[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkin-lymphoma-b-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkin-lymphoma-b-cell":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,74,103,139,166],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100516758","a-prospective-observational-cohort-study-on-the-clinical-impact-of-novel-monoclonal-antibodies-in-b-cell-non-hodgkin-lymphoma-in-italian-clinical-practice-100516758",false,"NCT06008691","A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice","A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice","FIL_MAB","Inclusion Criteria:\n\n* Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory.\n* Patients aimed to be treated in indication with a \"novel\" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Being involved in a prospective interventional trial outside indication.\n* Patients treated outside approved indications:\n\n  * 648-approved indication.\n  * 5% AIFA support.\n  * Compassionate use.\n* Age less than 18 years.\n* Inability to provide an informed consent.","ALL","18 Years",{"count":20,"type":21},1500,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.",[25],"Non-Hodgkin Lymphoma, B-cell",[27,28,29,30],"Non-Hodgkin Lymphoma","B-cell","monoclonal antibodies","novel antibodies","RECRUITING","2025-12-22",{"date":34,"type":35},"2025-12-29","ACTUAL",{"date":37,"type":35},"2023-12-27",{"date":39,"type":21},"2038-10",{"name":41,"class":42},"Fondazione Italiana Linfomi - ETS","OTHER",61,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100557155","phase-2-men1703-sel24-to-treat-relapsed-or-refractory-aggressive-b-cell-non-hodgkin-lymphoma-jaspis-01-100557155","NCT06534437","MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)","An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma","JASPIS-01","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed indolent B-cell lymphoma\n3. Relapsed or refractory disease having received at least 2 prior lines of systemic treatment and, naïve to anti-CD3xCD20 bispecific antibody treatment (group 1) or exhausted all standard, available treatment options (group 2)\n4. At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.\n5. Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)\n6. Life expectancy of ≥12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2\n8. Adequate organ function at Screening\n9. Adequate hematologic function\n\nExclusion Criteria:\n\n1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.\n2. Received anti-cancer treatments, including cytotoxic chemotherapy, radiotherapy, hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Prior treatment with CAR-T cell or an anti-CD3xCD20 bispecific antibody therapy (permitted for Group 2 only), requires a wash out period of ≥4 weeks.\n3. Concurrent participation in another therapeutic clinical study.\n4. Ongoing clinically significant toxicity (for example, alopecia is not clinically significant) from any prior anti-cancer therapy that has not resolved to Grade 1 or less prior to the first dose of study drug.\n5. Prior treatment with a PIM inhibitor.\n6. Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.\n7. Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients\n8. Contraindication to all uric acid lowering agents.\n9. Major surgery within 1 month prior to first dose of study drug.\n10. Hematopoietic stem cell transplant within 4 months prior to first dose of study drug.\n11. Requires systemic immune-modulating therapy (regardless of dose) or has confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression.\n12. Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing the informed consent form (ICF).\n13. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection, except for documented Grade Common Terminology Criteria for Adverse Events (CTCAE) ≤2 infections with evidence of improvement or without evidence of worsening infection.\n14. Known human immunodeficiency virus (HIV) infection\n15. Current active liver disease from any cause\n16. Ongoing drug-induced pneumonitis.\n17. Ongoing inflammatory bowel disease.\n18. Active known second malignancy\n19. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substrate with a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRP inhibitor within 14 days or 5 half-lives (whichever is shorter), prior to the first dose of study drug.\n20. Cardiac dysfunction is defined as myocardial infarction within 6 months of study entry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, or poorly controlled angina.\n21. Receiving treatment for active, ongoing thromboembolic event. Note: Does not apply to prophylactic treatment to prevent or avoid reoccurrence of a prior resolved event. To review with Medical Monitor where further risk assessment is needed.\n22. History of serious ventricular arrhythmia (e.g., VT or VF, ≥3 beats in a row), or QT interval corrected for heart rate (QTc) ≥480 ms.\n\n    Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g., bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled.\n23. Any disease, syndrome or condition which may significantly affect drug intake via oral route.\n24. Planning to become pregnant or breastfeed during treatment and for 1 month after the last dose of study drug.\n25. Any other prior or current medical condition, intercurrent illness, surgical history, physical or 12-lead electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that, in the investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.",{"count":53,"type":21},178,"INTERVENTIONAL",[56],"PHASE2","The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed\u002Frefractory (R\u002FR) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time:\n\n* Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma\n* Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.",[25],[60,61,62],"Relapsed","Refractory","Aggressive","2025-09-23",{"date":65,"type":35},"2025-09-29",{"date":67,"type":35},"2024-12-05",{"date":69,"type":21},"2026-12",{"name":71,"class":72},"Ryvu Therapeutics SA","INDUSTRY",36,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":54,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100550365","early-phase-1-a-dose-escalating-study-of-cd19cd22bcma-car-t-therapy-in-relapsed-or-refractory-b-cell-non-hodgkin-lymphomanhl-100550365","NCT06446128","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)","A Dose Escalating Study of CD19\u002FCD22\u002FBCMA Three Targets Autologous Chimeric Antigen Receptor T (CAR-T) Cell Therapy in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)","Key Inclusion Criteria:\n\n* Patients who are diagnosed with relapsed\u002Frefractory B cell non-Hodgkin lymphoma , especially\n\n  * Diffuse Large B Cell Lymphoma, not other specified (DLBCL,NOS),\n  * Primary Mediastinal Large B Cell Lymphoma (PMBCL)\n  * Transformation Follicular Lymphoma (TFL)\n  * High grade B-cell lymphoma(HGBCL)\n  * High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) \u002FBCL6 (B-cell lymphoma6) rearrangement\n* Refractory diseases are defined as one of the following\n\n  * No response to last line of therapy: i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to most recent therapy regimen\n  * Not candidate for autologous stem cell transplant (ASCT) or refractory post-ASCT: i. Disease progression (PD) or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy\n* Individuals must have received 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* Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)\n* At least one measurable lesion during the screening based on the recommendation for initial evaluation, staging and response assessment of Hodgkin and non-Hodgkin lymphoma.\n* Life expectancy ≥ 12 weeks\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n  * Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL\u002Fmin\u002F1.73m2 \\[eGFR(estimated glomerular filtration rate)=186×age\\^-0.203×SCr\\^-1.154（mg\u002Fdl）,female×0.742\\]\n  * Hepatic function: i: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air\n  * Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)\n* Adequate bone marrow function, define as:\n\n  * absolute neutrophil count (ANC) ≥1 ×10\\^9\u002FL\n  * absolute lymphocyte count (ALC)≥ 0.5 ×10\\^9\u002FL\n  * Platelets ≥50 ×109\u002FL；\n  * Hemoglobulin ≥80 g\u002FL; patients with bone marrow involvement can be enrolled if globulin\\>60 g\u002FL\n* Female of child-bearing age and male participants must agree to use effective contraceptive methods until no CAR-T cells can be detected by PCR(polymerase chain reaction) test.\n\nKey Exclusion Criteria:\n\n* Individuals who have antiCD45 or antiCD3 therapy\n* Individuals with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of primary or secondary CNS (central nervous system) lymphoma, cerebrospinal fluid malignant cells or brain metastases\n* Presence or history of CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* History of allogeneic stem cell transplantation\n* Any of the following situations:\n\n  • HBsAg\u002F HBeAg positive; HBeAb\u002FHBcAb positive and HBV(hepatitis B virus) DNA copies above the lower test limit;\n* HCV(hepatitis C virus) RNA positive\n* HIV(human immunodeficiency virus) positive or treponema pallidum positive\n* Presence of active or life-threatening fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management.\n* Individuals presence of unstable angina or myocardial infarction within 6 months of screening, or other severe\u002Funcontrolled diseases during the screening (eg. Unstable or uncompensated respiratory, cardiac, hepatic or renal disease)\n* Presence of uncontrolled arrhythmia with treatment\n* Pregnancy or breastfeeding women\n\nOther protocol defined inclusion\u002Fexclusion criteria may apply.",{"count":82,"type":21},20,[84],"EARLY_PHASE1","This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19\u002FCD22\u002FBCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.",[25],[88,89,90,91,92],"B cell non-hodgkin lymphoma","CAR-T","CD19","CD22","BCMA","2025-08-19",{"date":95,"type":35},"2025-08-21",{"date":97,"type":35},"2024-05-07",{"date":99,"type":21},"2026-12-31",{"name":101,"class":72},"Shanghai Cell Therapy Group Co.,Ltd",1,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":54,"phases":115,"briefSummary":117,"conditions":118,"keywords":125,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":102},"100532502","phase-1-fourth-gen-car-t-cells-targeting-cd19cd22-for-highly-resistant-b-cell-lymphomaleukemia-pmbclcns-bcl-100532502","NCT06213636","Fourth-gen CAR T Cells Targeting CD19\u002FCD22 for Highly Resistant B-cell Lymphoma\u002FLeukemia (PMBCL\u002FCNS-BCL).","T-cell Infusion Targeting CD19 and CD22 for Refractory\u002FRelapsed Leukemia\u002FLymphoma Patients With or Without Central Nervous System Involvement","BAH241","Inclusion Criteria:\n\n* Diagnosis: ALL In view of the PI and the primary oncologist, there must be no available alternative curative therapies or subject has declined to pursue alternative therapy; and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment.\n* Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of therapies\n* Recurrence of disease after achieving a complete response (CR).\n* Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart.\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* Subjects with recurrence of isolated CNS relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart.\n* Diagnosis: Lymphoma Subjects with lymphoma must have progressed, had SD, or recurred after initial treatment regimens that include an anthracycline and an anti CD20 monoclonal antibody. Subjects who relapse ≥12 months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant.\n* CD19 expression CD19 expression is required at any time since diagnosis. If patient has received anti-CD19 targeted therapy (i.e. Blinatumomab), then CD19 expression must be subsequently demonstrated. CD19 expression. must be detected on greater than 50% of the malignant cells by immunohistochemistry or ≥ 90% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples.\n* Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post-transplant, they have no evidence of active GVHD and have been without immunosuppressive agents for at least 30 days.\n* Subjects who have undergone prior anti-CD19 or anti-CD22 CAR therapy will be eligible if \\\u003C 5% of circulating levels of CD3+ cells express the previous CAR by flow cytometry.\n* Must have evaluable or measurable disease; subjects with lymphoma must have evaluable or measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma\\[66\\] must be present. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n* 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.\n* Exceptions:\n* There is no time restriction with regard to prior intrathecal chemotherapy (incl. steroids) provided there is complete recovery from any acute toxic effects of such; g. Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; h. Subjects who are on standard ALL maintenance type chemotherapy (vincristine, 6-mercaptopurine or oral methotrexate) may be enrolled provided that chemotherapy is discontinued at least 1 week prior to apheresis.\n* Subjects receiving steroid therapy at physiologic replacement doses (≤ 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis; j. For radiation therapy: Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than 10% and also the subject has measurable\u002Fevaluable disease outside the radiation port.\n* Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities, such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities)\n* Age Greater than or equal to 1 year of age and less than or equal to 30 years of age at time of enrollment; must meet parameters for apheresis per institutional guidelines. NOTE: The first subject in the first dose cohort must be ≥ 18 years of age if an adult has not been treated at that dose cohort on the companion Stanford protocol \"Phase 1 Dose Escalation Study of CD19\u002FCD22 Chimeric Antigen Receptor (CAR) T Cells in Adults with Recurrent or Refractory B Cell Malignancies\" and undergone safety evaluation at Day 28 without evidence of DLT.\n* Performance Status: Subjects \\> 10 years of age: Karnofsky ≥ 50%; Subjects ≤ 10 years of age: Lansky scale ≥ 50% (See Appendix B Section 14.2)\n* Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)\n* ANC ≥750\u002FuL\\*\n* Platelet count ≥50,000\u002FuL\\*\n* Absolute lymphocyte count ≥150\u002FuL\\*\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n* Serum ALT\u002FAST ≤10 ULN (unless elevated ALT\u002FAST is attributed to leukemia or lymphoma involvement of the liver, in which case this criterion will be waived and not disqualify a patient).\n* Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n* Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO, and no clinically significant ECG findings\n* No clinically significant pleural effusion\n* Baseline oxygen saturation \\>92% on room air at rest\n* creatinine: within age adjusted normal institutional limits (see table below) OR\n* creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m2 (as estimated by Cockcroft Gault Equation) for subjects with creatinine levels above institutional normal.\n* Age (Years) Maximum Serum Creatinine (mg\u002FdL)\n\n  -≤5 0.8 5 \\\u003C age ≤ 10 1.0 \\>10 1.2\n* if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies.\n* CNS Status\n* Subjects with ALL\n* Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\nCNS 2a: \\\u003C10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2b: ≥10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts; CNS 2c: ≥10\u002FµL RBCs; ≥5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n\n* Subjects with lymphoma\n* Subjects must have no signs or symptoms of CNS disease or detectable evidence of CNS disease on MRI at the time of screening. Subjects who have previously been treated for CNS disease and who have the following CNS status will be eligible:\n* CNS 1, defined as absence of blasts in cerebral spinal fluid (CSF) on cytospin preparation, regardless of the number of WBCs;\n* CNS 2, defined as presence of \\\u003C 5\u002FµL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FµL WBCs but negative by Steinherz\u002FBleyer algorithm:\n* CNS 2a: \\\u003C 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2b: ≥ 10\u002FµL RBCs; \\\u003C 5\u002FµL WBCs and cytospin positive for blasts;\n* CNS 2c: ≥ 10\u002FµL RBCs; ≥ 5\u002FµL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)\n* Contraception Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen.\n* Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous\u002Funknown effects on the fetus.\n* Ability to give informed consent. All subjects ≥ 18 years of age must be able to give informed consent. For subjects \\\u003C18 years old their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and verbal assent will be obtained for those \\> 7 years of age, when appropriate.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for participation in the study:\n\n* Recurrent or refractory ALL limited to isolated testicular.\n* Subjects with radiologically-detected CNS lymphoma or CNS 3 disease (presence of ≥ 5\u002FµL WBCs in CSF and cytospin positive for blasts \\[in the absence of a traumatic lumbar puncture\\] and\u002For clinical signs of CNS leukemia).\n* Hyperleukocytosis (≥ 50,000 blasts\u002FµL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.\n* History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n* Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* CNS disorder such as cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in the judgment of the investigator may impair the ability to evaluate neurotoxicity.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment, or have cardiac atrial or cardiac ventricular lymphoma involvement.\n* Subjects receiving anticoagulation therapy.\n* Any medical condition that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of study treatment\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning lymphodepletion chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.","2 Years","90 Years",{"count":114,"type":21},75,[116,56],"PHASE1","This is an open-label, single-arm, phase I clinical trial with dose escalation designed to investigate the safety, tolerability, and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion. The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsed\u002Frefractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II.\n\nEligible participants, including those with Central Nervous System Lymphoma, B Cell Lymphoma (BCL), Acute Lymphocytic Leukemia (ALL), Acute Lymphoblastic Leukemia (ALL), B Acute Lymphoblastic Leukemia (B-ALL), Refractory Non-Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia (CLL), Refractory B Acute Lymphoblastic Leukemia (B-ALL), Diffuse Large B Cell Lymphoma, Lymphoid Leukemia, and MRD-positive cases, can participate. Eligibility will be determined through a comprehensive assessment, including disease evaluations, a physical examination, Electrocardiograph, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and blood tests. Prior to the infusion of CD19-CD22 CAR+ T cells, participants will undergo chemotherapy. After the infusion, participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR+ T cells. Certain study procedures may be conducted during hospitalization.",[119,120,25,121,122,123,124],"Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, in Relapse","Diffuse Large B Cell Lymphoma","Central Nervous System Lymphoma","Lymphoma, Follicular","MCL",[122,126,127,128,121,129],"B Cell Lymphoma (BCL)","Acute Lymphocytic Leukemia (ALL)","Refractory Non-Hodgkin Lymphoma","MRD-positive cases","2025-08-05",{"date":132,"type":35},"2025-08-06",{"date":134,"type":35},"2024-07-10",{"date":136,"type":21},"2028-12-10",{"name":138,"class":42},"Essen Biotech",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":102},"100571541","an-extension-study-to-evaluate-the-safety-and-efficacy-of-an-anti-cd19-car-t-product-in-patients-with-b-cell-lymphoproliferative-disorders-100571541","NCT06721598","An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders","An Open-label, Non-interventional, Single-group Follow-up Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients with Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders","Inclusion Criteria:\n\n1. Successful completion of the HemC101-01-01 study procedures.\n2. Negative pregnancy test for women of reproductive potential.\n\nExclusion Criteria:\n\n1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed.\n2. The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials).\n3. Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results.\n4. Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.","71 Years",{"count":148,"type":21},60,"This follow-up study is designed to evaluate the long-term safety and effectiveness of a treatment called anti-CD19 CAR-T cell therapy in adults with certain B-cell blood cancers. These cancers include types that have returned after treatment or have not responded to other therapies. CAR-T cell therapy involves using a patient's own immune cells, which are modified in a lab to specifically target and destroy cancer cells with a marker called CD19. The study will look at how well patients tolerate this treatment over time, as well as its ability to keep cancer in remission or reduce its severity.\n\nPatients who have previously received CAR-T therapy in an earlier clinical trial and meet specific criteria can participate in this study. The research will include regular follow-up visits over approximately 11 months to monitor for side effects, assess cancer response, and track the activity of CAR-T cells in the body. This study does not involve additional treatments but focuses on understanding the long-term outcomes of CAR-T therapy to provide better care for patients in the future.",[25,151],"Acute Lymphoblastic Leukemia ALL",[89,153,154],"B-cell lymphoma","non-Hodgkin lymphoma","NOT_YET_RECRUITING","2024-12-03",{"date":158,"type":35},"2024-12-06",{"date":160,"type":21},"2025-01-09",{"date":162,"type":21},"2026-09-30",{"name":164,"class":165},"National Research Center for Hematology, Russia","NETWORK",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":54,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":155,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100540595","phase-1-a-first-in-human-study-of-sctb35-in-patients-with-relapserefractory-b-cell-non-hodgkin-lymphoma-100540595","NCT06318884","A First-in-human Study of SCTB35 in Patients With Relapse\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Phase Ia\u002FIb Dose-escalation and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SCTB35 in Patients With CD20+ Relapse\u002FRefractory B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\nPatients are eligible to be included in the study only if all the following conditions are met:\n\n1. Age ≥ 18 years\n2. Histologically or cytologically confirmed CD20+ mature B-cell neoplasm\n\n   For dose-escalation phase:\n   1. De novo or transformed diffuse large B-cell lymphoma (DLBCL)\n   2. High-grade B-cell lymphoma (HGBCL)\n   3. Primary mediastinal large B-cell lymphoma (PMBCL)\n   4. Follicular lymphoma (FL)\n   5. Mantle cell lymphoma\n   6. Small lymphocytic lymphoma (SLL)\n   7. Marginal zone lymphoma (MZL) (nodal, extranodal or mucosa associated)\n\n   For dose expansion phase:\n   1. FL cohort: histologic confirmed FL grade 1, 2, or 3a at initial diagnosis without clinical or pathological evidence of transformation\n   2. LBCL cohort: including histologic confirmed DLBCL, not otherwise specified (NOS), Epstein-Barr virus+ DLBCL, transformed DLBCL from indolent subtypes, HGBCL, NOS, double\u002Ftriple-hit HGBCL, FL grade 3b, and PMBCL\n3. For dose-escalation phase:\n\n   Relapsed, progressive and\u002For refractory disease after adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)\n   1. Patients must have exhausted or are ineligible for all standard therapeutic options\n   2. Patients with indolent lymphoma (FL, MZL or SLL) must have a need for treatment initiation based on symptoms and\u002For disease burden\n\n   For dose-expansion phase:\n\n   Relapsed, progressive and\u002For refractory disease following ≥ 2 prior lines of adequate systemic therapy containing at least an anti-CD20 monoclonal antibody (e.g. rituximab)\n4. At least 1 measurable site of disease based on computed tomography (CT) or magnetic resonance imaging (MRI) (defined as a clearly nodal lesion with the long axis \\> 1.5 cm or extranodal lesion with the long axis \\> 1.0 cm). Lesions that have previously received radiotherapy can be considered measurable only after confirming the presence of progression or residual lesions. (for the dose-escalation phase: a evaluable site of disease is allowed).\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n6. Adequate hepatic\u002Fhematologic\u002Frenal\u002Fcardiac functions indicated by laboratory values\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL within 7 days before first dose of study drug (without growth factor support). There is an exception for patients with bone marrow involvement in which case ANC must be ≥ 0.75 x 10\\^9\u002FL\n   2. Platelets \\> 75 x 10\\^9\u002FL within 7 days before first dose of study drug (without growth factor support or transfusion). There is an exception for patients with bone marrow involvement in which case platelets must be ≥ 50 x 10\\^9\u002FL\n   3. Hemoglobin \\> 90 g\u002FL within 7 days before first dose of study drug (independent of growth factor support or transfusion).\n   4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45 mL\u002Fmin as estimated by Cockcroft-Gault equation\n   5. Adequate liver function indicated by: i) Aspartate aminotransferase (AST)\u002Fserum glutamic-oxaloacetic transaminase ≤ 3 x ULN; ii) Alanine aminotransferase (ALT)\u002Fserum glutamic-pyruvic transaminase ≤ 3 x ULN; iii) Total bilirubin level ≤ 1.5 x ULN (unless documented Gilbert's syndrome).\n   6. Left ventricular ejection fraction ≥ 50%;\n7. Expected survival time is more than 3 months\n\nExclusion Criteria:\n\nA patient who conforms to any of the following criteria should be excluded from the study:\n\n1. Any prior therapy with an bispecific antibody of the same class\n2. Eligible for high dose chemotherapy with hematopoietic stem cell transplantation (HSCT)\n3. Known central nervous system (CNS) involvement by lymphoma\n4. Known past or current malignancy other than inclusion diagnosis, with the following exceptions:\n\n   1. Cervical carcinoma of Stage Ib or less\n   2. Non-invasive basal cell or squamous cell skin carcinoma\n   3. Non-invasive, superficial bladder cancer\n   4. Prostate cancer with a current prostate-specific antigen (PSA) level \\\u003C0.1 ng\u002FmL\n   5. Any curable cancer with a complete response (CR) of \\>2 years duration\n5. Known clinically significant cardiac disease, including:\n\n   1. Onset of unstable angina pectoris or acute myocardial infarction within 6 months prior to signing Informed Consent Form (ICF)\n   2. Congestive heart failure prior to signing ICF (meets the criteria of New York Heart Association Classification III or IV)\n   3. Clinically significant arrhythmia prior to signing ICF\n6. History of interstitial lung disease or uncontrolled lung diseases, or evidence of dyspnea at rest or pulse oximetry \\\u003C 93% while breathing room air.\n7. Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy (including \\>20mg\u002Fday prednisolone \\[or equivalent\\], but low-dose prednisolone is allowed). The well controlled autoimmune disease can be enrolled at investigator's discretion, including:\n\n   1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n   2. Patients with a history of type 1 diabetes mellitus who were well controlled (defined as a screening hemoglobin A1c \\\u003C 8% and no urinary ketoacidosis)\n   3. Patients with skin disease who were not treated with systemic corticosteroid\n8. History of seizure disorder or confirmed progressive multifocal leukoencephalopathy (PML)\n9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n10. Known any major episode of active infection requiring treatment with systemic antibiotics within 2 weeks prior to signing ICF\n11. Positive for human immunodeficiency virus (HIV) antibody. Positive for hepatitis B antibody (except for only the positive HBsAb) with detectable hepatitis B virus (HBV) DNA. Positive for hepatitis C antibody with detectable hepatitis C virus (HCV) RNA\n12. Chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to first SCTB35 administration (only applicable for dose-expansion phase)\n13. Autologous HSCT within 100 days prior to first SCTB35 administration, or any prior allogeneic HSCT or solid organ transplantation\n14. Received major surgery within 4 weeks prior to first SCTB35 administration, or planned to receive major surgery during the study\n15. Received any chemotherapeutic agent, other anti-cancer agent, or investigational drug (monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first SCTB35 administration\n16. Exposed to live or live attenuated vaccine within 4 weeks prior to first SCTB35 administration, or planned to receive these vaccines during the study\n17. Pregnancy or breast feeding. During the study and for 6 months after last administration of SCTB35, a woman of childbearing potential or a man who is sexually active with a woman of childbearing potential disagrees to practice a highly effective method of birth control.\n18. Patient has any condition for that, in the opinion of the investigator, participation could prevent, limit, or confound the protocol-specified assessments",{"count":174,"type":21},76,[116],"This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and\u002For refractory B-cell non-Hodgkin lymphoma.",[25],[27],"2024-03-20",{"date":181,"type":35},"2024-03-22",{"date":183,"type":21},"2024-04",{"date":185,"type":21},"2027-12",{"name":187,"class":72},"Sinocelltech Ltd.",3]