[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-acute-lymphoblastic-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,45,0,25,[9,41,77,105,132,156,174,197,223,245,266,295,329,363,385,410,430,451,485,515,538,560,583,609,634],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644935","phase-1-phase-1-study-of-kite-753-in-rr-b-cell-all-100644935",false,"NCT07674823","Phase 1 Study Of KITE-753 in R\u002FR B-Cell ALL","A Phase 1 Study Evaluating The Safety And Efficacy Of KITE-753, Autologous Anticd19\u002FCD20 CAR T-Cell Therapies, In Patients With Relapsed And\u002FOr Refractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients ≥18 years of age with relapsed and\u002For refractory B-cell ALL after 1 or more lines of therapy with ≥5% and \\\u003C75% bone marrow blasts at the time of consent\n* Blasts should be positive (≥1%) for either CD19 or CD20 as assessed by flow-cytometry or positive for either CD19 or CD20 by immunohistochemistry\n* Patients with Philadelphia chromosome-positive ALL are eligible if they are intolerant or have failed 2 lines of any TKI or one line of second-generation TKI\n* ECOG performance status ≤2\n* Adequate organ function: Creatinine clearance \\>50 ml\u002Fmin, direct bilirubin ≤1.5 mg\u002FdL, AST\u002FALT ≤5.0 x ULN (except in patients with leukemia involvement where up to 10 x ULN is allowed), left ventricular ejection fraction \\>40%\n* The effects of KITE-753 on the developing human fetus are unknown. For this reason and because chemotherapy used in this trial is known to be teratogenic, women of childbearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least 12 months after the last dose of study treatment. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after the last dose of study treatment.\n* Ability to understand and willingness to sign a written informed consent document\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Patients who have received prior CAR T-cell therapy or other cell therapies\n* History of CTCAE grade 4 neurologic event or grade 4 CRS (Lee 2014 criteria) with prior CD19-directed therapy\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requires IV antimicrobials for management Note: Simple urinary tract infections and uncomplicated bacterial or viral upper respiratory tract infections are permitted if the participant is responding to active treatment and satisfies the criteria of being afebrile for 48 hours (i.e., temperature \\\u003C 38°C).\n* Symptomatic CNS disease (i.e. cranial nerve palsies) at the time of enrollment. Patients could have prior history of CNS disease but no symptomatic CNS disease at the time of study enrollment.\n* Presence of CNS-3 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3) with or without neurological changes, and presence of CNS-2 disease (defined as detectable cerebrospinal blast cells in a sample of CSF with \\\u003C5 WBCs per mm3) with neurological changes Note: Subjects with CNS-1 (no detectable leukemia in the CSF) and those with CNS-2 without clinically evident neurological changes are eligible to participate in the study.\n* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia (grade 2 or higher memory impairment per CTCAEv5.0), Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade ≥3) CNS events including ICANS from T cell engager therapies.\n* Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment\n* Diagnosis of Burkitt's leukemia\u002Flymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis\n* Current uncontrolled autoimmune disease\n* History of Hemophagocytic lymphohistiocytosis \u002F Macrophage activation syndrome\n* Prior medication:\n\n  * Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to enrollment\n  * Treatment with alemtuzumab within 6 months prior to enrollment, clofarabine or cladribine within 3 months prior to enrollment, or PEG-asparaginase within 3 weeks prior to enrollment\n  * Donor lymphocyte infusion (DLI) within 28 days prior to enrollment\n  * Any drug used for GVHD within 4 weeks prior to enrollment (e.g., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide), or immunosuppressive antibody used within 4 weeks prior to enrollment (e.g., antiCD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor)\n  * Corticosteroid therapy at a pharmacologic dose (\\>5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive drugs must be avoided for 7 days prior to enrollment\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients unable\u002Funwilling to sign informed consent form\n* Because no dosing or adverse event data are currently available on the use of KITE-753 in patients \\\u003C18 years of age, children are excluded from this study\n* Human Immunodeficiency Virus (HIV)-positive unless taking appropriate anti-HIV medications, having an undetectable viral load by qPCR, and a CD4 count ≥200 cells\u002FµL\n* Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants, secondary to treatment of the mother with KITE753, breastfeeding should be discontinued if the mother is treated with KITE-753\n* WOCBP must have a negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization\n* Patients of either sex who are not willing to practice highly effective birth control from the time of informed consent through 12 months after lymphodepleting chemotherapy or the KITE-753 administration, whichever is longer","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical research study is to find the recommended dose of KITE-753 in patients with relapsed\u002Frefractory B-cell ALL. The safety of KITE-753 will also be studied.",[27],"B-cell Acute Lymphoblastic Leukemia","NOT_YET_RECRUITING","2026-06-26",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":21},"2026-12-31",{"date":36,"type":21},"2031-04-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100369743","phase-3-study-of-out-of-specification-for-tisagenlecleucel-100369743","NCT04094311","Study of Out of Specification for Tisagenlecleucel","A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication","Key inclusion criteria:\n\n* Signed informed consent\u002Fassent must be obtained for this study prior to participation in the study.\n* Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.\n* Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country\u002Fregion.\n* OOS material has not been deemed to pose an undue safety risk to the patient.\n* Patient is suffering from a serious or life-threatening disease or condition.\n* Repeat leukapheresis is not clinically appropriate per the investigator assessment.\n\nKey exclusion criteria:\n\nFor part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:\n\n* Human immunodeficience virus (HIV) positive patients.\n* Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).\n* Patients with primary central nervous system (CNS) lymphoma.\n* History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.\n* Uncontrolled active infection or inflammation.\n* Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.\n* Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.","0 Years","100 Years",{"count":51,"type":21},200,[53],"PHASE3","This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.",[27,56],"Diffuse Large B-cell Lymphoma",[58,59,60,61,62,63,64],"out of specification","tisagenlecleucel","acute lymphoblastic leukemia","large B-cell lymphoma","relapsed\u002Frefractory","pediatric","young adult patients","RECRUITING","2026-06-24",{"date":68,"type":32},"2026-06-25",{"date":70,"type":32},"2019-11-21",{"date":72,"type":21},"2027-03-31",{"name":74,"class":75},"Novartis Pharmaceuticals","INDUSTRY",54,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":40},"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":86,"type":21},30,[24,88],"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.",[27],[92,93,94,95,96],"B-Cell Acute Lymphoblastic Leukemia","CAR-T Cell Therapy","Dual-Target CAR-T","CD19","CD22","2026-06-23",{"date":68,"type":32},{"date":100,"type":32},"2026-01-01",{"date":102,"type":21},"2027-12-31",{"name":104,"class":39},"Liping Dou",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":40},"100459442","phase-1-ngs-mrd-assessment-of-combination-immunotherapies-targeting-b-all-100459442","NCT05262673","NGS-MRD Assessment of Combination Immunotherapies Targeting B-ALL","NGS-MRD Evaluation of Antigen-specific T Cells and DC Vaccine Combination Targeting B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age older than 6 months.\n2. High-burden (≥30% blast cells) B-ALL tumor specimen for clonal IgH identification and CTL\u002FDC vac preparation is required\n3. Expression of CD19, CD22, CD20, CD10 or CD123 is determined in malignant cells by flow cytometry or immuno-histochemical staining.\n4. Karnofsky performance status (KPS) score is higher than 60 and life expectancy \\> 3 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5x upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n6. No cell separation contraindications.\n7. Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n2. Active bacterial, fungal or viral infection not controlled by adequate treatment.\n3. Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. Pregnant or nursing women may not participate.\n5. History of glucocorticoid for systemic therapy within the week prior to entering the test.\n6. Previously treatment with any gene therapy products.\n7. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","6 Months","65 Years",{"count":115,"type":21},10,[24],"The purpose of this study is to determine the feasibility, safety, and efficacy of a combination therapy in the treatment of B-cell acute lymphoblastic leukemia (B-ALL) based on multi-antigen-targeted chimeric antigen receptor T cells (CAR-T) followed by engineered immune effector cytotoxic T lymphocytes (CTLs) and immune-modified dendritic cell vaccine (DCvac). This approach is aimed to achieve NGS MRD negative in B-ALL patients, which can identify a very low risk of relapse and define patients with possible long-term remission without further treatment.",[92],[120,121,122,123],"B-ALL","CAR T","CTL","DC vaccine","2026-06-18",{"date":97,"type":32},{"date":127,"type":32},"2026-06-01",{"date":129,"type":21},"2030-12-31",{"name":131,"class":39},"Shenzhen Geno-Immune Medical Institute",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":40},"100617071","phase-1-a-study-of-inotuzumab-and-blinatumomab-in-people-with-b-cell-acute-lymphoblastic-leukemia-100617071","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.","55 Years",{"count":141,"type":21},26,[24,88],"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).",[27,145,120],"B-Cell Acute Lymphoblastic Leukemia, Adult",[27,145,120,147],"Memorial Sloan Kettering Cancer Center","2026-06-15",{"date":150,"type":32},"2026-06-16",{"date":152,"type":21},"2026-06",{"date":154,"type":21},"2029-01",{"name":147,"class":39},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":173,"locationsCount":40},"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":164,"type":21},20,[24,88],"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.",[27],[92,93,94,95,96],"2026-06-11",{"date":148,"type":32},{"date":100,"type":32},{"date":102,"type":21},{"name":104,"class":39},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":187,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},"100610087","phase-3-a-study-of-fludarabine-dosing-in-children-and-young-adults-with-b-cell-acute-lymphoblastic-leukemia-100610087","NCT07223021","A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia","Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)","Inclusion Criteria:\n\n* Patients with B-ALL and eligible to receive commercial tisagenlecleucel.\n* Patient's weight \\> 9 kg at time of lymphodepleting chemotherapy\n* Adequate organ function at time of LD is required and is defined:\n\n  * Hepatic: Serum bilirubin ≤ 2 mg\u002FdL, unless benign congenital hyperbilirubinemia\n  * Hepatic: AST and ALT \\\u003C 5x the upper limit of normal for age, unless thought to be leukemic disease-related\n  * Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml\u002Fmin\u002F1.73m\\^2. (based on Schwartz formula GFR (mL\u002Fmin\u002F1.73 m²) = (36.2 × Height in cm) \u002F Creatinine in mg\u002FdL\n  * Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening\n  * Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnofsky \\> 60% at treatment\n  * Age \\\u003C 16 years: Lansky ≥ 60% at treatment\n* Willing to participate as research subject and provide written informed consent from parents\u002Flegal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.\n\nExclusion Criteria:\n\n* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.\n* Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol\n* Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA etc.)\n* Patient\u002Fparent\u002Fguardian unable to give informed consent or unable to comply with the treatment protocol.\n* Pregnant or lactating women","1 Year",{"count":183,"type":21},130,[53],"The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.",[27],[188],"Fludarabine",{"date":190,"type":32},"2026-06-12",{"date":192,"type":32},"2025-10-20",{"date":194,"type":21},"2028-10",{"name":147,"class":39},5,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":112,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100546451","phase-1-substudy-01a-zilovertamab-vedotin-in-pediatric-and-young-adult-participants-with-hematologic-malignancies-or-solid-tumors-mk-9999-01alightbeam-u01-100546451","NCT06395103","Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A\u002FLIGHTBEAM-U01)","LIGHTBEAM-U01 Substudy 01A: A Phase 1\u002F2 Substudy to Evaluate the Safety and Efficacy of Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* For hematological malignancies: Confirmed diagnosis of B-precursor B-ALL or DLBCL\u002FBurkitt lymphoma according to World Health Organization (WHO) classification of neoplasms of the lymphoid tissues.\n* For solid tumor malignancies: Histologically confirmed diagnosis of neuroblastoma or Ewing sarcoma.\n\nExclusion Criteria:\n\n* History of solid organ transplant.\n* Clinically significant (ie, active) cardiovascular disease.\n* Known history of liver cirrhosis.\n* Ongoing Grade \\>1 peripheral neuropathy.\n* Demyelinating form of Charcot-Marie-Tooth disease.\n* Diagnosed with Down syndrome.\n* Ongoing graft-versus-host disease (GVHD) of any grade or receiving systemic GVHD treatment or prophylaxis.\n* History of human immunodeficiency virus (HIV) infection.\n* Contraindication or hypersensitivity to any of the study intervention components.\n* Received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities.\n* Ongoing, chronic corticosteroid therapy (exceeding 10 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks before Cycle 1 Day 1 (C1D1).\n* Received a strong cytochrome P450 3A4 (CYP3A4) inhibitor within 7 days or a strong CYP3A4 inducer within 14 days before the start of study intervention or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during the study intervention period and for 30 days after the last dose of study intervention\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention (except for prophylactic intrathecal chemotherapy and\u002For cytoreductive therapy with steroids\u002Fhydroxyurea.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.\n* Known additional malignancy that is progressing or has required active treatment within the past 1 year.\n* Active infection requiring systemic therapy.\n* Known history of Hepatitis B or known active Hepatitis C virus infection.\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications.","25 Years",{"count":206,"type":21},90,[24,88],"Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), diffuse large B-cell lymphoma (DLBCL)\u002FBurkitt lymphoma, or neuroblastoma and in pediatric and young adult participants with Ewing sarcoma.",[27,56,210,211,212],"Burkitt Lymphoma","Neuroblastoma","Ewing Sarcoma","2026-06-04",{"date":215,"type":32},"2026-06-08",{"date":217,"type":32},"2024-08-16",{"date":219,"type":21},"2029-03-31",{"name":221,"class":75},"Merck Sharp & Dohme LLC",70,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":230,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100636783","phase-2-a-clinical-trial-of-mk-1045-in-people-with-b-cell-acute-lymphoblastic-leukemia-mk-1045-005-100636783","NCT07570173","A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)","A Phase 2\u002F3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* Has a confirmed diagnosis of relapsed\u002Frefractory (R\u002FR) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow\n* Has CD19+ disease, confirmed by local flow cytometry and\u002For immunohistochemistry testing at the time of enrollment\n* Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment\n* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Has Burkitt's leukemia\n* History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic\u002Fischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis\n* Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded\n* History of serious cardiovascular and cerebrovascular diseases.\n* HIV-infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Isolated extramedullary disease (EMD)\n* Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement\n* Active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications","12 Years",{"count":232,"type":21},340,[88,53],"Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R\u002FR B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.",[27],"2026-06-03",{"date":238,"type":32},"2026-06-05",{"date":240,"type":32},"2026-05-18",{"date":242,"type":21},"2033-10-18",{"name":221,"class":75},3,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":40},"100583670","phase-1-evaluating-the-safety-and-efficacy-of-duocar201922-d95-in-adult-patients-with-relapsed-or-refractory-b-cell-malignancies-100583670","NCT06879340","Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","A Phase 1 Multicenter, Open Label Trial Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. Ability of participant to understand this study, and participant willingness to sign a written informed consent\n2. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to the start of preparatory regimen\n3. Patients must have histologically confirmed aggressive B-Cell NHL or ALL as stated below:\n\n   A. Patients with relapsed or refractory B-Cell ALL i. Demonstration of one or more antigens of interest (CD19, CD20, CD22) in most recent disease evaluation prior to study entry and within 30 days of study entry.\n\n   ii. Patients with relapsed\u002Frefractory disease in blood, marrow, and extramedullary sites including CSF will be eligible when there is immunophenotypic evidence of CD19 and\u002For CD20 and\u002For CD22 expression\n\n   iii. Primary refractory disease at study entry defined as: A morphologic complete response has never been achieved prior to study entry.\n\n   iv. Early first relapse at study entry defined as: Disease recurrence by morphologic assessment after duration of first remission at ≤ 18 months\n\n   v. Relapsed Refractory disease (first or later relapse) at study entry defined as: Morphologic complete response was not achieved after initiation of a second-line (or later) systemic therapy\n\n   vi. Second or greater relapse at study entry defined as: Any disease recurrence following a second or later complete response (with treatment history including two or more lines of systemic therapy)\n\n   vii. Additional considerations beyond above criteria:\n   * Patients with relapsed or refractory disease after allogeneic stem cell transplantation must be \\>100 days from HSCT to be eligible for study participation. Furthermore, post-HSCT immunosuppressive medications must be discontinued for at least 4 weeks prior to study entry\n   * Prior CAR-T therapy is permissible if ≥ 3 months from therapy completion\n   * Morphological disease in the bone marrow Note: Morphologic disease is defined as blasts being at least 5% in the bone marrow.\n\n   B. Histologically confirmed aggressive B cell NHL, including the following types defined by WHO 2008 after 2 or more lines of prior therapy:\n\n   i. DLBCL not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV)+ DLBCL of the elderly; Primary cutaneous DLBCL, leg type; OR ii. Primary mediastinal (thymic) large B cell lymphoma iii. Follicular lymphoma 3b and transformation of follicular lymphoma to DLBCL will also be included iv. High-grade B cell lymphoma v. Chemotherapy-refractory disease, defined as one or more of the following:\n   * Refractory disease is defined as progressive or stable disease as the best response to the most recent prior therapy or relapse within 12 months of autologous stem cell transplantation. Two prior lines of therapy are required for LBCL eligibility. The second line therapy may be chemotherapy based, autologous stem cell transplantation, or CAR-T.\n   * Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n   * Patients must have received 2 or more lines of adequate prior therapy including at a minimum:\n\n     * anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20- negative and\n     * an anthracycline containing chemotherapy regimen\n     * for patients with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL vi. Prior CAR T therapy permissible if ≥ 3 months from the therapy vii. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy C. Relapsed or refractory indolent non-Hodgkin lymphoma i. Histologically confirmed indolent non-Hodgkin lymphoma, including grade 1-3b follicular lymphoma or nodal or extranodal marginal zone lymphoma (both per WHO 2016 classification criteria) ii. Relapsed or refractory disease (per Lugano criteria) after two or more previous lines of therapy, iii. Previous lines of therapy to include an anti-CD20 monoclonal antibody combined with an alkylating agent iv. Prior CAR T therapy permissible if ≥ 3 months from the therapy v. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy vi. Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment D. Relapsed or Refractory Mantle-Cell Lymphoma i. Histologically confirmed mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14) ii. Disease that is either relapsed or refractory to at least 2 prior lines of previous regimens for mantle-cell lymphoma iii. Previous therapy must have included anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, and BTK inhibitor therapy\n4. Prior CAR T therapy permissible if ≥ 3 months from the therapy\n5. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\n6. Relapsed or refractory disease after allogeneic transplant provided patient is ≥ 3 months from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment\n7. Meet institutional criteria for leukapheresis procedure or have availability of previously- collected and stored leukapheresis product that satisfies minimum requirements\n8. Eastern cooperative oncology group (ECOG) performance status of 0 to 2.\n9. Adequate hematologic and organ function NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.\n10. Adults ≥ 18 years of age, with no upper limit of age\n11. Life expectancy \\>2 months\n12. ≥ 3 months from prior CAR\n13. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential\u002FPregnancy section from the time of signing informed consent to at least 12 months following DuoCAR20.19.22-D95 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. Men must agree not to donate sperm for the same time period.\n\nExclusion Criteria:\n\n1. Patients with CLL, Richter's transformation, and Burkitt lymphoma\n2. Active CNS involvement by malignancy - CNS3 disease, i.e., patients with WBC count in CSF ≥5 and having blasts in the CSF in patients with ALL or detection of NHL on CSF by flow cytometry or active CNS involvement on imaging)\n3. Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion\n4. Investigational medicinal product within the last 30 days prior to screening Note: Investigational therapies must not be used at any time while on study until the first progression following DuoCAR20.19.22-D95 CAR T infusion.\n5. The following medications are excluded:\n\n   1. Steroids: Therapeutic doses of steroids must be stopped \\> 72 hours prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C12 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n   2. Immunosuppression: Any other immunosuppressive medication must be stopped ≥ 2 weeks prior to leukapheresis and ≥ 2 weeks prior to DuoCAR20.19.22-D95 infusion. This could include check point inhibitors (monoclonal antibodies and small molecule modulators).\n   3. Antiproliferative therapies other than lymphodepleting chemotherapy within 2 weeks prior to infusion\n   4. Short acting drugs used to treat leukemia or lymphoma (e.g., tyrosine kinase inhibitors, and hydroxyurea) must be stopped \\> 72 hour prior to leukapheresis and \\> 72 hours prior to DuoCAR20.19.22-D95 infusion\n   5. Other cytotoxic drugs, including low dose daily or weekly maintenance chemotherapy, must not be given within 2 weeks prior to leukapheresis and within 2 weeks prior to DuoCAR20.19.22-D95 infusion.\n   6. Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5 half-lives of the respective antibody, whichever is longer. Note: Rituximab is excluded within 4 weeks prior to infusion.\n   7. CNS disease prophylaxis or treatment must be stopped \\> 1 week prior to DuoCAR20.19.22-D95 infusion (e.g., intrathecal methotrexate)\n6. Prior radiation therapy within 2 weeks of infusion\n7. Active replication of or prior infection with hepatitis B or active hepatitis C (HCV RNA positive)\n8. HIV positive patients (excluding false positive HIV test resulting from the viral vector used in prior CAR T)\n9. Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g., blood culture positive ≤ 72 hours prior to infusion)\n10. Unstable angina and\u002For myocardial infarction within 6 months prior to screening\n11. Previous or concurrent malignancy with the following exceptions:\n\n    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n    3. A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n12. Simultaneously enrolled in any therapeutic clinical trial (except for long-term follow up studies)\n13. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n14. Either diagnosed with a psychiatric illness or under the impact of a social situation that would limit compliance with study requirements in the opinion of the investigator\n15. Is pregnant or breastfeeding\n16. Intolerance to the excipients of the cell product\n17. Cardiac arrhythmia not controlled with medical management\n18. Active COVID-19 (follow ASTCT guidelines)\n19. Presence of active grade 2 to 4 acute, extensive chronic graft-versus-host disease (GVHD) or that require systemic steroids\n20. Patients with active neurological auto immune or inflammatory disorders (e.g., Guillain-Barré Syndrome, Amyotrophic Lateral Sclerosis)",{"count":76,"type":21},[24],"This multicenter phase 1 trial with \"3 + 3\" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19\u002F20\u002F22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.",[256,27],"B-Cell Non-Hodgkin Lymphoma","2026-05-11",{"date":259,"type":32},"2026-05-14",{"date":261,"type":32},"2025-03-31",{"date":263,"type":21},"2040-03",{"name":265,"class":39},"University of Kansas Medical Center",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":17,"minAge":273,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":40},"100404304","phase-1-ucd19-cart-in-treatment-of-pediatric-b-all-and-b-nhl-100404304","NCT04544592","UCD19 CarT in Treatment of Pediatric B-ALL and B-NHL","Phase I\u002FII Dose Escalation and Preliminary Efficacy of CD19 Directed CAR-T Cells Generated Using the Miltenyi CliniMACs Prodigy System (UCD19 CAR-T) in Pediatric Patients With Relapsed and\u002For Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL) and B-Cell Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n* Meets clinical criteria for leukapheresis or has a leukapheresis product previously collected and stored per recommended guidelines.\n* Provision of signed and dated consent form from parent or guardian (patients \\\u003C18), the patient themselves (\\>18), or legally authorized representative (patient \\>18 who lack decision-making capacity); Pediatric patients will be included in age-appropriate discussions and assent will be obtained for those \\> 7 years of age, when appropriate, according to institutional standards.\n* Willingness to participate in long term follow up study.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Males OR non-pregnant, non-breastfeeding females.\n\n  o Patients of child-bearing potential or capable of fathering a child must agree to use highly effective contraception from the time of initial CAR T cell administration though 12 months following the final administration of investigational product.\n* Aged 31 days to 30 years (inclusive) at time of consent and enrollment.\n* Acute Lymphoblastic Leukemia (ALL) OR Non-Hodgkin Lymphoma (NHL) of B-cell origin that:\n\n  * Has confirmed expression of CD19 by flow cytometry, immunohistochemistry (IHC), or both.\n\nCohort One Criteria:\n\n* Meets any one of the following conditions:\n\n  * Relapsed two or more times\n  * Relapsed at any time after allogeneic BMT\n  * Refractory to standard therapy as determined by the treating physician\n  * Meets criteria for BMT but is ineligible as determined by the treating physician Patient and\u002For parents declining BMT options and would prefer CAR-T Therapy.\n* Non-Hodgkin Lymphoma includes all of the following:\n\n  * Diffuse large B-cell lymphoma (DLBCL)\n  * Burkitt Lymphoma\n  * Intermediate lymphoma between Burkitt and DLBCL\n  * Primary Mediastinal B-cell Lymphoma (PMBL)\n  * Follicular lymphoma\n  * High grade B cell lymphoma\n  * Transformed lymphoma\n\nCohort Two Criteria:\n\n* B-ALL in first relapse with any one of the following conditions:\n\n  * High-risk genomic alterations at initial diagnosis such as KMT2A gene rearrangement, t(17;19), hypodiploidy, Ph-like mutations, BCR-ABL1 fusion (Ph+ ALL), iAMP21, and TP53 inactivating mutation\u002Fdeletion.\n  * Isolated CNS relapse such that cranial radiation would be indicated as a component of standard salvage therapy.\n  * Down syndrome.\n  * Minimal residual disease (MRD) positivity of \\> 0.01% by FACS or \\> 0 clonal sequences by NGS in bone marrow post re-induction chemotherapy.\n  * Age 18 years or older. OR Newly diagnosed with persistent MRD ≥ 0.01% by flow cytometry in bone marrow at end of consolidation.\n* Performance score (Lansky or Karnofsky) of 50% or better;\n* Unable to or declined to receive commercially available CD19 CAR-T Therapy.\n\nExclusion Criteria:\n\n* Evidence of rapidly progressive disease without adequate salvage\u002Fbridging regimens as determined by the investigator.\n* Active Graft-versus-Host Disease (GvHD).\n* Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe leukapheresis or tolerance of LD chemotherapy, cell infusion, or cytokine release syndrome.\n* Evidence of severe organ dysfunction as defined by:\n\n  * Myocardial dysfunction: Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG) findings.\n  * Baseline oxygen saturation of ≤ 90% on room air\n  * Transaminases \\> 10x upper limit of normal (ULN) or bilirubin \\>2x the ULN, unless thought to be related to primary disease\n  * Estimated Cr clearance \\\u003C60 mL\u002Fmin\u002F1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)\n* Post-pubertal females that are pregnant, planning to become pregnant, or unwilling to use birth control (includes abstinence) for the study duration.\n* Known HIV infection, or active Hepatitis B or active Hepatitis C infection.","31 Days","30 Years",{"count":5,"type":21},[24,88],"This phase I\u002FII trial will investigate a new CD19 directed CAR-T therapy manufactured locally with the goals to expedite infusion to wider patient inclusion that includes those who were previously excluded, such as pediatric patients with B-cell NHL and patients in primary relapse.",[27,279],"B-cell Non Hodgkin Lymphoma",[95,281,63,282,283,120,284,285],"CAR-T","relapsed","refractory","B-NHL","Miltenyi CliniMACS Prodigy","2026-04-16",{"date":288,"type":32},"2026-04-20",{"date":290,"type":32},"2021-03-10",{"date":292,"type":21},"2026-07",{"name":294,"class":39},"University of Colorado, Denver",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":314,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":328},"100532125","phase-1-clic-2201-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100532125","NCT06208735","CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria in Cohort A:\n\nParticipants must meet the following criteria to be enrolled on the trial:\n\n1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.\n2. Participants must provide written informed consent.\n3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:\n\n   1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),\n   2. high grade B cell lymphoma NOS,\n   3. high grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements,\n   4. primary mediastinal large B-cell lymphoma (PMBCL),\n   5. aggressive B cell lymphoma transformed from an indolent lymphoma,\n   6. mantle cell lymphoma (MCL),\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥40%,\n   2. Creatinine clearance using Cockcroft-Gault of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.\n7. Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n8. Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.\n\nInclusion Criteria in Cohort B:\n\n1. Participants in the cohort B must be between 1-39 years of age at the time of consent.\n2. For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent\u002Fconsent must be obtained (if applicable).\n3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants in cohort B and\u002For those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable).\n6. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥45%,\n   2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n7. Participants must have a Karnofsky or Lansky Score ≥50%.\n8. Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n9. Participants must be willing to undergo a bone marrow biopsy at enrolment.\n\nExclusion Criteria:\n\n1. Any uncontrolled or serious active infection at the time of enrolment.\n2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.\n3. Live vaccine ≤6 weeks prior to enrolment\n4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.\n5. Diagnosis of primary central nervous system lymphoma (PCNSL)\n6. Treatment with any of the following in the specified time period before leukapheresis:\n\n   1. Allogeneic HCT within 3 months,\n   2. Autologous HCT within 3 months,\n   3. CD19 CAR-T cell infusion within 3 months,\n   4. Donor lymphocyte infusion (DLI) within 3 months,\n   5. Bendamustine within the last 6 months,\n   6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),\n   7. Systemic administration of therapeutic dose corticosteroids (\\>20 mg\u002Fday prednisone or equivalent for adults and ≥ 12 mg\u002Fm2\u002Fday for paediatric participants) within 7 days prior to leukapheresis.\n   8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.\n   9. Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.\n7. Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n8. Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.\n9. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.\n10. Any Human Immunodeficiency Virus (HIV) infection at time of screening.\n11. Hypersensitivity to fludarabine or cyclophosphamide.\n12. Any allergy to gentamycin or its derivatives\n13. Participants who do not meet the minimum weight requirement for the planned dose level.\n14. Pregnant or nursing participants.",{"count":303,"type":21},24,[24],"This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed\u002Frefractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion.\n\nThe primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies.\n\nThe secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201.\n\nExploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.",[307,308,27,309,310,311,312,313],"B-Cell Leukemia","Non-Hodgkin's Lymphoma","Diffuse Large B Cell Lymphoma","High-grade B-cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Mantle Cell Lymphoma","B-cell Lymphoma",[315,316,96,317,318],"Chimeric Antigen Receptor T cells","CLIC-2201","Immunotherapy","CAR-T cell","2026-03-30",{"date":321,"type":32},"2026-04-03",{"date":323,"type":32},"2025-01-02",{"date":325,"type":21},"2027-08-01",{"name":327,"class":39},"British Columbia Cancer Agency",7,{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":336,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":350,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":362},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":339,"type":21},32,[24,88],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[27,343,344,345,346,347,312,309,310,210,311,348,349],"Large B-cell Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[351,352,353],"CD19-positive","Leukemia","Lymphoma","2026-03-24",{"date":319,"type":32},{"date":357,"type":32},"2025-05-30",{"date":359,"type":21},"2031-09",{"name":361,"class":75},"Vironexis Biotherapeutics Inc.",9,{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":40},"100491057","phase-1-co-administration-of-cart22-65s-and-hucart19-for-b-all-100491057","NCT05674175","Co-administration of CART22-65s and huCART19 for B-ALL","Use of Autologous Anti-CD22 CAR T Cells (CART22-65s) Co-administered With Humanized Anti-CD19 CAR T Cells (huCART19) in Children and Young Adults With Relapsed or Refractory B-ALL","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Patients with documented CD19+ and\u002For CD22+ ALL\u002FLLy:\n\n   1. Cohort A: Patients with relapsed or refractory ALL\u002FLLy:\n   2. Cohort B: Patients with poor response to prior B cell directed engineered cell therapy\n3. Patients with prior or current history of Central Nervous System 3 disease will be eligible if Central Nervous System disease is responsive to therapy\n4. Documentation of CD19 and\u002For CD22 tumor expression in bone marrow, peripheral blood, Cerebrospinal fluid, or tumor tissue by flow cytometry at the time of last detectable disease. If the patient has experienced a relapse after CD19-directed and\u002For CD22-directed therapy, flow cytometry should be evaluated after this therapy to demonstrate CD19 and\u002For CD22 expression.\n5. Age 0-29 years\n6. Adequate organ function\n7. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50.\n8. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n1. Active hepatitis B or active hepatitis C\n2. HIV infection\n3. Active acute or chronic Graft Vs. Host Disease requiring systemic therapy\n4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.\n5. Central nervous system disease that is progressive on therapy, or with Central nervous system parenchymal lesions that might increase the risk of central nervous system toxicity.\n6. Pregnant or nursing (lactating) women\n7. Uncontrolled active infection","29 Years",{"count":372,"type":21},93,[24,88],"This study will evaluate the safety and efficacy of administering two CAR T cell products, huCART19 and CART22-65s, in children with advanced B cell Acute Lymphoblastic Leukemia (B-ALL).",[27,376],"B Lineage Lymphoblastic Lymphoma",{"date":378,"type":32},"2026-03-27",{"date":380,"type":32},"2023-01-25",{"date":382,"type":21},"2029-07-01",{"name":384,"class":39},"Stephan Grupp MD PhD",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":22,"phases":395,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":40},"100542455","clinical-trial-of-cd19-and-cd22-car-sequential-therapy-versus-single-cd19-car-bridging-to-hsct-for-rr-b-all-patients-100542455","NCT06343090","Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r\u002Fr B-ALL Patients","Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Only patients who meet all the following criteria can be included in the group:\n\n  1. Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow lymphoblasts on hematopathology review of bone marrow aspirate and biopsy materials, which were confirmed by comprehensive flow cytometric immunophenotyping, minimal residual disease analysis and karyotyping of G-banded metaphase chromosomes). Molecular characterization could be obtained via interphase fluorescence in situ hybridization (FISH) testing, reverse transcriptase polymerase chain reaction (RT-PCR) testing, comprehensive testing by next-generation sequencing (NGS) for gene fusions and pathogenic mutations, etc. Determination of the World Health Organization ALL subtypes and cytogenetic and clinical risk groups were also allowed. B-ALL patients who did not achieve a complete remission after previous therapy (including the various treatment response scenarios shown in Table 1), who did not achieve a complete remission after at least two lines of TKI agents (including the various treatment response scenarios shown in Table 1), or who had ≥1 relapses were defined as having refractory or relapsed disease. Patients who were diagnosed as CD19- and CD22-positive high-risk B-ALL with continuous positive minimal residual disease (MRD) for more than three months after last therapy were also eligible. Patients had positive CD19 and CD22 expression on leukemia blasts by FCM (\\>80% CD19 and CD22 positive);\n  2. Age from 1 to 70 years old;\n  3. No serious allergic constitution;\n  4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;\n  5. Have life expectancy of at least 60 days based on investigator's judgement;\n  6. Voluntary informed consent is signed by self-aware patients aged 8-70 years and by legal representatives (guardians) of pediatric patients under 18 years of age.\n\nExclusion Criteria:\n\n* Patients with at least one of the following conditions are excluded:\n\n  1. Intracranial hypertension or unconscious;\n  2. Acute heart failure or severe arrhythmia;\n  3. Acute respiratory failure;\n  4. Other types of malignant tumors;\n  5. Diffuse intravascular coagulation;\n  6. Serum creatinine and\u002For blood urea nitrogen over 1.5 times the normal value;\n  7. Sepsis or other uncontrolled infection;\n  8. Uncontrolled diabetes mellitus;\n  9. Severe psychological disorder;\n  10. Obvious cranial lesions by cranial MRI;\n  11. More than 20 leukemic cells\u002FμL in cerebrospinal fluid;\n  12. More than 30% leukemic cells in the peripheral blood;\n  13. Organ recipients;\n  14. Pregnant or breastfeeding;\n  15. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).","70 Years",{"count":394,"type":21},353,[396],"NA","This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r\u002Fr B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r\u002Fr B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r\u002Fr B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.",[27,399,400],"Acute Lymphoblastic Leukemia, in Relapse","Refractory Acute Lymphoid Leukemia","2026-03-06",{"date":403,"type":32},"2026-03-10",{"date":405,"type":32},"2024-04-12",{"date":407,"type":21},"2043-09-30",{"name":409,"class":39},"Beijing GoBroad Hospital",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":18,"enrollmentInfo":417,"targetDuration":4,"studyType":22,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":40},"100541142","phase-1-safety-tolerability-and-pharmacokinetics-of-donor-derived-cd19-car-therapy-bridged-allo-hsct-and-sequential-donor-derived-cd22-car-therapy-for-rr-b-all-a-clinical-trial-100541142","NCT06326008","Safety, Tolerability, and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allo-HSCT and Sequential Donor-derived CD22 CAR Therapy for r\u002Fr B-ALL: a Clinical Trial","Safety, Tolerability and Pharmacokinetics of Donor-derived CD19 CAR Therapy Bridged Allogeneic Haematopoietic Stem Cell Transplantation and Sequential Donor-derived CD22 CAR Therapy in Refractory or Relapsed B Cell Acute Lymphoblastic Leukemia: a Clinical Trial","Inclusion Criteria:\n\n\\- Patients will be enrolled only if they meet all the inclusion criteria.\n\n1. Patients with relapsed or refractory CD19+\u002FCD22+ (FCM \\>95%) B-cell acute lymphoblastic leukaemia who have progressed despite or are intolerant to all standard therapies, including, but not limited to, immunotherapies such as Blinatumomab (BITE), Tyrosine kinase inhibitors (TKI), CAR T-cell therapy, etc.; Currently available therapies have a limited prognosis and there are no available curative treatment options (e.g., HSCT or chemotherapy);\n2. Peripheral blood tumour burden ≥60% or severe peripheral blood cytopenia, unsuitable\u002Funable to collect autologous lymphocytes;\n3. 1 to 18 years old;\n4. Patient's expected survival time ≥ 60 days;\n5. Physical status: ECOG score 0-2;\n6. Availability of allogeneic donors (HLA-identical or HLA-haploidentical) DSA-negative for collection of peripheral blood mononuclear cells and peripheral blood stem cells;\n7. Sign an informed consent form during the screening period. Pediatric patients under 8\\~18 years of age need to have sufficient awareness to voluntarily sign an informed consent form, and their legal representatives (guardians) also need to voluntarily sign an informed consent form; pediatric patients aged 1\\~7 years can only be recruited after their legal guardians have voluntarily signed an informed consent form.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria are not eligible for enrolment.\n\n  1. Patients who have received previous haematopoietic stem cell transplantation (including peripheral blood haematopoietic stem cell transplantation and bone marrow haematopoietic stem cell transplantation);\n  2. Intracranial hypertension or cerebral impaired consciousness;\n  3. Symptomatic heart failure or severe cardiac arrhythmia;\n  4. Symptoms of severe respiratory failure;\n  5. With other types of malignant tumours;\n  6. Diffuse intravascular coagulation;\n  7. Serum creatinine and\u002For urea nitrogen ≥ 1.5 times the normal value;\n  8. Suffering from sepsis or other uncontrollable infections;\n  9. Suffering from uncontrollable diabetes mellitus;\n  10. Severe mental disorders;\n  11. Have significant intracranial lesions on cranial MRI (excluding intracranial masses caused by central nervous system leukaemia);\n  12. Have organ transplant history;\n  13. Female patients (patients of childbearing potential) with positive blood HCG test;\n  14. Hepatitis (including Hepatitis B and Hepatitis C) and positive screening for AIDS and syphilis;\n  15. No allogeneic donor suitable for collection of peripheral blood lymphocytes and haematopoietic stem cells.",{"count":418,"type":21},48,[24],"This is an investigator-initiated, single-arm, open-label, non-randomised phase I clinical study. The objective of this trial is to evaluate the safety, tolerability and pharmacokinetics of donor-derived CD19 CAR Therapy bridged Allo-HSCT and sequential donor-derived CD22 CAR Therapy for r\u002Fr B-ALL and to explore the efficacy of this therapy preliminarily. The primary endpoints are incidence and type of dose-limiting toxicity (DLT) within 28 days (i.e., 43 days after donor-derived CD19 CAR T-cell infusion) after donor-derived CD19 CAR T-cell therapy bridged allogeneic haematopoietic stem cell transplantation; total number, incidence and severity of adverse events from donor-derived CD19 CAR T cell infusion back to 30 days after donor-derived CD22 CAR T cell infusion (i.e., within 120 days of donor-derived CD19 CAR T cell infusion). The secondary endpoints are total number, incidence and severity of adverse events from 120 days to 2 years after donor-derived CD19 CAR T-cell infusion; ORR(CR+CRi) on days 45, 90, 120; duration of response(DOR), event-free survival(EFS), overall survival(OS); pharmacokinetics characteristics. The trial plan to enroll 3\\~12 cases in dose escalation phase and 36 cases in dose expansion phase.",[27,399],"2026-03-05",{"date":424,"type":32},"2026-03-09",{"date":426,"type":21},"2026-03-15",{"date":428,"type":21},"2026-12-30",{"name":409,"class":39},{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":40},"100546005","cik-cell-therapy-for-relapsed-or-refractory-acute-b-lymphoblastic-leukemia-prognostic-impact-on-patients-with-early-car-t-cell-dysfunction-100546005","NCT06389305","CIK Cell Therapy for Relapsed or Refractory Acute B-Lymphoblastic Leukemia: Prognostic Impact on Patients With Early CAR-T Cell Dysfunction","Cytokine-induced Killer(CIK) Cell Therapy and Its Impact on Early Functional Exhaustion of Chimeric Antigen Receptor-T(CAR-T) Cells in Relapsed or Refractory Acute B-Lymphoblastic Leukemia: A Prospective Study","Inclusion Criteria:\n\n* A patient must meet all of the following to be enrolled:\n\n  1. A confirmed diagnosis of refractory or relapsed B-ALL (criteria reference: NCCN, 2024.4), where all patients meet the National Comprehensive Cancer Network(NCCN) guidelines for the diagnosis of acute lymphoblastic leukemia (hematopathological examination of bone marrow aspirate and biopsy tissue showing ≥20% lymphoblasts in the bone marrow, confirmed by comprehensive flow cytometry (FCM) immunotyping, minimal residual disease analysis, and G-banded metaphase chromosome karyotype analysis). Molecular characteristics can be described through methods such as interphase fluorescence in situ hybridization (FISH) testing, reverse transcription polymerase chain reaction (RT-PCR) testing, and next-generation sequencing (NGS) for comprehensive detection of fusion genes and pathogenic mutations. Determination can also be made by the World Health Organization's subtypes of acute lymphoblastic leukemia, as well as cytogenetic and clinical risk groups.\n  2. Loss of CAR-T cell activity within 6 months after previous CAR-T therapy and no relapse.\n  3. Age between 1 and 39 years old.\n  4. No severe allergic constitution.\n  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n  6. Life expectancy, as judged by the investigator, of at least 60 days.\n  7. Patients with self-awareness between 8 and 39 years of age voluntarily sign an informed consent, and the legal representative (guardians) of child patients under 18 years of age voluntarily signs an informed consent.\n\nExclusion Criteria:\n\n* A patient with at least one of the following conditions will be excluded:\n\n  1. Received bendamustine treatment within the past 9 months;\n  2. Intracranial hypertension or impaired consciousness in the brain;\n  3. Symptomatic heart failure or severe arrhythmia;\n  4. Symptoms of severe respiratory failure;\n  5. With other types of malignant tumors;\n  6. Disseminated intravascular coagulation;\n  7. Serum creatinine and\u002For blood urea nitrogen ≥ 1.5 times the normal value;\n  8. Suffering from sepsis or other uncontrollable infections;\n  9. Uncontrollable diabetes;\n  10. Severe mental disorders;\n  11. Significant lesions in the brain as detected by head magnetic resonance imaging;\n  12. Leukemic cells in the cerebrospinal fluid \\>20 cells\u002FμL;\n  13. Peripheral blood leukemic cell proportion \\>30%;\n  14. Have undergone organ transplantation;\n  15. Female patients (those with childbearing potential) are pregnant or lactating;\n  16. Active or uncontrollable infectious diseases, such as hepatitis (HBV, HCV), HIV, or syphilis.","39 Years",{"count":439,"type":21},213,[396],"This is a single-center, double-blind, randomized trial. Patients with relapsed or refractory acute B-lymphoblastic leukemia(r\u002Fr B-ALL) experiencing early functional exhaustion of CAR-T cells will be randomly allocated into three groups: the control cell group, the CIK treatment group, and the messenger RNA(mRNA)-CIK treatment group. The primary objective of the study is to evaluate the prognostic impact of CIK cell therapy on the early functional exhaustion of CAR-T cells in children and adolescent and young adult (AYA) with r\u002Fr B-ALL. The primary endpoint of the study is the event-free survival rate of these patient in the CIK cell therapy group.A total number of 213 subjects will be enrolled.",[27,399,400],"2026-02-24",{"date":445,"type":32},"2026-02-25",{"date":447,"type":32},"2024-05-27",{"date":449,"type":21},"2026-05-30",{"name":409,"class":39},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":459,"enrollmentInfo":460,"targetDuration":4,"studyType":462,"phases":4,"briefSummary":463,"conditions":464,"keywords":472,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":482,"locationsCount":484},"100625415","a-multi-site-study-to-evaluate-the-persistence-of-protective-immunity-to-routine-childhood-vaccinations-in-participants-with-b-allly-who-have-received-blinatumomab-100625415","NCT07422337","A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL\u002FLy Who Have Received Blinatumomab","Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination","BOOSTER","Inclusion Criteria:\n\n* Diagnosis of B-lineage acute lymphoblastic leukemia\u002Flymphoma\n* ≥1 year old and up to 21 years old at diagnosis\n* Informed consent provided, and if applicable, child assent provided\n* Must have received all vaccinations routinely administered during first year of life\n\nExclusion Criteria:\n\n* Relapsed\u002Frefractory disease at any time\n* Received or will require a bone marrow transplant and\u002For cellular therapy\n* Pregnancy","23 Years",{"count":461,"type":21},300,"OBSERVATIONAL","The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia\u002FLymphoma. The main study aims are:\n\n* Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL\u002FLy who have received blinatumomab.\n* To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.\n\nResearchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.",[465,466,467,468,469,27,470,471],"B-Cell ALL","B-Cell Acute Lymphoblastic Leukaemia","B-Cell Lymphoblastic Leukemia","B-Cell Lymphoblastic Leukemia\u002FLymphoma","B-cell Acute Lymphoblastic Leukemia (B-ALL)","B-cell Childhood Acute Lymphoblastic Leukemia","B-cell Leukemia",[473,474,475,476],"vaccines","cancer","blinatumomab","immunotherapy","2026-02-23",{"date":445,"type":32},{"date":480,"type":32},"2026-01-13",{"date":154,"type":21},{"name":483,"class":39},"Arkansas Children's Hospital Research Institute",2,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":497,"conditions":498,"keywords":499,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":40},"100625963","early-phase-1-clinical-study-of-syncar-100-in-the-treatment-of-relapsedrefractory-acute-b-lymphoblastic-leukemia-100625963","NCT07429461","Clinical Study of SYNCAR-100 in the Treatment of Relapsed\u002FRefractory Acute B-Lymphoblastic Leukemia","Early Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SYNCAR-100 in the Treatment of CD19-Positive Relapsed or Refractory Acute B-Lymphoblastic Leukemia (R\u002FR B-ALL)","Inclusion Criteria:\n\n* 1.Aged 18 to 75 years (inclusive), of any gender.\n* 2.Karnofsky Performance Status score ≥ 70.\n* 3.Estimated life expectancy ≥ 12 weeks.\n* 4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.\n* 5.Confirmed diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) by bone marrow examination, and meeting one of the following criteria:\n* ① Refractory B-ALL: Failure to achieve complete remission (CR) after 2 courses of standard induction chemotherapy, or failure to achieve CR after first-line\u002Fmultiline salvage chemotherapy.\n* ② Relapsed B-ALL: Relapse within 12 months after the first remission, or relapse after first-line\u002Fmultiline salvage chemotherapy.\n* ③Relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT).\n* ④ For Philadelphia chromosome-positive (Ph+) patients: At least 2 lines of tyrosine kinase inhibitor (TKI) therapy have failed, or the patient is intolerant to TKI therapy, or the patient harbors the T315I mutation and is resistant to TKIs.\n* 6.Proportion of blasts and immature lymphocytes in bone marrow \\> 5% confirmed by bone marrow morphologic examination.\n* 7.No prior hematopoietic stem cell transplantation (HSCT) within 6 months before enrollment.\n* 8.Adequate organ function reserve, as defined by all of the following:\n* ① Creatinine clearance (calculated by the Cockcroft-Gault formula) \\> 60 mL\u002Fmin: Male: Creatinine Clearance = \\[(140 - Age) × Body Weight (kg)\\] \u002F \\[0.818 × Serum Creatinine (μmol\u002FL)\\] Female: Creatinine Clearance = \\[(140 - Age) × Body Weight (kg) × 0.85\\] \u002F \\[0.818 × Serum Creatinine (μmol\u002FL)\\]\n* ② Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 times the upper limit of normal (ULN) ; for patients with hepatic metastasis, AST and ALT ≤ 5 times the upper limit of normal (ULN) .\n* ③Serum total bilirubin \\\u003C 1.5 times the upper limit of normal (ULN) ; for patients with Gilbert's syndrome, total bilirubin ≤ 3 times the upper limit of normal (ULN) .\n* ④ Absolute lymphocyte count (ALC) ≥ 0.1 × 10\\^9\u002FL.\n* ⑤Left ventricular ejection fraction (LVEF) \\> 50% confirmed by echocardiography, with no clinically significant pericardial effusion on echocardiography.\n* ⑥ No clinically significant pleural effusion.\n* ⑦ Baseline peripheral oxygen saturation (measured at the fingertip) \\> 92% while breathing room air.\n* 9.For women of childbearing potential: Non-lactating; negative result of highly sensitive serum or urine pregnancy test during screening. All women of childbearing potential must use medically accepted contraceptive methods (e.g., intrauterine device, oral contraceptives) throughout the treatment period and for 2 years after the first treatment. For males of childbearing potential: Sperm donation is prohibited during the same period.\n* 10.Ability to communicate effectively with investigators; willingness and ability to comply with the study protocol, complete all study-related procedures as required, and provide written informed consent (signed voluntarily by the patient or their legal guardian).\n\nExclusion Criteria:\n\n* 1.Isolated extramedullary leukemia or isolated extramedullary relapse.\n* 2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.\n* 3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignant tumors with disease-free survival for more than 5 years.\n* 4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.\n* 5.Administration of live or attenuated live vaccines within 4 weeks prior to enrollment.\n* 6.Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) with tyrosine kinase inhibitor (TKI) therapy within 1 week prior to enrollment.\n* 7.Prior receipt of CD19-targeted therapy, CAR-T cell therapy, or other gene-edited T cell therapy.\n* 8.Grade ≥2 acute graft-versus-host disease (GVHD) (per Glucksberg criteria) requiring treatment, or extensive chronic GVHD (per Seattle criteria) within 4 weeks prior to enrollment; or patients judged by the investigator to potentially require anti-GVHD therapy during the study period.\n* 9.Comorbidities judged by the investigator to require systemic corticosteroid therapy or other immunosuppressive therapy during the study period; or receipt of allogeneic cellular therapy (e.g., donor lymphocyte infusion \\[DLI\\]) within 4 weeks prior to enrollment.\n* 10.Receipt of CNS-directed radiotherapy within 4 weeks prior to enrollment.\n* 11.Unresolved acute toxicities from prior therapy (excluding hematologic toxicities and alopecia) that have not recovered to Grade 1 or lower.\n* 12.Known life-threatening hypersensitivity or other intolerance to the study drug, or a history of severe atopy.\n* 13.Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto's thyroiditis, etc.), excluding hypothyroidism that is controllable solely with hormone replacement therapy.\n* 14.Receipt of major surgery requiring general anesthesia within 4 weeks prior to enrollment; or failure to recover and achieve clinical stability from prior surgical treatment; or anticipated major surgery requiring general anesthesia during the study period.\n* 15.Use of other investigational drugs within 28 days prior to enrollment.\n* 16.A history of any unstable cardiovascular disease within 6 months prior to enrollment, including but not limited to unstable angina pectoris, myocardial infarction, heart failure (New York Heart Association \\[NYHA\\] Class ≥III), severe cardiac arrhythmias requiring pharmacologic treatment; or receipt of percutaneous transluminal coronary angioplasty, coronary stenting, or coronary artery bypass grafting within 6 months prior to enrollment.\n* 17.A history of central nervous system (CNS) disease or disorders (e.g., seizure disorders, cerebral vascular ischemia\u002Fhemorrhage, dementia, cerebellar disease) or any autoimmune disease involving the CNS.\n* 18.Uncontrolled active infection at screening (e.g., sepsis, bacteremia, fungemia, viremia).\n* 19.Any other condition judged by the investigator to make the patient unsuitable for participation in this clinical study.","75 Years",{"count":494,"type":21},16,[496],"EARLY_PHASE1","The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R\u002FR B-ALL). Participants who have signed the informed consent form will undergo screening against the inclusion and exclusion criteria. Eligible participants will receive study drug administration once weekly for a total of four doses, followed by a 1-year safety and efficacy follow-up observation period. After the completion of the study, long-term follow-up may be required for participants to monitor their health and survival status until 15 years post-treatment, or until the occurrence of patient death, loss to follow-up, or withdrawal of consent.",[92],[92,500,501,502,503,504,505,506],"Relapsed Refractory Leukemia","CD19 Antigens","Chimeric Antigen Receptor T-Cells","circRNA","Nucleic Acids","Drug Safety","Clinical Study","2026-02-22",{"date":443,"type":32},{"date":510,"type":21},"2026-02-28",{"date":512,"type":21},"2041-12-31",{"name":514,"class":39},"Zhejiang University",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":437,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":40},"100582434","phase-1-study-of-inotuzumab-ozogamicin-venetoclax-and-dexamethasone-for-relapsed-b-cell-all-100582434","NCT06863259","Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL","A Phase 1 Study With a Pilot Expansion Phase of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) for Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\nDiagnosis:\n\n\\- Patients must have relapsed B-ALL \\> 5 % bone marrow blasts with or without extramedullary disease.\n\n* At least 20% of leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by flow cytometry of a bone marrow aspirate. In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be obtained due to patient clinical status, then flow cytometry of peripheral blood specimens may be substituted if the patient has \\> 1,000\u002FµL circulating blasts. Alternatively, CD22 expression may be documented by immunohistochemistry of a relapse bone marrow biopsy specimen.\n* Patients with one of the following:\n\n  * 2nd or greater relapse OR first relapse less than 24 months from diagnosis OR first or greater relapse in patients over 18.\n  * Primary refractory disease: defined as \\> 1% bone marrow blasts by flow MRD after at least 2 courses of frontline chemotherapy. Patients who receive 2 courses of chemotherapy and 1 course of blinatumomab are also eligible, but no further treatment attempts beyond that are permitted.\n  * Any relapse after HSCT or CAR-T therapy.\n* Patients with Ph+ ALL must have had at least two prior therapy attempts and failed all available tyrosine kinase inhibitors.\n\nPrior Therapy:\n\n\\- Cytotoxic chemotherapy:\n\n• At least 14 days must have elapsed from the completion of systemic cytotoxic therapy that is known to be myelosuppressive with the exception of hydroxyurea for cytoreduction OR conventional maintenance chemotherapy (i.e., corticosteroids, vincristine, 6MP, and\u002For oral methotrexate) for patient who relapse while on maintenance therapy OR lumbar puncture with intrathecal chemotherapy. Corticosteroids, vincristine, 6MP, and\u002For oral methotrexate must be discontinued at least 24 hours prior to the start of protocol therapy. If corticosteroids were used to modify immune adverse events of prior therapy rather than as chemotherapy, at least 14 days must have elapsed since the last dose.\n\nSystemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy. For all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement\u002Fstress dosing of hydrocortisone for documented adrenal insufficiency.\n\nAt least seven days must have elapsed from the administration of anti-cancer agents not known to be myelosuppressive.\n\n* Anti-cancer agents that are antibodies\n\n  • At least 21 days must have elapsed from infusion of last dose of antibody. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days.\n* Radiation therapy\n\n  • At least 14 days must have elapsed since local palliative radiotherapy. At least 3 months must have elapsed if patient received cranial or craniospinal radiotherapy, if more than 50% of the pelvis was irradiated, or if total body irradiation was received. If other substantial bone marrow irradiation was given, at least 6 weeks must have elapsed.\n* Hematopoietic stem cell transplant\n\n  • At least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patients must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease and must be off all immunosuppressive medications for at least 28 days.\n* Chimeric antigen receptor T-cell therapy\n\n  • At least 30 days must have elapsed from the last CAR-T cell infusion. Patients may have previously received CD19 or CD22 directed CAR-T cell therapy but must still have CD22 expression on at least 20% of leukemic blasts.\n* Prior Inotuzumab ozogamicin Patients with prior InO exposure must have received no more than 2.1 mg\u002Fm2 of prior InO and be at least 90 days from last dose.\n* Prior Venetoclax exposure • Patients with prior venetoclax exposure are eligible provided they are at least 30 days from last dose.\n\nAge:\n\n\\- Patients must be ≥ 1 year and ≤ 39.99 years of age at enrollment.\n\nPerformance status:\n\n\\- Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nOrgan function requirements:\n\n* Adequate Renal Function Defined As:\n\n  • An estimated GFR of 50 mL\u002Fmin\u002F1.73m2 as determined by the Levey formula (see appendix C), cystatin C, or radioisotope determination.\n* Adequate Liver Function Defined As:\n\n  * Direct bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.\n  * SGPT (ALT) \\\u003C 2.5 x the age-appropriate upper limit of normal (ULN) per local lab (unless elevation is related to leukemia involvement).\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\nExclusion Criteria:\n\n* Patients with any prior history of SOS irrespective of severity.\n* Patients with isolated CNS, testicular, or any other isolated extramedullary site of relapse.\n* Patients with CNS3 disease at time of enrollment regardless of marrow involvement.\n\nConcomitant Medications:\n\n* Investigational drugs: patients who are currently receiving another investigational drug.\n* Anti-cancer agents: Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy).\n* Anti-GVHD or agents to prevent organ rejection post-transplant. Patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft vs host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. At least 3 half-lives must have relapsed after the last dose of GVHD or anti-rejection medications.\n* Patients \\> 10 kg AND \\> 24months may receive azole antifungals (See altered venetoclax dosing provided for patients on azoles).\n\nInfection:\n\n* Patients with known HIV, hepatitis B or C infections. Testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient.\n* Patients who have an active uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment.\n  * Fever above 38.2℃ within 48 hours of study enrollment with documented infection Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection.\n  * Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with C. difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed, and stools must have normalized to baseline.\n  * Active viral or protozoal infection requiring IV treatment.\n* Patients known to have one of the following concomitant genetic syndromes: Blood syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachmann-Diamond syndrome, or any other known bone marrow failure syndrome.\n\nPregnancy and Breastfeeding:\n\n* There have been no human studies of inotuzumab ozogamicin or venetoclax in pregnant women. Based on safety studies, both agents have the potential to impair human male and female fertility to adversely affect human embryo-fetal development. Women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin and venetoclax. There is no known information regarding the presence of inotuzumab ozogamicin or venetoclax in human milk, the effects on the breast-fed infant, or the effect on milk production. Women should not breast-feed during treatment with inotuzumab ozogamicin or venetoclax and for at least 2 months after the final dose. Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment.\n* Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin or venetoclax.\n* Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and venetoclax and for at least 5 months after the last dose of inotuzumab ozogamicin and venetoclax.\n* Lactating females are not eligible unless they agree not to breastfeed their infants.\n\n  * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) with the exception of alopecia.\n  * History of allergic reactions attributed to compounds of similar chemical or biologic composition to venetoclax or inotuzumab ozogamicin.",{"count":523,"type":21},28,[24],"The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are:\n\nIs the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients?\n\nWhat medical problems do patients taking IoVeX experience?\n\nParticipants will:\n\nReceive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days.\n\nHave checkups and tests at the beginning of the study and throughout the course of each cycle.",[27],[528,120,27],"Relapsed","2026-02-16",{"date":531,"type":32},"2026-02-18",{"date":533,"type":32},"2025-05-21",{"date":535,"type":21},"2029-01-01",{"name":537,"class":39},"Children's Hospital Medical Center, Cincinnati",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":545,"targetDuration":4,"studyType":22,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":559},"100560680","phase-1-study-of-yk012-in-b-cell-acute-lymphoblastic-leukemia-100560680","NCT06580301","Study of YK012 in B-cell Acute Lymphoblastic Leukemia","An Open-Label, Multi-Center, Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.\n2. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.\n3. An estimated survival time of more than 12 weeks.\n4. A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:\n\n   1. Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT).\n   2. Ph-positive B-ALL: failure to 1 or more tyrosine kinase inhibitors (TKIs), or intolerance to treatment with TKIs, or with the T315I mutation.\n5. ≥ 5% blasts in the bone marrow by morphologic assessment.\n6. Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.\n7. Adequate hematological and organ function.\n8. Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.\n9. Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Burkitt´s Leukemia according to World Health Organization (WHO) classification.\n2. History of antitumor therapy as follows, before the first dose of study drug:\n\n   1. Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer\n   2. Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks\n   3. Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional\u002Fpatent medicine that has definite antitumor effect within 2 weeks\n   4. Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter\n   5. Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks\n   6. Autologous stem cell transplantation within 6 weeks\n   7. History of organ transplant, or allogeneic stem cell transplantation within 12 weeks.\n3. Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment.\n4. Other malignancy within 5 years, except localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.\n5. Active central nervous system (CNS) involvement or meningeal involvement with clinical signs, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.\n6. a. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. b. Evidence for presence of inflammatory lesions and\u002For vasculitis on cerebral MRI.\n7. History or evidence of cardiovascular disease, including:\n\n   1. Acute coronary syndromes (e.g., myocardial infarction, unstable angina)\n   2. Coronary angioplasty or stenting within 6 months prior to enrollment\n   3. Clinically significant unstable arrhythmias (e.g., atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YK012 were allowed\n   4. New York Heart Association (NYHA) stage III or higher congestive heart failure\n   5. Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\\\u003C50% if there is no lower limit at the study center\n   6. The Fridericia-corrected QT interval (QTcF, mean of triplicate measurements) ≥ 470 msec (female) or ≥ 450 msec (male)\n   7. Implantable defibrillator\n   8. Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and\u002For DBP≥100 mm Hg).\n8. Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.\n9. History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening.\n10. Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not recovered to Grade ≤1 or baseline graded by CTCAE v5.0 before the first dose of the YK012.\n11. Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg\u002Fday or equivalent during the trial, or any other immunosuppressive therapy within 4 weeks prior to study entry.\n12. Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and\u002For hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)\\>ULN of the testing agency; Hepatitis C antibody (HCV-Ab) positive and hepatitis C virus-RNA (HCV-RNA)\\>ULN of the testing agency; Anti-human immunodeficiency virus (Anti-HIV) positive. Participants will be excluded from the study if any of the above criteria is met.\n13. Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.\n14. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).\n15. Pregnant or lactating women.\n16. Known mental disorder that may affect study compliance or poor compliance.\n17. Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating in the study.",{"count":546,"type":21},46,[24,88],"The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).",[27],"2026-02-04",{"date":552,"type":32},"2026-02-06",{"date":554,"type":32},"2024-09-25",{"date":556,"type":21},"2027-06-30",{"name":558,"class":75},"Excyte Biopharma Ltd",12,{"id":561,"slug":562,"hasResults":12,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":22,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":582},"100336867","phase-1-dose-escalation-and-dose-expansion-study-of-safety-of-azer-cel-pbcar0191-in-participants-with-relapsedrefractory-rr-non-hodgkin-lymphoma-nhl-and-rr-b-cell-acute-lymphoblastic-leukemia-b-all-100336867","NCT03666000","Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed\u002FRefractory (r\u002Fr) Non-Hodgkin Lymphoma (NHL) and r\u002Fr B-cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 1\u002F1b, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate Safety and Clinical Activity of PBCAR0191 (Azercabtagene Zapreleucel or \"Azer-cel\") in Subjects With Relapsed\u002FRefractory (r\u002Fr) Non-Hodgkin Lymphoma (NHL) and r\u002Fr B-cell Acute Lymphoblastic Leukemia (B-ALL)","Key Inclusion Criteria\n\nCriteria for B-ALL:\n\n• Participant has confirmed unequivocal r\u002Fr CD19+ B-ALL.\n\nCriteria for NHL and CLL\u002FSLL:\n\n• Participant has unequivocal aggressive CD19+ r\u002Fr B-cell NHL that is confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy.\n\nFor Phase 1 Dose Escalation:\n\n* Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation\n* Follicular lymphoma (FL) including Grade 3 or transformed FL\n* High-grade B-cell lymphoma (HGBCL)\n* Primary mediastinal lymphoma\n\nFor Phase 1b Dose Expansion (CAR T-relapsed cohort):\n\n* DLBCL not otherwise specified (NOS)\n* HGBCL\n* DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone lymphoma \\[MZL\\], and Waldenstrom's Macroglobulinemia \\[WM\\])\n* Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the Medical Monitor.\n* Participants previously treated with CD19-directed autologous CAR T therapies have received no more than 2 lines of therapy after administration of their previous CAR T product.\n* For the expansion CAR T-relapsed cohort only: Participants must have received autologous CD19-directed CAR T therapy and demonstrated clinical response to the treatment at Day 28 or later, followed by relapse or progression.\n\nFor Phase 1b dose expansion (CAR T-naive cohort):\n\n* DLBCL NOS\n* DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)\n* HGBCL\n* FL (Grade 1-3a)\n* MZL that is fluorodeoxyglucose (FDG)-avid on positron emission tomography (PET) scan\n* WM\n* CLL\u002FSLL\n* Primary central nervous system (CNS) lymphoma (PCNSL)\n* Other LBCL subtypes may be enrolled with approval from the Medical Monitor.\n* Participant must have received at least 1-2 prior lines of therapy, depending on histological subtype but no more than 7 systemic lines of anti-cancer therapy.\n\nCriteria for both B-ALL, NHL, and CLL\u002FSLL:\n\n* Eastern Cooperative Oncology Group performance status score of 0 or 1.\n* An estimated life expectancy of at least 12 weeks according to the investigator's judgment.\n* Seronegative for human immunodeficiency virus antibody.\n* Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac function.\n\nKey Exclusion Criteria\n\nCriteria for B-ALL:\n\n• Burkitt cell (L3 ALL) or mixed-lineage acute leukemia.\n\nCriteria for NHL:\n\n* Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.\n* Active hemolytic anemia.\n\nCriteria for B-ALL and NHL:\n\n* No active CNS disease, excluding PCNSL\n* History of another primary malignancy\n* Any form of primary immunodeficiency (for example, severe combined immunodeficiency disease).\n* History of hepatitis B or hepatitis C currently receiving ongoing antiviral therapy.\n\nAny known uncontrolled cardiovascular disease at the time of Screening that, in the investigator's opinion, renders the participant ineligible\n\n* History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Presence of a CNS disorder that, in the opinion of the investigator, renders the participant ineligible for treatment.\n* History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.\n* Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding participants needing steroids for physiologic replacement).\n* Participant has received stem cell transplant within 90 days before Screening.\n* Participant has active graft-versus-host disease (GvHD) symptoms.\n* Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD, other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD, and no pulse steroid for disease control within 3 days of LD.\n* Radiotherapy within 4 weeks before Screening.\n* Presence of pleural\u002Fperitoneal\u002Fpericardial catheter, as well as permeant biliary and ureteral stents (does not apply to intravenous lines).\n* Participant has received live vaccine within 4 weeks before Screening. Note: Non-live virus vaccines are not excluded.\n* Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD.\n\nAdditional criteria apply.",{"count":568,"type":21},135,[24],"This is a Phase 1\u002F1b, nonrandomized, open-label, parallel assignment, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an allogeneic anti-CD19 CAR T, in adults with r\u002Fr B ALL, r\u002Fr B-cell NHL and CLL\u002FSLL.",[572,27,344,345],"Non-Hodgkin Lymphoma","2026-01-28",{"date":575,"type":32},"2026-02-02",{"date":577,"type":32},"2019-03-11",{"date":579,"type":21},"2027-06",{"name":581,"class":75},"Imugene Limited",23,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":17,"minAge":181,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":22,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":40},"100522251","phase-1-allogeneic-second-generation-cd19-car-t-cells-for-pediatric-relapsedrefractory-b-all-100522251","NCT06080191","Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed\u002FRefractory B-ALL","Phase I Clinical Trial on the Use of Fresh, Allogeneic, Second-generation CD19-CAR T Cells for Treatment of Children With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Patient Inclusion Criteria:\n\n1. Patients with a diagnosis of CD19 expressing B ALL relapse, and one of the following:\n\n   1. Relapse after alloHSCT OR\n   2. Relapsed\u002Frefractory disease, with failure of frontline therapy and at least 2 rescue strategies, including CD19\u002FCD22-directed monoclonal antibody and availability of a fully matched related donor.\n2. CD19+ count ≥ 50 cells\u002Fmcl and\u002For Minimal Residual Disease (MRD) ≥ 10\\^-4.\n3. Voluntary informed consent. For subjects \\\u003C 18-years old their legal guardian must give informed consent. Pediatric subjects will be included in age-appropriate discussion and verbal assent will be obtained for those greater than or equal to 12 years of age, when appropriate.\n4. Clinical performance status: patients \\> 16 years of age: Karnofsky greater than or equal to 60%; patients ≤ 16 years of age: Lansky score than or equal to 60%.\n5. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 4 months after receiving the lymphodepletion regimen.\n6. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.\n\nPatients Exclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Severe, uncontrolled active intercurrent infections.\n3. HIV, or active HCV and\u002For HBV infection.\n4. Life-expectancy \\\u003C 6 weeks or rapidly progressive disease that in the evaluation of the investigator would compromise ability to complete study therapy.\n5. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6x ULN.\n6. Renal function: serum creatinine \\>3x ULN for age.\n7. Blood oxygen saturation \\\u003C 90%.\n8. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO.\n9. Congestive heart failure, cardiac arrhythmia, psychiatric 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 subject.\n10. Presence of active, grade 2-4 acute or chronic Graf versus Host Disease (GvHD) requiring steroid therapy or other immune-suppressive treatment.\n11. Relapse occurring before 60 days after alloHSCT.\n12. Concurrent or recent prior therapies, before infusion:\n\n    i. systemic steroids (at a dose of ≥ 2 mg\u002Fkg prednisone) in the 2 weeks before infusion of CD19-CAR\\_Lenti\\_ALLO cells . Recent or recurrent use of inhaled\u002Ftopical\u002Fnon-absorbable steroids is not exclusionary.\n\nii. systemic chemotherapy in the 2 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\niii. anti-thymocyte globulin (ATG) or Alemtuzumab (Campath®)in the 8 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\niv. immuno-suppressive agentis in the 2 weeks preceding infusion of CD19-CAR\\_Lenti\\_ALLO cells\n\nv. radiation therapy must have been completed at least 2 weeks before infusion of CD19-CAR\\_Lenti\\_ALLO cells .\n\nvi. other anti-neoplastic investigational agents currently administered or within 30 days prior to infusion of CD19-CAR\\_Lenti\\_ALLO cells (i.e, start of protocol therapy).\n\nvii. Exceptions:\n\n1. there is no time restrictions in regards to intrathecal chemotherapy, but there must be a complete recovery from any acute toxic effects from such treatment.\n2. subjects receiving steroid therapy at physiologic replacement doses only are allowed provided that there has been no increase for at least 2 weeks to starting apheresis.\n\nDonor Eligibility Criteria\n\nConventional criteria for the eligibility of allogeneic donors will be adopted for the evaluation of cell donors, before apheresis, as required by law.","35 Years",{"count":303,"type":21},[24],"This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed\u002Frefractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).",[27],[596,597,598,599],"B-cell acute lymphoblastic leukemia","Children","Adolescent","Young adults","2025-11-25",{"date":602,"type":32},"2025-12-02",{"date":604,"type":32},"2024-04-28",{"date":606,"type":21},"2041-06-01",{"name":608,"class":39},"Bambino Gesù Hospital and Research Institute",{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":616,"maxAge":274,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":40},"100559058","phase-1-cd19x22-chimeric-antigen-receptor-t-cell-therapy-car-t-in-pediatric-b-all-100559058","NCT06559189","CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL","Phase I Dose Escalation and Preliminary Efficacy Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Pediatric Patients With Relapsed and\u002For Refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n1. Subjects must have a history of B precursor ALL with any of the following conditions:\n\n   1. Relapsed two or more times.\n   2. Relapsed at any time after allogeneic bone marrow transplant (BMT).\n   3. Relapse or refractory after single antigen targeting CAR T cell therapy.\n\n   i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and\u002For parents declining BMT options and would prefer CAR T Therapy.\n2. CD19 and\u002For CD22 present on last relapsed\u002Frefractory disease evaluation.\n3. Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).\n4. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.\n5. Males OR non-pregnant, non-lactating females.\n6. Aged 3 months to 30 years (inclusive) at time of consent and enrollment.\n7. Provision of a signed and dated consent form from parent or guardian (patients \\\u003C 18), the patient themselves (\\> 18), or legally authorized representative (patient \\> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.\n8. Stated willingness to comply with all study procedures and be available for the duration of the study.\n9. Willingness to participate in long-term follow-up protocol.\n\nExclusion Criteria:\n\n1. Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.\n2. History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:\n\n   1. Less than 100 days post-transplant;\n   2. Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;\n   3. Less than 6 weeks post donor lymphocyte infusion (DLI).\n3. Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.\n4. Evidence of severe organ dysfunction defined by:\n\n   1. Baseline oxygen saturation of \\\u003C 90% on room air\n   2. Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings\n   3. Transaminases \\> 10x upper limit of normal (ULN) or bilirubin \\> 5x the ULN, unless thought to be related to primary disease\n   4. Estimated Creatinine (Cr) clearance \\\u003C 60 mL\u002Fmin\u002F1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)\n5. Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product\n6. Known HIV infection or active Hepatitis B or Hepatitis C infection.","3 Months",{"count":618,"type":21},53,[24],"This study will evaluate the safety and tolerability of administering a novel bispecific CD19\u002FCD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.",[27],[623,528,624,27,625],"Pediatric","Refractory","Hematologic diseases","2025-11-21",{"date":628,"type":32},"2025-11-28",{"date":630,"type":32},"2024-09-27",{"date":632,"type":21},"2029-12",{"name":294,"class":39},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":641,"maxAge":113,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":40},"100555086","phase-1-blinatumomab-and-auto-hsct-sandwich-strategy-as-consolidation-therapy-for-b-all-100555086","NCT06507514","Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL","Safety and Efficacy of Blinatumomab and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT.\n* positive expression of CD19 in peripheral blood or bone marrow primary cells detected by flow cytometry.\n* ardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg\u002Fdl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg\u002Fdl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \\> 91% without oxygenation.\n* subjects aged 15-65 years (including 15 and 65 years), regardless of gender.\n* T-cell amplification test pass.\n* expected survival \\> 3 months.\n\nExclusion Criteria:\n\n* patients with recurrence of only isolated extramedullary lesions. combination of other malignant tumors.\n* previously treated with anti-CD19 therapies.\n* immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent.\n* uncontrolled active infections.\n* HIV infection.\n* active hepatitis B or hepatitis C infection.\n* history of severe tachyphylaxis to aminoglycoside antibiotics.\n* history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.","15 Years",{"count":643,"type":21},4,[24],"Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the main method potentially curing adult B-ALL, but the high treatment-related mortality (NRM) affects overall survival (OS). Autologous stem cell transplantation (auto-HSCT) can significantly reduce NRM but has a higher relapse rate. Studies have confirmed that achieving MRD negativity before Auto-HSCT can effectively reduce post-transplant relapse, achieving similar efficacy to allo-HSCT. The efficacy of blinatumomab in clearing MRD has been confirmed. Therefore, using blinatumomab combined with Auto-HSCT for B-ALL patients seems to make it possible to achieve benefits in leukemia free survival（LFS） and OS. The investigators first conducted blinatumomab and auto-HSCT \"sandwich \" strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.",[27],"2025-11-18",{"date":626,"type":32},{"date":650,"type":32},"2024-04-01",{"date":652,"type":21},"2030-04-01",{"name":654,"class":39},"The First Affiliated Hospital of Soochow University"]