[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-acute-lymphoblastic-leukemia-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-acute-lymphoblastic-leukemia-adult":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,90],{"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":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":44},"100617071","phase-1-a-study-of-inotuzumab-and-blinatumomab-in-people-with-b-cell-acute-lymphoblastic-leukemia-100617071",false,"NCT07313852","A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years of age.\n* Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics\n\n  * Patients ≥55 years old, OR\n  * Patients 18-54 years old who decline or are deemed unfit for conventional chemotherapy with at least one of the following criteria:\n* ECOG performance status of 2 or more\n* Severe cardiac comorbidity (including congestive heart failure requiring treatment)\n* Known pulmonary comorbidity (including DLCO ≤65% or FEV1 ≤65%)\n* Renal comorbidity (including creatinine clearance 30-45 mL\u002Fmin)\n* Relapsed or refractory CD19+ and CD22+ B-ALL\n* Patients with extramedullary disease will be allowed as long as they have detectable disease by flow cytometry in the bone marrow\n* Peripheral absolute lymphoblast count of ≤ 10,000\u002Fml after pre-phase (not required for enrollment but required to proceed with first dose of inotuzumab).\n* Philadelphia chromosome negative by FISH\u002Fkaryotype for t(19;22) or RT PCR for bcr-abl transcript.\n* CD19 and CD22 expression will be confirmed by enrolling institutions prior to study registration by flow cytometry and\u002For IHC.\n* Creatinine clearance ≥30 mL\u002Fmin\n* Total bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤3.0x upper limit of normal (ULN)\n* QTcF ≤ 480\n* Ejection fraction ≥ 50%\n\nExclusion Criteria:\n\n* Patients with Burkitt's lymphoma, T-ALL, CML in lymphoid blast crisis and mixed phenotype acute leukemia (MPAL).\n* Patients with newly diagnosed B-ALL who received prior treatments, with the exception of corticosteroid, hydroxyurea, or one dose of vincristine, are ineligible.\n* Patients with Ph+ B-ALL by FISH or RT PCR.\n* ECOG performance status \\>3.\n* Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* History of sinusoidal obstruction syndrome (SOS), also known as veno-occlusive disease (VOD).\n* Prior treatment with inotuzumab\n* History of liver cirrhosis\n* Ongoing need for systemic T-cell suppressive therapy (e.g. corticosteroids, tacrolimus, cyclosporine, etc.) Patients need to be off calcineurin inhibitors for at least 4 weeks in order to be eligible for enrollment.\n* Active Grade 2-4 acute graft versus host disease (GVHD), graded with the modified Glucksberg criteria and\u002For GVHD requiring systemic steroids in excess of physiologic replacement\n* Moderate or severe chronic GVHD graded with the NIH 2014 criteria\n* Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for the following time periods: female patients of reproductive potential should use effective contraception during treatment and for 8 months after last treatment dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 5 months after the last dose.\n* Patients with HIV or active hepatitis B or hepatitis C infection are ineligible. Patients with a prior history of hepatitis B or hepatitis C who have negative HBV\u002FHCV PCR respectively at the time of screening are eligible\n* Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I\u002FII cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, or severe brain injuries.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.","ALL","18 Years","55 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).",[28,29,30],"B-cell Acute Lymphoblastic Leukemia","B-Cell Acute Lymphoblastic Leukemia, Adult","B-ALL",[28,29,30,32],"Memorial Sloan Kettering Cancer Center","NOT_YET_RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-16","ACTUAL",{"date":39,"type":21},"2026-06",{"date":41,"type":21},"2029-01",{"name":32,"class":43},"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":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100614277","early-phase-1-autologous-bedside-cd19-car-t-cell-therapy-for-b-all-100614277","NCT07277504","Autologous Bedside CD19 CAR T-cell Therapy for B-ALL","Clinical Study on the Safety and Efficacy of Bedside CD19 CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age 18 to 70 years inclusive at the time of signing informed consent.\n* Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.\n* CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.\n* Life expectancy ≥12 weeks in the opinion of the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as:\n\n  * Creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN)\n  * Total bilirubin ≤1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤2.5 × ULN is acceptable)\n* For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective contraceptive methods from the screening period through 12 months after CAR-T cell infusion. Women are considered not of childbearing potential if they are postmenopausal for at least 1 year or have documented evidence of surgical sterilization or congenital infertility. Women who are pregnant or breastfeeding are excluded from this study.\n* Ability to understand and willingness to provide written informed consent prior to initiation of any study-specific procedures.\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including long-term follow-up for up to 15 years.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for enrollment:\n\n* Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.\n* History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.\n* Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).\n* Radioimmunotherapy or radiotherapy within 8 weeks prior to enrollment.\n* Receipt of live attenuated vaccine within 4 weeks prior to screening.\n* Current or anticipated use of systemic corticosteroids at high dose (defined as a total cumulative dose equivalent to ≥60 mg dexamethasone or equivalent corticosteroid) within 4 weeks prior to lymphodepletion chemotherapy. Physiologic replacement doses, topical, inhaled, nasal, and ophthalmic corticosteroids are permitted.\n* Active acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to CAR-T cell infusion.\n* Major surgical procedure within 3 months prior to screening.\n* Active CNS disorder or history of irreversible severe CNS toxicity from prior B-ALL therapy resulting in organic brain lesions or CNS dysfunction, including but not limited to seizure disorder, cerebrovascular accident, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n* History of hypertensive crisis or hypertensive encephalopathy within 3 months prior to screening.\n* Any uncontrolled cardiovascular disease within 6 months prior to enrollment, or any of the following:\n\n  * Ventricular or atrial arrhythmia ≥Grade 2\n  * Bradycardia ≥Grade 2\n  * Myocardial infarction\n  * Severe or unstable angina pectoris\n  * Symptomatic congestive heart failure\n  * Cerebrovascular accident or transient ischemic attack\n  * Pulmonary embolism\n  * Deep vein thrombosis\n  * Poorly controlled hypertension despite standard medical management\n  * Left ventricular ejection fraction (LVEF) \\\u003C45% as assessed by echocardiography or multigated acquisition (MUGA) scan at screening\n* Any uncontrolled pulmonary disease within 6 months prior to enrollment, or any of the following:\n\n  * Pulmonary embolism\n  * Chronic obstructive pulmonary disease\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis\n  * Evidence of active pneumonia on chest computed tomography (CT) scan at screening\n  * Symptomatic or uncontrolled interstitial lung disease\n  * Clinically significant pulmonary function abnormalities Note: History of radiation pneumonitis\u002Fpulmonary fibrosis in a radiation field is permitted if asymptomatic.\n* Active bacterial, fungal, protozoal, or viral infection that is not adequately controlled despite appropriate therapy at the time of enrollment, or positive blood culture within 7 days prior to enrollment.\n* Known active infection with any of the following:\n\n  * Hepatitis B virus (HBV): Positive HBV surface antigen (HBsAg) or HBV core antibody (HBcAb) with detectable HBV DNA above the normal range\n  * Hepatitis C virus (HCV): Positive HCV antibody with detectable HCV RNA above the normal range\n  * Human immunodeficiency virus (HIV): Positive HIV antibody\n  * Human T-lymphotropic virus (HTLV): Positive HTLV antibody\n  * Treponema pallidum (syphilis): Positive T. pallidum antibody\n  * Cytomegalovirus (CMV): Positive CMV DNA by polymerase chain reaction (PCR)\n* Legally incapacitated individuals under guardianship or conservatorship.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study or ability to provide informed consent.\n* Any abnormal finding, medical condition, or laboratory test result during screening that, in the investigator's judgment, may jeopardize patient safety or interfere with study conduct or interpretation of results.\n* Any planned medical or surgical intervention that would interfere with the conduct of the study.\n* Contraindication to any medication that may be required during the study, including but not limited to lymphodepletion chemotherapy agents (fludarabine, cyclophosphamide) and medications for management of adverse reactions (e.g., tocilizumab for CRS management, corticosteroids for ICANS management).","70 Years",{"count":54,"type":21},50,[56],"EARLY_PHASE1","The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product.\n\nThe main questions it aims to answer are:\n\n1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL?\n2. Which dose level is the optimal biological dose (OBD)?\n3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?\n\nParticipants will:\n\n1. Receive autologous bedside CD19 CAR T-cell therapy on Day 0.\n2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.\n3. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.",[29],[60,61,30],"CAR-T","CAR T-cell therapy","2025-11-29",{"date":64,"type":37},"2025-12-11",{"date":66,"type":21},"2025-12-01",{"date":68,"type":21},"2031-12-31",{"name":70,"class":43},"The General Hospital of Western Theater Command",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":89,"locationsCount":44},"100612651","early-phase-1-allogeneic-ucb-derived-car-t-for-b-all-100612651","NCT07256353","Allogeneic UCB-derived CAR-T for B-ALL","Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for B Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age 18 to 70 years inclusive at the time of signing informed consent.\n* Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.\n* CD19 expression or CD20 confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.\n* Life expectancy ≥8 weeks in the opinion of the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status score \\\u003C4.\n* Adequate organ function as demonstrated by the most recent assessment during the screening period, defined as:\n\n  * Creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × upper limit of normal (ULN)\n  * Total bilirubin ≤- 1.5 × ULN (for patients with documented Gilbert's syndrome, total bilirubin ≤- 2.5 × ULN is acceptable)\n* For women of childbearing potential (WOCBP), a negative serum pregnancy test must be documented within 7 days prior to enrollment. WOCBP and male patients with partners who are WOCBP must agree to use highly effective contraceptive methods from the screening period through 12 months after CAR-T cell infusion. Women are considered not of childbearing potential if they are postmenopausal for at least 1 year or have documented evidence of surgical sterilization or congenital infertility. Women who are pregnant or breastfeeding are excluded from this study.\n* Ability to understand and willingness to provide written informed consent prior to initiation of any study-specific procedures.\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including long-term follow-up for up to 15 years.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.\n* History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.\n* Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).\n* Radioimmunotherapy or radiotherapy within 8 weeks prior to enrollment.\n* Receipt of live attenuated vaccine within 4 weeks prior to screening.\n* Current or anticipated use of systemic corticosteroids at high dose (defined as a total cumulative dose equivalent to ≥60 mg dexamethasone or equivalent corticosteroid) within 4 weeks prior to lymphodepletion chemotherapy. Physiologic replacement doses, topical, inhaled, nasal, and ophthalmic corticosteroids are permitted.\n* Active acute or chronic graft-versus-host disease (GVHD) requiring systemic treatment within 4 weeks prior to CAR-T cell infusion.\n* Major surgical procedure within 3 months prior to screening.\n* Active CNS disorder or history of irreversible severe CNS toxicity from prior B-ALL therapy resulting in organic brain lesions or CNS dysfunction, including but not limited to seizure disorder, cerebrovascular accident, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.\n* History of hypertensive crisis or hypertensive encephalopathy within 3 months prior to screening.\n* Any uncontrolled cardiovascular disease within 6 months prior to enrollment, or any of the following:\n\n  * Ventricular or atrial arrhythmia ≥Grade 2\n  * Bradycardia ≥Grade 2\n  * Myocardial infarction\n  * Severe or unstable angina pectoris\n  * Symptomatic congestive heart failure\n  * Cerebrovascular accident or transient ischemic attack\n  * Pulmonary embolism\n  * Deep vein thrombosis\n  * Poorly controlled hypertension despite standard medical management\n  * Left ventricular ejection fraction (LVEF) \\\u003C45% as assessed by echocardiography or multigated acquisition (MUGA) scan at screening Pulmonary Exclusions\n* Any uncontrolled pulmonary disease within 6 months prior to enrollment, or any of the following:\n\n  * Pulmonary embolism\n  * Chronic obstructive pulmonary disease\n  * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis\n  * Evidence of active pneumonia on chest computed tomography (CT) scan at screening\n  * Symptomatic or uncontrolled interstitial lung disease\n  * Clinically significant pulmonary function abnormalities Note: History of radiation pneumonitis\u002Fpulmonary fibrosis in a radiation field is permitted if asymptomatic.\n* Active bacterial, fungal, protozoal, or viral infection that is not adequately controlled despite appropriate therapy at the time of enrollment, or positive blood culture within 7 days prior to enrollment.\n* Known active infection with any of the following:\n\n  * Hepatitis B virus (HBV): Positive HBV surface antigen (HBsAg) or HBV core antibody (HBcAb) with detectable HBV DNA above the normal range\n  * Hepatitis C virus (HCV): Positive HCV antibody with detectable HCV RNA above the normal range\n  * Human immunodeficiency virus (HIV): Positive HIV antibody\n  * Human T-lymphotropic virus (HTLV): Positive HTLV antibody\n  * Treponema pallidum (syphilis): Positive T. pallidum antibody\n  * Cytomegalovirus (CMV): Positive CMV DNA by polymerase chain reaction (PCR)\n* Legally incapacitated individuals under guardianship or conservatorship.\n* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study or ability to provide informed consent.\n* Any abnormal finding, medical condition, or laboratory test result during screening that, in the investigator's judgment, may jeopardize patient safety or interfere with study conduct or interpretation of results.\n* Any planned medical or surgical intervention that would interfere with the conduct of the study.\n* Contraindication to any medication that may be required during the study, including but not limited to lymphodepletion chemotherapy agents (fludarabine, cyclophosphamide) and medications for management of adverse reactions (e.g., tocilizumab for CRS management, corticosteroids for ICANS management).",{"count":54,"type":21},[56],"The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the allogeneic, umbilical cord blood-derived CAR-T cell product.\n\nThe main questions it aims to answer are:\n\n1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and UCAR-T-related adverse events (AEs) after the UCAR-T cell infusion?\n2. Which dose level is the optimal biological dose (OBD)?\n3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?\n\nParticipants will:\n\n1. May receive lymphodepletion chemotherapy if clinically indicated: fludarabine (30 mg\u002Fm²\u002Fd, days -5, -4, and -3) and cyclophosphamide (300-500 mg\u002Fm²\u002Fd, days -5 and -4).\n2. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1.\n3. Receive UCAR-T cells infusion on Day 0.\n4. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.\n5. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after UCAR-T cells infusion, with continued long-term follow-up for safety and persistence.",[29],[83,84,30],"allogeneic CAR-T","umbilical cord blood-derived","2025-11-20",{"date":66,"type":37},{"date":66,"type":21},{"date":68,"type":21},{"name":70,"class":43},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":111,"locationsCount":44},"100569637","early-phase-1-allogeneic-cd19-targeted-car-t-cell-infusion-therapy-in-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100569637","NCT06696833","Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed\u002FRefractory B Cell Acute Lymphoblastic Leukemia","Assessment of the Safety and Efficacy of Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed\u002FRefractory B Cell Acute Lymphoblastic Leukemia: A Single-Arm, Open-Label, Prospective Study","Inclusion Criteria:\n\n1. Age ≥14 years, gender not specified;\n2. Diagnosed with B-ALL according to the World Health Organization (WHO) classification of hematopoietic and lymphoid tissue tumors (2022 version);\n3. Meet the diagnosis of relapsed\u002Frefractory leukemia, excluding isolated extramedullary relapse; For relapsed or refractory B-ALL, including any of the following situations: a) Relapse: Peripheral blood or bone marrow recurrence of primitive cells \\>5% or extramedullary lesions appear again after complete remission; b) Refractory: Primary refractory patients who fail to achieve complete remission after standard induction chemotherapy；those with positive measurable residual disease can also be included；\n4. Flow cytometry confirms positive CD19 expression in leukemia cells；\n5. Estimated survival \\>3 months;\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;\n7. The vital organs function in accordance with the following requirements:\n\n   7.1Left ventricular ejection fraction (LVEF) ≥50%; 7.2Pulmonary function：normal oxygen saturation without oxygen supplementation; 7.3Total bilirubin (TBil) ≤3×upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3×ULN； 7.4Creatinine ≤1.5×ULN;\n8. Pregnancy test must be negative, and fertile non-abstinent female patients must agree to use effective contraception from the start of self-screening to 1 year after cell infusion. Fertile male patients with fertile partners must agree to use effective contraception from the start of self-screening to 1 year after cell infusion, and should not donate semen or sperm throughout the study period；\n9. No obvious hereditary diseases；\n10. The subject and their legal guardian voluntarily participate in this study, understand the trial information and objectives, and provide informed consent with a signed and dated signature.\n\nExclusion Criteria:\n\n1. Patients with severe autoimmune diseases or immunodeficiency diseases;\n2. Patients with a history of severe central nervous system diseases, such as uncontrolled seizures, stroke, severe brain injury resulting in aphasia, paralysis, dementia, Parkinson's disease, psychiatric disorders, etc.;\n3. Any unstable diseases occurring within screening period (including but not limited to): unstable angina, ischemic or cerebrovascular accidents, myocardial infarction, severe arrhythmias requiring drug treatment (such as rapid atrial fibrillation, high-degree atrioventricular block, ventricular tachycardia, ventricular fibrillation, or torsades de pointes), cardiac catheterization or coronary artery stenting, or coronary artery bypass surgery, thrombotic or embolic events.\n4. Active graft-versus-host disease requiring continued systemic therapy;\n5. The presence of anti-FMC63 and a positive DSA reaction;\n6. Patients who have previously received CAR-T cell therapy within 6 months or donor lymphocyte infusion within 6 weeks before screening;\n7. History of or concomitant active malignant tumors, excluding cured non-invasive basal cell or squamous cell skin cancer, uterine cervical carcinoma in situ or localized prostate cancer or breast ductal carcinoma in situ without recurrence for at least 2 years;\n8. Presence of other severe medical conditions as determined by the investigator, such as uncontrolled hypertension or diabetes, severe renal insufficiency, severe pulmonary dysfunction, etc.;\n9. Other severe or persistent active infections;\n10. Other conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.","14 Years",{"count":99,"type":21},18,[56],"This clinical trial aims to investigate the safety, optimal dosage, and effectiveness of allogeneic CD19-targeted CAR-γδT Cell in treating CD19-positive relapsed\u002Frefractory B-ALL",[29],[30],"RECRUITING","2024-11-17",{"date":107,"type":37},"2024-11-20",{"date":109,"type":21},"2024-12-01",{"date":66,"type":21},{"name":112,"class":43},"The First Affiliated Hospital of Soochow University"]