[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Liping Dou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,74,93,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100645053","phase-1-blinatumomab-combined-with-low-dose-dli-as-maintenance-therapy-after-transplantation-for-b-all-100645053",false,"NCT07677878","Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","A Single-arm, Open-label, Phase I Clinical Study of Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL","Inclusion Criteria:\n\n* 1\\) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing\u002Fable to comply with all trial procedures.\n\n  2\\) Age: \\\u003C70 years old at screening, any gender. 3) Diagnosis: High-risk acute B-lymphoblastic leukemia (B-ALL) with MRD-negative status post-transplant. High-risk factors include:\n  * \\>CR1 status\n  * Pre-transplant MRD+ status\n  * Ph-like subtype\n  * KMT2A rearrangement\n  * Other high-risk cytogenetic\u002Fgenetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤ ULN. 7) Other conditions: Absence of uncontrolled infections or severe psychiatric disorders.\n\n    8\\) Performance status: ECOG score 0-3, with life expectancy ≥ 4 months. 9) MRD status: Bone marrow flow cytometry confirmed MRD-negative before enrollment.\n\n    10\\) Engraftment: Evidence of myeloid and platelet engraftment. 11) GVHD: No active graft-versus-host disease (GVHD).\n\nExclusion Criteria:\n\n* 1\\) Drug hypersensitivity\u002Fcontraindications: Patients with known allergies or contraindications to the investigational drug(s).\n\n  2\\) Pregnancy\u002Flactation: Pregnant or breastfeeding female patients. 3) Active infection\u002FGVHD: Patients with active infection or active graft-versus-host disease (GVHD).\n\n  4\\) Substance abuse: Patients with chronic heavy smoking or alcohol use that may interfere with clinical evaluation.\n\n  5\\) Impaired consent\u002Fcompliance: Patients unable to provide informed consent or comply with procedures due to psychiatric\u002Fneurological disorders.\n\n  6\\) Recent major surgery: Patients who underwent major organ surgery within the past 6 weeks.\n\n  7\\) Organ dysfunction:\n* Liver: ALT or AST \\> 2.5 × ULN; Total bilirubin \\> 2 × ULN\n* Kidney: Serum creatinine \\> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).","ALL","18 Years","70 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This prospective study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.",[27],"ALL (Acute B-Lymphoblastic Leukemia)",[29,30,31],"high-risk B-cell ALL","Blinatumomab","donor lymphocyte infusion","RECRUITING","2026-06-28",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2024-12-01",{"date":40,"type":21},"2028-12-01",{"name":42,"class":43},"Liping Dou","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":44},"100639863","phase-1-exploratory-study-of-cd22cd19-dual-target-car-t-cell-therapy-as-consolidation-treatment-after-first-remission-in-high-risk-b-cell-acute-lymphoblastic-leukemia-100639863","NCT07575971","Exploratory Study of CD22\u002FCD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia","An Exploratory Study on Targeted CD22\u002FCD19 Chimeric Antigen Receptor (CAR)-T Cell Immunotherapy for Enhanced Consolidation Therapy After Initial Remission in High-risk B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment, laboratory tests, and other study-related assessments.\n2. Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia\u002Flymphoma (B-ALL\u002FLBL) according to WHO 2022 criteria, with CD19-positive and\u002For CD22-positive disease. Patients must have achieved first morphological complete remission (CR1; bone marrow blasts \\\u003C5%) after standard induction chemotherapy. Patients may or may not have achieved deep remission, defined as minimal residual disease (MRD) negativity assessed by flow cytometry and\u002For molecular methods (e.g., quantitative PCR or next-generation sequencing).\n3. Patients who are eligible for enhanced consolidation therapy. Patients with high-risk disease defined as:\n\n   High-risk group based on cytogenetic and molecular features, regardless of MRD status after consolidation; or Standard-risk group with persistent MRD positivity after two cycles of consolidation therapy, indicating a high risk of relapse.\n\n   In addition, patients are unwilling or ineligible to allogeneic hematopoietic stem cell transplantation, and are planned to receive CAR-T cell therapy as consolidation treatment.\n4. Age between 18 and 85 years, regardless of sex.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Estimated life expectancy ≥3 months.\n7. Hemoglobin ≥60 g\u002FL (transfusion allowed).\n8. Absolute neutrophil count ≥1,000\u002FμL and platelet count ≥45,000\u002FμL.\n9. Adequate organ function, defined as:\n\n   Total bilirubin ≤1.5 × upper limit of normal (ULN) (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant arrhythmia, and no pericardial effusion; Baseline oxygen saturation \\>92% on room air; No clinically significant pleural effusion.\n10. Subjects of reproductive potential must agree to use effective contraception from enrollment until at least 6 months after completion of the study. Subjects who are pregnant or suspected to be pregnant must notify the investigator immediately.\n\nExclusion Criteria:\n\n1. Patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation (meeting any of the following), who are planned to receive allogeneic hematopoietic stem cell transplantation or CD19\u002FCD3 bispecific antibody (blinatumomab) therapy and refuse CAR-T cell immunotherapy as consolidation treatment, including any of the following conditions:\n\n   ① Early relapse within 6 months after achieving first complete remission;\n\n   ② Primary refractory disease, defined as failure to achieve first morphological complete remission after two cycles of standard first-line induction chemotherapy;\n\n   ③ Failure to achieve complete remission or relapse after first-line or multiple lines of salvage chemotherapy;\n\n   ④ Relapse after allogeneic hematopoietic stem cell transplantation.\n2. Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.\n3. Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n\n   (Active HBV infection is defined as: HBV DNA ≥2000 IU\u002FmL, ALT ≥2×ULN, and exclusion of other causes of hepatitis.)\n4. Non-disease-related hepatic or renal dysfunction defined as:\n\n   ALT or AST \\>3×ULN; Total bilirubin \\>2×ULN; Creatinine clearance \\\u003C30 mL\u002Fmin.\n5. History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.\n6. Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary disease, autoimmune disease, immunodeficiency, or uncontrolled infections.\n7. History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.\n8. Pregnant or breastfeeding women.\n9. Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.\n10. History of other malignancies unless disease-free for at least 3 years without active treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ).\n11. Receipt of live vaccines within 6 weeks prior to initiation of lymphodepleting chemotherapy.\n12. Major surgery within 14 days prior to enrollment or planned major surgery during the study period.\n13. Any other condition that, in the investigator's judgment, may increase risk, interfere with study results, or make the patient unsuitable for the study.","85 Years",{"count":54,"type":21},30,[24,56],"PHASE2","This single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22\u002FCD19 dual-target chimeric antigen receptor T-cell (CAR-T) therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first remission after standard induction therapy and consolidation chemotherapy. Approximately 30 patients will be enrolled. Participants will undergo screening, cell collection for CAR-T manufacturing, lymphodepleting chemotherapy, and subsequent CAR-T cell infusion, followed by scheduled safety and efficacy follow-up. Safety assessments will include monitoring for cytokine release syndrome (CRS), neurotoxicity, hematologic toxicity, organ toxicity, infections, and other adverse events. Efficacy assessments will include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), duration of response(DOR), relapse, and mortality. Exploratory analyses will assess CAR-T cell kinetic characteristics and clonal evolution after treatment.",[59],"B-cell Acute Lymphoblastic Leukemia",[61,62,63,64,65],"B-Cell Acute Lymphoblastic Leukemia","CAR-T Cell Therapy","Dual-Target CAR-T","CD19","CD22","2026-06-23",{"date":68,"type":36},"2026-06-25",{"date":70,"type":36},"2026-01-01",{"date":72,"type":21},"2027-12-31",{"name":42,"class":43},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":86,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":91,"leadSponsor":92,"locationsCount":44},"100642430","phase-1-targeted-cd22cd19-car-t-therapy-for-consolidation-in-standard-risk-b-all-100642430","NCT07575919","Targeted CD22\u002FCD19 CAR-T Therapy for Consolidation in Standard-Risk B-ALL","An Exploratory Study on Targeted CD22\u002FCD19 Chimeric Antigen Receptor (CAR)-T Cell Immunotherapy for Enhanced Consolidation Therapy of Standard-risk B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment, laboratory tests, and other study-related assessments.\n2. Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia\u002Flymphoma (B-ALL\u002FLBL) according to WHO 2022 criteria, with CD19-positive and\u002For CD22-positive disease. Patients must have achieved first morphological complete remission (CR1; bone marrow blasts \\\u003C5%) after standard induction chemotherapy. Patients may or may not have achieved deep remission, defined as minimal residual disease (MRD) negativity assessed by flow cytometry and\u002For molecular methods (e.g., quantitative PCR or next-generation sequencing).\n3. Adult patients with standard-risk B-cell acute lymphoblastic leukemia , as defined by cytogenetic and molecular risk stratification and without high-risk features, who have achieved complete remission (CR) after treatment, received two cycles of long-course intensive consolidation chemotherapy, maintained sustained bone marrow MRD negativity by multiparameter flow cytometry (MFC) and sustained molecular MRD negativity by real-time quantitative polymerase chain reaction (RT-qPCR) or next-generation sequencing (NGS), are not considered to require allogeneic hematopoietic stem cell transplantation (allo-HSCT) for consolidation, and refuse or are ineligible to receive CD19\u002FCD3 bispecific antibody therapy (e.g., blinatumomab), and are therefore planned to receive CAR-T cell immunotherapy as enhanced consolidation therapy followed by long-term maintenance treatment.\n4. Age between 18 and 85 years, regardless of sex.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Estimated life expectancy ≥3 months.\n7. Hemoglobin ≥60 g\u002FL (transfusion allowed).\n8. Absolute neutrophil count ≥1,000\u002FμL and platelet count ≥45,000\u002FμL.\n9. Adequate organ function, defined as:\n\nTotal bilirubin ≤1.5 × upper limit of normal (ULN) (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant arrhythmia, and no pericardial effusion; Baseline oxygen saturation \\>92% on room air; No clinically significant pleural effusion.\n\n10\\. Subjects of reproductive potential must agree to use effective contraception from enrollment until at least 6 months after completion of the study. Subjects who are pregnant or suspected to be pregnant must notify the investigator immediately.\n\nExclusion Criteria:\n\n1. Patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation, who are planned to receive allogeneic hematopoietic stem cell transplantation or CD19\u002FCD3 bispecific antibody (blinatumomab) therapy and refuse CAR-T cell immunotherapy as consolidation treatment, including any of the following conditions:\n\n   ① Early relapse within 6 months after achieving first complete remission;\n\n   ② Primary refractory disease, defined as failure to achieve first morphological complete remission after two cycles of standard first-line induction chemotherapy;\n\n   ③ Failure to achieve complete remission or relapse after first-line or multiple lines of salvage chemotherapy;\n\n   ④ Relapse after allogeneic hematopoietic stem cell transplantation;\n\n   ⑤ Persistent MRD positivity with a high risk of relapse.\n2. Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.\n3. Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.\n\n   (Active HBV infection is defined as: HBV DNA ≥2000 IU\u002FmL, ALT ≥2×ULN, and exclusion of other causes of hepatitis.)\n4. Non-disease-related hepatic or renal dysfunction defined as:\n\n   ALT or AST \\>3×ULN; Total bilirubin \\>2×ULN; Creatinine clearance \\\u003C30 mL\u002Fmin.\n5. History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.\n6. Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary disease, autoimmune disease, immunodeficiency, or uncontrolled infections.\n7. History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.\n8. Pregnant or breastfeeding women.\n9. Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.\n10. History of other malignancies unless disease-free for at least 3 years without active treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ).\n11. Receipt of live vaccines within 6 weeks prior to initiation of lymphodepleting chemotherapy.\n12. Major surgery within 14 days prior to enrollment or planned major surgery during the study period.\n13. Any other condition that, in the investigator's judgment, may increase risk, interfere with study results, or make the patient unsuitable for the study.",{"count":82,"type":21},20,[24,56],"This is a single-center, open-label, single-arm prospective study designed to evaluate the safety, tolerability, and efficacy of dual-target CD22\u002FCD19 chimeric antigen receptor (CAR)-T cell therapy as consolidation treatment in patients with standard-risk B-cell acute lymphoblastic leukemia (B-ALL) in remission. Eligible patients will undergo leukapheresis for CAR-T cell manufacturing, followed by lymphodepleting chemotherapy and CAR-T cell infusion. Patients will be closely monitored for safety, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and infections. Efficacy endpoints include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), relapse rate, and mortality. Exploratory analyses will assess CAR-T cell expansion kinetics and clonal evolution. The total follow-up duration is planned to be 2 years.",[59],[61,62,63,64,65],"2026-06-11",{"date":89,"type":36},"2026-06-15",{"date":70,"type":36},{"date":72,"type":21},{"name":42,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":44},"100638630","phase-2-cd19cd22-car-t-as-first-line-consolidation-in-follicular-lymphoma-100638630","NCT07587840","CD19\u002FCD22 CAR-T as First-line Consolidation in Follicular Lymphoma","A Study of CD19\u002FCD22 CAR-T Cell Therapy as First-line Consolidation Treatment in Patients With Follicular Lymphoma","Inclusion Criteria:\n\n* 1\\. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures;\n* 2\\. CD19 and\u002For CD22-positive follicular lymphoma (FL) confirmed by histology according to the WHO classification:\n\n  1. The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or\n  2. The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset;\n* 3\\. The possible high-risk factors for the patient's onset of the disease are as follows: Presence of at least one of the following high-risk features at diagnosis:\n\n  1. Follicular Lymphoma International Prognostic Index (FLIPI-1) score of 3-5 or FLIPI-2 score of 3-5;\n  2. Presence of any lymph node or extranodal mass \\>6 cm in diameter;\n  3. Significant infiltration of CD68+ or CD163+ macrophages by immunohistochemistry;\n  4. Gene sequencing revealing TP53 or NOTCH1 mutation;\n  5. Presence of 1p36 deletion or 1q amplification;\n  6. Next-generation sequencing (NGS)-defined high-risk mutation-based 7-gene Follicular Lymphoma International Prognostic Index (m7-FLIPI) subtype.\n* 4\\. Age range from 18 to 85 years old, male or female;\n* 5\\. Subjects with physical fitness status scores ranging from 0 to 2 in the Eastern Cooperative Oncology Group (ECOG) in the United States;\n* 6\\. Expected survival period from the date of signing the informed consent form is greater than 3 months;\n* 7\\. HGB ≥ 60g\u002FL;\n* 8\\. The absolute value of neutrophils in peripheral blood is ≥ 1000\u002Fμl, and the platelet count is ≥ 45000\u002Fμl;\n* 9\\. Liver and kidney function, as well as heart and lung function, meet the following requirements:\n\n  1. Total bilirubin (TBIL) ≤ 1.5 times the upper limits of normal (ULN), except for subjects with Gilbert's syndrome;\n  2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN;\n  3. Serum Creatinine (Cr) ≤ 1.5 times ULN or Creatinine Clearance Rate (CCr) ≥ 60mL\u002Fmin, estimated based on the Cockcroft Gault formula;\n  4. The left ventricular ejection fraction (LVEF) of the heart is ≥ 50%. Echocardiography (ECHO) confirms no pericardial effusion and no clinically significant arrhythmia;\n  5. Baseline transcutaneous oxygen saturation under indoor ventilation\\>92%;\n  6. No clinically significant pleural effusion;\n* 10\\. Participants with pregnancy plans must agree to take contraceptive measures for a continuous period of 6 months from before enrollment in the study until the end of the study; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately.\n\nExclusion Criteria:\n\n* 1\\. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy;\n* 2\\. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications;\n* 3\\. Known history of human immunodeficiency virus (HIV) infection or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as:\n\n  1. HBV DNA quantification ≥ 2000 IU\u002Fml;\n  2. ALT ≥ 2 times the normal upper limit value;\n  3. Exclude hepatitis caused by the disease itself, medication, or other reasons; All three conditions must be met simultaneously. If a patient is diagnosed with active HBV infection at the time of initial diagnosis and becomes non active HBV infection after anti HBV treatment, they can be included in this study under the premise of sufficient anti HBV treatment;\n* 4\\. Non hematological tumors (such as lymphoma) associated liver and kidney dysfunction: ALT\\>3 times the upper limit of normal, AST\\>3 times the upper limit of normal, TBIL\\>2 times the upper limit of normal, serum creatinine clearance rate\\\u003C30 mL\u002Fmin;\n* 5\\. History of myocardial infarction, cardiac angioplasty or coronary stent implantation, unstable angina, active arrhythmia, or other clinically significant cardiovascular diseases within the 12 months prior to enrollment;\n* 6\\. Other serious medical diseases may have an impact on this study (such as diabetes, gastric ulcer, other serious respiratory and circulatory diseases, severe autoimmune diseases or congenital immune defects, severe infection and inability to be effectively controlled), as well as other diseases with high risk of disease change;\n* 7\\. Has a history of severe immediate hypersensitivity reactions to any medication necessary for use in this study; History of severe allergy to biological products (including antibiotics);\n* 8\\. Female subjects who are currently pregnant or breastfeeding (with potential risks to the fetus or infant from pre-treatment chemotherapy regimens);\n* 9\\. The researchers determined that the subjects were unable to complete all the required visit surveys or diagnostic procedures (including medium - and long-term follow-up visits) as per the study protocol, had poor willingness to participate in the study, were unwilling to join and fully comply with the study arrangements, and had insufficient compliance with the study by the subjects and their families. The decision-making power belongs to the researcher;\n* 10\\. The subjects who have previously suffered from other malignant tumors cannot be included in this study unless they are disease-free and have not received any form of anti-tumor treatment for at least 3 years (except for skin tumors of non malignant melanoma and in situ cancers occurring in the cervix, bladder, breast, etc.);\n* 11\\. History of receiving live vaccines within 6 weeks prior to initiating the pre-treatment plan;\n* 12\\. Those who have undergone large-scale surgical treatment (excluding lymph node biopsy) within the past 14 days, or those who are expected to undergo large-scale surgical treatment during the treatment process;\n* 13\\. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients deemed unsuitable by the researchers to participate in this study.",{"count":82,"type":21},[56],"The purpose of this study is to determine the efficacy and safety of CD19\u002FCD22 Chimeric Antigen Receptor (CAR) T-Cell immunotherapy as first-line consolidation therapy in patients with follicular lymphoma.",[104],"Lymphoma","2026-05-11",{"date":107,"type":36},"2026-05-14",{"date":70,"type":36},{"date":110,"type":21},"2028-01-01",{"name":42,"class":43},{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100637392","early-phase-1-in-vivo-bcmagprc5d-tandem-dual-car-t-therapy-for-relapsedrefractory-plasma-cell-neoplasms-100637392","NCT07586709","In Vivo BCMA\u002FGPRC5D Tandem Dual CAR-T Therapy for Relapsed\u002FRefractory Plasma Cell Neoplasms","A Clinical Study on the Safety of in Vivo-CAR-T Cell Immunotherapy Targeting BCMA\u002FGPRC5D for the Treatment of Relapsed\u002FRefractory Plasma Cell Neoplasms","Inclusion Criteria:\n\n* Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.\n* Diagnosis of relapsed or refractory plasma cell neoplasms meeting the following criteria:\n\n  1. Clonal plasma cells confirmed to be BCMA and\u002For GPRC5D positive by flow cytometry or immunohistochemistry;\n  2. Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)\n* Age 18 to 75 years (inclusive), male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Life expectancy \\> 3 months from the date of informed consent.\n* Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion allowed).\n* Adequate organ function (hepatic, renal, cardiac, and pulmonary):\n\n  1. Creatinine ≤ 2 × ULN;\n  2. Left ventricular ejection fraction (LVEF) ≥ 50%;\n  3. Oxygen saturation \\> 90%;\n  4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN.\n* Willingness to use highly effective contraception from signing of informed consent until 1 year after SL4903 infusion.\n\nExclusion Criteria:\n\n* Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 50%.\n* History of severe pulmonary impairment.\n* Concurrent diagnosis of another active malignancy.\n* Uncontrolled active infection.\n* History of severe autoimmune disease or primary immunodeficiency.\n* Active hepatitis (defined as HBV DNA or HCV RNA above the lower limit of detection).\n* Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or active syphilis.\n* History of severe hypersensitivity to biological products (including antibiotics).\n* Allogeneic hematopoietic stem cell transplant recipients with ongoing acute graft-versus-host disease (GVHD) despite discontinuation of immunosuppressive therapy for at least one month prior to screening.\n* Any other severe comorbidities or laboratory abnormalities that, in the investigator's opinion, would increase the risk to the subject or interfere with study results, rendering the subject unsuitable for participation.\n* Pregnant or breastfeeding women (including women of childbearing potential who are pregnant or lactating).","75 Years",{"count":121,"type":21},18,[123],"EARLY_PHASE1","This study aims to assess the safety profile of in vivo BCMA\u002FGPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.",[126],"Plasma Cell Neoplasms",[128,129,130,131],"in vivo CAR-T Cell Therapy","BCMA","GPRC5D","plasma cell neoplasms","NOT_YET_RECRUITING","2026-05-07",{"date":107,"type":36},{"date":136,"type":21},"2026-05-09",{"date":138,"type":21},"2029-03-31",{"name":42,"class":43},""]