. Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.","12 Years","75 Years",{"count":68,"type":21},20,[70],"NA","This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002F leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[73,29],"B Acute Lymphoblastic Leukemia","2025-06-05",{"date":76,"type":49},"2025-06-10",{"date":78,"type":49},"2025-05-30",{"date":80,"type":21},"2027-12",{"name":82,"class":83},"Affiliated Hospital of Guangdong Medical University","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":62,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":66,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":101,"locationsCount":57},"100584494","jy231jy231-injection-for-the-treatment-of-relapsedrefractory-b-cell-lymphoma-leukemia-100584494","NCT06890065","An Early-Phase Exploratory Clinical Study of JY231 Injection in Relapsed\u002FRefractory B-Cell Lymphoma\u002FLeukemia: Safety, Tolerability, and Preliminary Efficacy","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n\n16）Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.","18 Years",{"count":68,"type":21},[70],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002Fleukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[73,29],"2025-05-12",{"date":97,"type":49},"2025-05-15",{"date":99,"type":49},"2025-03-01",{"date":80,"type":21},{"name":102,"class":103},"Shenzhen Genocury Biotech Co., Ltd.","INDUSTRY",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":66,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":123,"locationsCount":57},"100583680","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-lymphoma-100583680","NCT06879470","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Lymphoma","An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Subjects voluntarily signed an informed consent form and were willing and able to comply with all study requirements;\n2. Age 18\\~75 years old, gender is not limited;\n3. Malignant tumor cells positive for Cluster of Differentiation 19(CD19);\n4. Meet the criteria for relapsed or refractory B-cell lymphoma. Relapsed: the subject's tumor reappears after achieving complete remission of the disease; refractory: the subject is ineffective or in only partial remission on standard treatment regimens. Subjects must have relapsed or become refractory after receiving at least two lines of systemic therapy or autologous hematopoietic stem cell transplantation.\n5. The presence of at least one measurable lesion on imaging of relapsed or refractory B-cell lymphoma, i.e., a lymph node lesion \\>15 mm in length or an extranodal lesion \\>10 mm in length based on CT cross-sectional images, along with a positive Fluorodeoxyglucose Computed Tomography(FDG-PET).\n6. Expected survival ≥12 weeks;\n7. Eastern Cooperative Oncology Group(ECOG) score of 0 to 1 at baseline;\n8. Good organ function (the standard can be appropriately relaxed for indicators involving liver and kidney function)\n\n   1. Albuminous aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN);\n   2. Albumin transaminase (AST) ≤ 3 times the ULN;\n   3. Total bilirubin ≤ 1.5 times the ULN;\n   4. Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL\u002Fmin;\n   5. Room oxygen saturation ≥92% without oxygen;\n   6. left ventricular ejection fraction (LVEF) ≥50%;\n9. Men of childbearing potential to ensure effective contraception for sexual partners; women of childbearing potential to use effective contraception and agree to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active central nervous system (CNS) lymphoma;\n2. Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n3. Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;\n4. Subjects who have had radiation therapy within 2 weeks prior to infusion;\n5. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);\n6. Subjects with unstable angina and\u002For myocardial infarction within 6 months prior to Screening;\n7. Subjects with other prior or concurrent malignancies, with the following exceptions:\n\n   1. Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);\n   2. Carcinoma in situ of the cervix or breast, curatively treated, with no sign of recurrence for at least 3 years prior to study entry;\n   3. Primary malignant tumor that has been completely resected and in complete remission for ≥ 5 years.\n8. Presence of subjects with arrhythmias not controlled by medical management;\n9. Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n10. Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;\n11. Subjects who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the study procedures or have other medical conditions that may place them at unacceptable risk.\n12. Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.",{"count":112,"type":21},24,[70],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma.",[29],"NOT_YET_RECRUITING","2025-03-11",{"date":119,"type":49},"2025-03-17",{"date":121,"type":21},"2025-03",{"date":80,"type":21},{"name":124,"class":83},"He Huang"]