[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-lymphoma-refractory\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-lymphoma-refractory":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,76,105,135,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100558549","phase-1-selinexor-with-ice-chemotherapy-in-secondary-central-nervous-system-involving-b-cell-non-hodgkin-lymphoma-100558549",false,"NCT06552559","Selinexor With ICE Chemotherapy in Secondary Central Nervous System Involving B-cell Non-Hodgkin Lymphoma","Phase 1\u002F2 Study of Selinexor With Dexamethasone, Ifosfamide, Carboplatin, and Etoposide in Patients Who Have Secondary Central Nervous System Involvement With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma","SIENA","Inclusion Criteria:\n\n* Patients must have histologically confirmed B-cell NHL with CNS involvement DLBCL including ABC, GCB or PMBCL subtypes Indolent lymphomas transformed to aggressive lymphomas Follicular lymphomas\n* Patients must have received at least one cycles of anthracycline based chemotherapy administered with curative intent\n* Patients must be age ≥18 years.\n* Patients must have at least one site of measurable disease, 1.5 cm in diameter or greater.\n* Patients must have ECOG performance status of 0-2.\n* Patients must have laboratory test results within these ranges: Absolute neutrophil count ≥ 1500\u002Fmm³, Platelet count ≥ 100,000\u002Fmm³, Serum creatinine clearance ≥40 mL\u002Fmin, Total bilirubin ≤ 1.5x ULN (Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.), AST (SGOT) and ALT (SGPT) ≤ 2x ULN\n* Women of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test prior to selinexor treatment. Male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential.\n* Patients must be able to understand and willing to sign a written informed consent document.\n* Patients must be able to adhere to the study visit schedule and other protocol requirements.\n* Patients must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.\n* Patients must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n* Patients with hepatitis B virus including HBsAg-positive carrier or IgG anti- HBc-positive can be enrolled if they can receive anti-viral prophylaxis\n\nExclusion Criteria:\n\n* Patients cannot fulfill the above-mentioned inclusion criteria\n* Patients with primary CNS lymphoma\n* Patients with a prior history with selinexor","ALL","18 Years",{"count":20,"type":21},37,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Secondary involvement of the central nervous system (CNS), such as CNS relapse after treatment or progression during treatment, is a rare but deadly occurrence in patients with B-cell non-Hodgkin lymphoma (NHL), particularly in cases of diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma (FL). Despite the grim prognosis associated with secondary CNS involvement, no definitive treatment strategy exists. Selinexor®, an oral, first-in-class, potent selective inhibitor of nuclear export that binds to XPO1, leads to the nuclear retention of tumor suppressor and growth regulator proteins, as well as topoisomerase II enzymes, thereby restoring their functions. Preclinical studies have also shown that selinexor can sensitize cancer cells to topoisomerase inhibitors, alkylating agents, and steroids. Selinexor has been approved by the Food and Drug Administration for relapsed or refractory DLBCL. We hypothesize that selinexor could work synergistically with ifosfamide (an alkylating agent) and etoposide (a topoisomerase II inhibitor) in the ifosfamide, carboplatin, and etoposide (ICE) regimen. High-dose dexamethasone was added to this regimen to enhance the efficacy of ICE as a salvage regimen for secondary CNS involvement, due to its ability to cross the blood-brain barrier.\n\nThis phase I\u002FII study aims to evaluate the efficacy and safety of selinexor in combination with ifosfamide, carboplatin, etoposide (ICE), and dexamethasone in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with secondary CNS involvement.",[28,29,30],"B-cell Lymphoma Recurrent","B-cell Lymphoma Refractory","CNS Metastases",[32,33,34,35],"Non-Hodgkin B-cell lymphoma","Secondary CNS involvement","Selinexor","ICE","RECRUITING","2026-04-22",{"date":39,"type":40},"2026-04-23","ACTUAL",{"date":42,"type":40},"2024-05-01",{"date":44,"type":21},"2028-12-30",{"name":46,"class":47},"Samsung Medical Center","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100617519","phase-1-antigen-targeted-t-cell-therapy-for-relapsedrefractory-b-cell-lymphomas-100617519","NCT07319676","Antigen Targeted T Cell Therapy for Relapsed\u002FRefractory B Cell Lymphomas","Inclusion Criteria\n\n* Age 10 to 80 years at screening\n* PET-CT measurable disease by Lugano classification (Deauville score of ≥4) and\n* Tissue biopsy of any tumour site and flow cytometry study of CD19 and CD22 expression.\n* Relapsed B-cell lymphoma after one line of systemic therapy or autologous bone marrow transplant. This includes DLBCL, PMBCL, HGBCL, DLBCL arising from indolent lymphoma, Burkitt's lymphoma\u002Fleukemia, Mantle cell lymphoma.\n* High risk B-cell lymphoma (BCL). High risk BCL is defined by any of the criteria below:\n\n  * High-risk genetics - double\u002Ftriple hit or p53mut or deletion.\n  * IPI score ≥ 3\n  * Richter's transformation from chronic lymphocytic leukaemia.\n  * Disease refractory to treatment - PET-CT positive disease after 2 courses of rituximab-containing chemoimmunotherapy.\n* PBMC product available\n* Karnofsky or Lansky score \\>70. Or ECOG 0-2\n* Patient expected survival is more than 3 months to allow for manufacture and release of CAR T-cells.\n\nExclusion Criteria\n\n* Patients who test positive on urine or blood pregnancy testing and are pregnant or are lactating.\n* Participant of reproducible age who refuse the use of the following birth control methods if engaging in sexual activity that could lead to pregnancy. The methods include condoms, diaphragm, intrauterine device, hormonal based contraception.\n* Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome.\n* Active hepatitis B or hepatitis C within 3 months of screening.\n* Active HIV infection within 3 months of screening.\n* Grade 2 to 4 graft-vs-host disease (GVHD).\n* Received an investigational medicinal product within 1 month of screening.\n* If the total sum of CD19 and CD22 antigens expressed is less than 95.0%, patients will not be eligible. If subsequent immunophenotying of the patient's sample confirms that total sum of CD19 and CD22 antigens ≥ 95%, the patient may be rescreened.\n* Central nervous system: Uncontrolled seizures or status epilepticus; decreased conscious state (any cause)\n* Foreign patients who cannot commit to agreeable to stay in Singapore for at least 3 months post CAR T infusion and are committed to the long term monitoring post CAR T at home and in Singapore.\n* Prior treatment with any CAR T cell therapy (approved or investigational)","10 Years","80 Years",{"count":58,"type":21},30,[24,25],"This is a single center, open label, phase 1 lead in to determine Recommended Phase 2 Dose (RP2D), followed by a phase 2 trial to evaluate the safety and efficacy of Epo-R-CD19 CAR T with or without CD22 CAR T-cells infused into patients with B cell lymphoma.\n\nThe study will have the following parts:\n\n* Screening\n* Pre-infusion (cell product preparation and bridging) and infusion (lymphodepletion)\n* Primary efficacy endpoints\n* Long term follow up\n\nPatients who have high risk B cell lymphoma or relapsed\u002Frefractory B cell lymphoma who fufil the trial inclusion and exclusion criteria will undergo leukapheresis following trial enrollment.\n\nCAR T-cell products will then be manufactured according to the antigen expression on the patient's biopsied tumor cells. These cells will then undergo stringent testing before the patient undergoes lymphodepletion followed by CART infusion. These patients will be admitted for the infusion and closely monitored for any CRS or ICANS.\n\nThis study will have a Phase 1 safety run in for the first 3-6 patients who receive the Epo-R-CD19 CAR T (with or without epoetin (erythropoietin)) to determine the tolerability and safety of this product. For the first 3-6 patients, if there are any DLT seen by Day 28, a data safety monitoring committee will be convened to assess the trial. Staggered dosing will be implemented for the first 2 participants in every dose level (DL1, DL2 and DL-1).\n\nFor Phase 2, the RP2D will depend on DLT. If there is no DLT at DL+1 and DL+2, then the investigators will proceed with DL+2 as the RP2D dose. On the other hand, if there is DLT despite DL-1, then the study will be redesigned. Phase 2 will continue until a total of 20 patients received their CAR T-cell infusions.\n\nCAR-T monitoring will be performed at Day 0, 7, 14, 21, 28, month 2, 3, 4, 5, 6, 12 and yearly thereafter. The total duration of the study is 15 years from CAR T infusion.",[29],[63,64,65],"Antigen targeted","T cell therapy","Relapsed\u002FRefractory B cell lymphomas","2026-04-05",{"date":68,"type":40},"2026-04-09",{"date":70,"type":40},"2026-03-02",{"date":72,"type":21},"2040-10-31",{"name":74,"class":47},"National University Hospital, Singapore",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":75},"100617644","phase-2-polymer-lipid-particle-delivered-car1920-mrna-car-t-therapy-for-relapsedrefractory-b-cell-lymphomaleukemia-100617644","NCT07321301","Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed\u002FRefractory B-cell Lymphoma\u002FLeukemia","An Exploratory Clinical Study of CAR-T Cell Immunotherapy Using Polymer-lipid Particles to Deliver CAR1920 mRNA Targeting CD19\u002FCD20 for Thetreatment of Relapsed\u002FRefractory B-cell Lymphoma\u002FLeukemia","Inclusion Criteria:\n\n1. Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol;\n2. Patients with relapsed\u002Frefractory (R\u002FR) B-cell lymphoma\u002Fleukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options;\n3. Must meet the following criteria for R\u002FR B-cell malignant tumors:\n\n(1) B-cell tumors include 3 categories:\n\n* B-cell acute lymphoblastic leukemia (B-ALL);\n\n  ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.;\n\n  ③ Aggressive B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), mantle cell lymphoma (MCL); (2) R\u002FR B-ALL (meeting any 1 of the 4 criteria below):\n* Relapse within 6 months after the first complete response (CR);\n\n  * Primary refractory patients who failed to achieve CR after 2 cycles of standard chemotherapy;\n\n    * Failure to achieve CR or relapse after first-line or multi-line salvage chemotherapy; ④ Relapse after hematopoietic stem cell transplantation (HSCT); (3) R\u002FR B-cell lymphoma (meeting any 1 of the first 4 criteria below plus criterion 5):\n* Tumor reduction \\\u003C 50% or disease progression after 4 courses of standardized chemotherapy per standard regimens;\n\n  * Relapse within 6 months after achieving CR with standard chemotherapy;\n\n    * ≥ 2 relapses after CR;\n\n      * Relapse after HSCT; ⑤ Adequate prior treatment received, including at least anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy regimens; 4. Aged 18-85 years (inclusive), male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival \\> 14 days from the date of signing the informed consent form; 7. Hemoglobin (HGB) ≥ 60 g\u002FL (transfusion allowed); 8. Absolute neutrophil count (ANC) ≥ 1,000\u002Fμl and platelet count ≥ 45,000\u002Fμl in peripheral blood (transfusion allowed); 9. Hepatic, renal, cardiac, and pulmonary functions meeting the following requirements:\n\n        1. Total Bilirubin (TBIL) ≤ 1.5 × Upper Limits of Normal (ULN), excluding subjects with Gilbert's syndrome;\n        2. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN;\n        3. Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance Rate (CCr) ≥ 60 mL\u002Fmin (CCr estimated by the Cockcroft-Gault formula);\n        4. Left Ventricular Ejection Fraction (LVEF) ≥ 50%; echocardiogram (ECHO) confirms no clinically significant severe pericardial effusion or severe arrhythmia;\n        5. Baseline transcutaneous oxygen saturation \\> 90% under room air;\n        6. No clinically significant severe pleural effusion; 10. Subjects with pregnancy plans must agree to use contraceptive measures from before study enrollment until 6 months after the end of the study;\n\nExclusion Criteria:\n\n1. Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;\n2. History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;\n3. Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as meeting all three of the following criteria: a. HBV DNA quantitation ≥ 2000 IU\u002Fml; b. ALT ≥ 2 × Upper Limits of Normal (ULN); c. Exclusion of hepatitis caused by other factors such as the disease itself or medications. If a patient was diagnosed with active HBV infection initially and converted to inactive HBV infection after anti-HBV treatment, they may be included in this study with adequate ongoing anti-HBV treatment);\n4. Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT \\> 3 × ULN, AST \\> 3 × ULN, TBIL \\> 2 × ULN, or serum creatinine clearance \\\u003C 30 mL\u002Fmin;\n5. History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiovascular diseases within 12 months prior to enrollment;\n6. Other severe medical conditions that may affect the study (e.g., poorly controlled diabetes mellitus, gastric ulcer, other severe cardiorespiratory diseases, concurrent severe autoimmune diseases or congenital immunodeficiencies, uncontrolled severe infections, etc.), as well as other diseases with a high risk of condition deterioration; patients who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and still have acute graft-versus-host disease (GVHD) 1 month after discontinuing immunosuppressants. The decision is at the investigator's discretion;\n7. History of severe immediate-type hypersensitivity reactions to any specific drugs required in this study; or history of severe hypersensitivity to biological products (including antibiotics);\n8. Female subjects who are pregnant or lactating (due to potential risks of treatment to the fetus or infant);\n9. Subjects judged by the investigator to be unable to complete all scheduled visits, investigations, or diagnostic and therapeutic procedures required by the study protocol (including medium- and long-term follow-up visits), those with poor willingness to participate, those who are unwilling to join or fully cooperate with the study arrangements, or those with insufficient compliance of the subject and their family members. The decision is at the investigator's discretion;\n10. Concurrent progressive malignant tumors of other types; or a history of other malignant tumors, except for non-melanoma skin cancers and carcinoma in situ (e.g., of the cervix, bladder, or breast). Subjects with a history of other malignant tumors are ineligible unless they have been disease-free and not received any form of anti-tumor treatment for at least 3 consecutive years;\n11. History of live vaccine vaccination within 6 weeks prior to the start of the conditioning regimen;\n12. Receipt of major surgical procedures (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period;\n13. Other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for participation by the investigator.","14 Years","85 Years",{"count":86,"type":21},10,[25],"The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19\u002FCD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed\u002Frefractory B-cell lymphoma\u002Fleukemia.",[29],[91,29,92,93,94,95],"consolidation therapy","CAR-T","Lipid Nanoparticles","RNA Transport","Patient Safety","2025-12-22",{"date":98,"type":40},"2026-01-07",{"date":100,"type":40},"2025-09-01",{"date":102,"type":21},"2027-08-31",{"name":104,"class":47},"Daihong Liu",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":75},"100493470","phase-1-clinical-trial-using-car--t-cells-for-treatment-of-patients-with-refractory-or-relapsed-cd19-positive-b-lymphoid-malignancies-100493470","NCT05705570","Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies","A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies","CARTHIAE-1","Inclusion Criteria:\n\n1. Subjects must have relapsed or refractory ALL, lymphoma or CLL treated with at least two lines of therapy. Disease must have either progressed after the last regimen or presented failure to achieve partial or complete remission with the last regimen.\n\n   Subjects with Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs).\n\n   Subjects with DLBCL must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti-CD20 monoclonal antibody.\n\n   Subjects with transformed FL, MZL, or CLL\u002FSLL must have progressed, had SD or recurred with transformed disease after initial treatment for DLBCL.\n\n   Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.\n2. 2\\. The patient's disease must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.\n3. Age 2 to 70 years.\n4. Performance status: Adult Subjects: ECOG ≤ 2 for patients ≥ 16 years; Subjects \\\u003C 16 years of age: lansky ≥ 50%\n5. Normal Organ and Marrow Functioning (supportive treatment is allowed according to institutional standards, i.e. filgrastim, transfusion)\n\n   • Total Bilirubin ≤ 2; AST (SGOT) ≤ 5 times the upper limit of normal; ALT (SGTP) ≤ 5 times the upper limit of normal; Serum creatinine ≤ 1.5; Pulse oximetry \\>91% on room air; No dyspnea or mild dyspnea (≤ Grade 1); Forced expiratory volume in 1 s (FEV1) ≥50% or carbon monoxide diffusion test (DLCO) ≥50% of predicted level; Left ventricular ejection fraction ≥ 45% confirmed by echocardiogram; Subjects must have the following hematologic function parameters: Neutrophils \\> 1000\u002FuL; Absolute Lymphocyte Count \\> 100\u002FuL; Platelets ≥ 50,000\u002FL Patient should not be excluded if change of the above parameters due to spinal cord disease infiltration;\n6. Prior therapy wash-out - At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives, Blinatumomab with 4 months prior CAR-T infusion.\n7. For women of reproductive potential: use a highly effective contraceptive for at least 1 month prior to screening and agree to use a method during study participation and for an additional 4 months after CAR T-cell administration has ended.\n8. Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Autologous transplant within 6 weeks of planned CAR-T cell infusion;\n2. History of allogeneic stem cell transplant 4 months prior CAR T cell infusion.\n3. Use of immunosuppression therapy;\n\n   • Patients must have completed immunosuppression therapy; Systemic corticosteroid therapy must be stopped more than 72 hours after infusion; Systemic drugs for graft-versus-host disease should be withheld at least 4 weeks prior to infusion;\n4. Presence of graft-versus-host disease Grade ≥ 2;\n5. Receiving CAR T cell treatment outside of this protocol;\n6. Active central nervous system or meningeal involvement by tumor. Subjects with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration.\n7. History of active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).\n8. HIV infection; HTLV\n9. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n10. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects.\n11. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy\n12. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n13. Serious and\u002For potentially fatal medical conditions\n14. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n15. History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n16. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication\u002Fsalvage therapies for treatment related toxicities;","2 Years","70 Years",{"count":58,"type":21},[24],"This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL\u002FCLL (Cohort 3).",[119,120,28,29,121,122],"Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia Refractory","Chronic Lymphocytic Leukemia Recurrent","Chronic Lymphocytic Leukemia Refractory",[124,125],"CAR T cell","CD19+ B-cell Malignancies","2025-09-22",{"date":128,"type":40},"2025-09-25",{"date":130,"type":40},"2023-02-07",{"date":132,"type":21},"2028-12-01",{"name":134,"class":47},"Nelson Hamerschlak",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":148,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":48},"100550340","phase-1-cd19cd22-car-t-cells-in-adults-with-rr-all-or-nhl-100550340","NCT06445803","CD19\u002FCD22 CAR-T Cells in Adults With R\u002FR ALL or NHL","A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19\u002FCD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Male or female,≥18 years old;\n* Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following conditions):\n\n(B-NHL)\n\n1. Second or greater relapse (CD20 regimens must be included) OR\n2. Refractory to first-line chemotherapy or relapse within 1 year OR\n3. Relapse within 1 year of auto-HSCT.\n4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)\n\na. Relapse within 12 months of complete remission on first treatment OR b. Relapse after second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR\u002FCRi at the end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after treatment with at least two and more TKIs.\n\n* ECOG 0\\~2\n* Estimated survival time ≥ 12 weeks;\n* Main tissues and organs function well.\n\nExclusion Criteria:\n\n* Subjects will be excluded related to the following prior therapy criteria:Prior treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks; Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week; glucocorticoids (prednisone ≥7.5 mg\u002Fd or equivalent) within 72 h\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to angina pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York Heart Association (NYHA) classification of ≥ Class III congestive heart failure, severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic disorders, and hypertension that is uncontrolled by standard therapy；\n* active bleeding, or venous thromboembolic event\n* Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that result in end-organ damage or require systemic application of immunosuppressive drugs\n* Central nervous system (CNS) disease or symptoms of CNS involvement\n* Pregnant or nursing (lactating) women\n* Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2 neuropathy excluded\n* Any Iinappropriate conditions in the opinion of the PI .",{"count":143,"type":21},48,[24],"This study examines the safety, tolerability and preliminary efficacy of anti-CD19 \u002FCD22 CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.",[119,147,29,28],"Acute Lymphoblastic Leukemia With Failed Remission",[149],"CAR-T therapy","2024-06-01",{"date":152,"type":40},"2024-06-06",{"date":154,"type":40},"2024-05-31",{"date":156,"type":21},"2026-12",{"name":158,"class":47},"Rong Tao",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":75},"100509105","phase-1-safety-and-efficacy-of-autologous-nk-cell-adjuvant-therapy-for-relapsedrefractory-non-hodgkins-b-cell-lymphoma-100509105","NCT05909098","Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed\u002FRefractory Non-Hodgkin's B-cell Lymphoma","Xiangyang No.1 People's Hospital, Hubei University of Medicine","Inclusion Criteria:\n\n1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months.\n2. Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.\n3. First diagnosed relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma.\n4. ECOG scores were 0 to 2\n5. Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.\n6. For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.\n7. For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.\n8. Volunteer to participate in the trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of bone marrow or\u002Fand central nervous system lymphoma.\n2. Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.\n3. Combined with other malignancies.\n4. Fever of non-disease-related origin within the last 5 days.\n5. Presence of uncontrollable bacterial, fungal, viral or other infections.\n6. Patients with HIV, TP positive\n7. Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.\n8. Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.\n9. Received any form of organ transplantation, including allogeneic stem cell transplantation.\n10. Presence of a serious psychiatric disorder.\n11. Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.\n12. Pregnant or lactating women.\n13. The researchers deemed unsuitable for participation in this study. -",{"count":167,"type":21},33,[24,25],"This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed\u002Frefractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.",[171,28,29],"NK Cell","NOT_YET_RECRUITING","2023-06-19",{"date":175,"type":40},"2023-06-22",{"date":177,"type":21},"2023-07-01",{"date":179,"type":21},"2028-11-30",{"name":181,"class":47},"Xiangyang No.1 People's Hospital"]