[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mcl":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,73,99,124,159],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100569664","phase-1-a-study-to-investigate-the-safety-of-novel-dose-ramp-up-schedules-when-initiating-sonrotoclax-in-participants-treated-for-blood-cancers-100569664",false,"NCT06697184","A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Participants Treated for Blood Cancers.","A Phase 1\u002F2 Open-label Study to Investigate the Safety of Sonrotoclax Ramp-up Schedule(s) in Adult Patients With Hematological Malignancies.","Inclusion Criteria:\n\n1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.\n2. Adequate organ function and no very recent transfusion or blood growth factor\n3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later.\n\n   Only for participants with Chronic Lymphocytic Leukemia (CLL):\n4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease\n5. At least 1 measurable lesion based on computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation.\n\n   Only for participants with Mantle cell lymphoma (MCL):\n6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC).\n7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation.\n8. Measurable disease defined as ≥ 1 nodal lesion that is \\> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \\> 1 cm in longest diameter.\n\nExclusion Criteria:\n\n1. Participants unable to comply with the requirements of the protocol\n2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n3. Positive HIV serology (HIVAb) status unless certain conditions are met.\n4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment\n5. Prior systemic treatment for the CLL\n6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment\n7. Prior exposure to a BCL-2 inhibitor\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},258,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.",[27,28,29,30],"Chronic Lymphocytic Leukemia","CLL","Mantle Cell Lymphoma","MCL",[32,33],"CLL previously untreated","Hematological Malignancies","RECRUITING","2026-06-05",{"date":37,"type":38},"2026-06-08","ACTUAL",{"date":40,"type":38},"2025-01-23",{"date":42,"type":20},"2032-11-30",{"name":44,"class":45},"BeOne Medicines","INDUSTRY",17,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100612705","phase-2-phase-2-study-of-btki-rituximab-induction-followed-by-glofitamab-consolidation-in-high-risk-untreated-mcl-patients---window-4-study-100612705","NCT07257055","Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study","Eligibility Criteria\n\nParticipants must meet the following criteria for study entry:\n\n1. Confirmed diagnosis of mantle cell lymphoma by hematopathology. MCL should have CD20 positivity (by flow or IHC in tissue or in BM) with presence of chromosome translocation t (11;14), (q13;q32) and\u002For overexpression of cyclin D1 in tissue biopsy. Cyclin D negative MCL are allowed after discussion with study PI.\n2. Participants should have a life expectancy \\>= 12 weeks.\n3. Newly diagnosed, untreated, high risk participant without any prior therapy for MCL and are eligible to receive BTKi-R and glofitamab therapy.\n4. High risk MCL (Blastoid\u002Fpleomorphic histology, high Ki-67 (≥50%), TP53\u002FNOTCH1\u002F2, NSD2, UBR5, TRAF2, SP140, SMARCA4, KMT2D, BIRC3 mutated or any of these mutations or more than 2 mutations with some evidence of prognostic impact, complex karyotype and\u002For Bulky nodal disease \\>= 5 cm or spleen \\>= 20 cm, FISH positive for TP53 or MYC from involved tissues or TP53 and MYC positive intensity in lymphoma cells in involved tissues (positive by hem-path criteria at MDACC), high risk MIPI score (with\u002Fwithout Ki-67%). Presence of any or all of these features would qualify as high risk but will need to be reviewed and approved by the study PI.\n\n6\\. Participants who are willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.\n\n7\\. Understand and voluntarily sign an IRB-approved informed consent form. 8. Age ≥ 18 years at the time of signing the informed consent. 9. Bi-dimensional measurable disease using the 2014 Cheson criteria (Measurable disease by PETCT scan or CT scan (if PET-CT not approved and study PI approves) defined as at least 1 lesion that measures ≥ 1.5 cm in single dimension.) and\u002For spleen only involved (\\>=20 cm). Leukemic phase MCL are allowed without bulky measurable disease if they have other high-risk features after discussion with the study PI. These participants are allowed if they meet any other high-risk features, determined by the study PI.\n\n10\\. Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less. 11. Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, antihypertensive, prior ablation, anti-arrhythmia, prior arrhythmias, baseline EKG abnormalities and cardiology clearance are allowed. Ejection fraction \\>=50% and cardiology evaluation is needed. (Echo and EKG and cardiology consultation within 2 months prior to C1D1 are allowed).\n\n12\\. An absolute neutrophil count (ANC) \\> 1,000\u002Fmm3 and platelet count \\>100,000\u002Fmm3 (Participants who have \\>50% bone marrow or spleen infiltration by MCL are eligible if their ANC is ≥ 500\u002Fmm3 \\[growth factor allowed\\] or their platelet level is equal to or \\>= than 30,000\u002Fmm3 (transfusions allowed) These participants should be discussed with the PI of the study for final approval). Hemoglobin \\> 8.0 g\u002FdL (\\> 80 g\u002FL), unsupported for 2 days before first treatment (unless attributable to the underlying disease as determined by the study PI) 13. Serum bilirubin \\\u003C1.5 mg\u002Fdl, AST (SGOT) and ALT (SGPT) \\\u003C 2.5 x upper limit of normal or \\\u003C 5 x upper limit of normal if hepatic metastases are present. Gilbert's disease is allowed.\n\n14\\. Creatinine clearance. \\>=30 mL\u002Fmin (by 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation or 2021 CKD-EPI creatinine-cystatin C equation., APPENDIX VI I) 15. Contraception in female participants of childbearing potential- female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab and 2 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period.\n\n16\\. A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (³ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\n17\\. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation in female of child-bearing potential, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n18\\. Hormonal contraceptive methods are also recommended to be supplemented by a barrier method.\n\n19\\. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\n20\\. Contraception for male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below: 21. With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period.\n\n22\\. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. ..\n\na. Females must agree to abstain from breastfeeding during study participation and for at least 12 months after glofitamab discontinuation. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test. WOCBP and males must be willing to use highly effective methods of birth control. Woman of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and 1 week after the last dose of acalabrutinib b. Females of childbearing potential (FCBP§ ) must: i. Have one negative pregnancy tests via serum in some cases urine (as clinically indicated) one week or immediately prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, prior to day 1 of each cycle, and after end of study therapy. This applies even if the subject practices true abstinence\\* from heterosexual contact.\n\nii. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice. Otherwise, she must agree to use, and be able to comply with highly effective contraception.\n\nc. Male subjects must: i. A male subject who is sexually active with a female with reproductive potential is also recommended to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F suppository (including dose interruptions), even if they have undergone a successful vasectomy, from the time of signing consent and for at least 2 months after the last dose of glofitamab, 6 months after treatment with obinutuzumab, or 2 months after the last dose of tocilizumab (if applicable), whichever is longer. For male participants with a pregnant or non-pregnant WOCBP partner, should use barrier contraception, during treatment and for 1 week after the last dose of acalabrutinib, 180 days following the last dose of rituximab, 2 months following the last dose of glofitamab,6 months following the last dose of obinutuzumab, 2 months following the last dose of tocilizumab (if applicable), , whichever is longer, even if they have had a successful vasectomy.) d. Participant must be willing and able to comply with protocol-mandated hospitalization upon administration of the first dose of glofitamab. e. f. Have achieved complete metabolic response by Lugano criteria\\[35\\] to go to part 2 for glofitamab consolidation g. Performance status ≤1 on the ECOG scale h. All subjects must i. Agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 12 months following the last dose of study treatment.\n\nExclusion Criteria Having radiologically confirmed relapsed\u002Frefractory disease.\n\n1. Isolated bone marrow or GI only disease MCL participants and\u002For lack of any measurable disease, except if participants have leukemic phase MCL with any high risk features.\n2. Pregnant or breast-feeding females.\n3. Participants who are primary refractory to BTKi-R (No response\u002Fprogressive disease within first 3 months of BTKi-R)\n4. Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.\n5. Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.\n6. Known HIV infection.\n7. Known history of hemophagocytic lymphohistiocytosis (HLH)\n8. Known or suspected chronic active Epstein-Barr virus infection (clearance with infectious disease is needed to allow these participants)\n9. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.\n10. Participants who do not meet high risk features as indicated above in inclusion.\n11. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B PCR positive will be excluded (unless cleared by hepatology and ID team after discussion with study PI). Subjects who are hepatitis C antibody positive will need to have a negative PCR result to be eligible. Those who are hepatitis C PCR positive will be excluded.\n12. Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ ca prostate, in situ melanoma (\\> 5 mm margins) or other cancer from which the subject has been disease free for ≥ 3 years or which will not limit survival to \\\u003C 3 years or not on active systemic chemotherapy.\n13. Central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML). Magnetic resonance imaging (MRI) of the brain, if performed, showing evidence of central nervous system (CNS) lymphoma or Lumbar puncture with flow cytometry, if performed, with CSF involvement.\n14. History or presence of uncontrolled CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, cerebral edema, posterior reversible encephalopathy syndrome, or any autoimmune disease with CNS involvement.\n15. Active bleeding, history of bleeding diathesis (such as Hemophilia or Von-Willebrand disease), Any history of intracranial bleed or stroke within 6 months of first dose of study drug.\n16. Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).\n17. Malabsorption syndrome, disease which is clinically significantly affecting gastrointestinal function, or resection of the stomach or small bowel or active ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction, or any other gastrointestinal condition that could interfere with the absorption and metabolism of BTKi. These participants may be allowed after discussion, clearance with GI team and discussion with the study PI.\n18. Presence of a clinically significant gastrointestinal ulcer diagnosed by endoscopy within 3 months before first dose of study drug.\n19. Requires anticoagulation with warfarin or equivalent vitamin K antagonist, active treatment for pulmonary embolism (PE)\u002F deep vein thrombosis (DVT) and persons with mechanical cardiac valves. These participants may be allowed after review with benign hematology and study PI.\n20. Concomitant use of corticosteroids at \\> 20 mg prednisone or equivalent per day longer than 2 weeks.\n21. Primary immunodeficiency which is clinically active\n22. History of confirmed autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years. Rheumatology clearance and approval by study PI is required for pts with remote history of auto-immune disease.\n23. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited.\n24. Requires treatment with strong CYP3A inhibitors or inducers.\n25. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification. Subjects with controlled, asymptomatic heart failure during screening can enroll on study and\u002For any of the following cardiac related conditions, unless cleared by cardiology and study PI:\n26. NYHA Class III and IV heart failure,\n27. Active\u002Fsymptomatic coronary artery disease,\n28. Myocardial infarction in the preceding 6 months,\n29. Significant conduction abnormalities, including but not limited to:\n30. Left bundle branch block,\n31. 2nd degree AV block type II,\n32. 3rd degree block,\n33. QT prolongation (QTc \\> 500 msec),\n34. Sick sinus syndrome,\n35. Ventricular tachycardia,\n36. Symptomatic bradycardia (heart rate \\\u003C 50 bpm),\n37. Persistent and uncontrolled atrial fibrillation.\n38. Uncontrolled hypertension\n39. Uncontrolled Hypotension\n40. Light headedness and syncope,\n41. Acute infection requiring systemic anti-infective treatment systemic antibiotics, antivirals, or antifungals, or including subjects with positive cytomegalovirus \\[CMV\\] DNA polymerase chain reaction \\[PCR\\] within 14 days prior to initiation of therapy. Participant who exhibit active uncontrolled infection on BTKi-R alone will not be excluded but would await adequate infection control and then get CAR T, as long as they have evidence of disease.\n42. Vaccinated with live, attenuated vaccines within 6 weeks of first dose of study drug.\n43. Any other serious medical condition including, but not limited to, clinically significant uncontrolled diabetes mellitus, COPD, renal failure, psychiatric illness or social circumstances that, in the investigator's opinion places the participant at unacceptable risk and would prevent the participant from signing the informed consent form or complying with study procedures.\n44. Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components.\n\n6\\. Concurrent participation in another therapeutic clinical trial. 47. Is unable to swallow any oral medication or has clinically significant gastrointestinal disease thatwould limit absorption of oral medication.\n\n48\\. . 49. Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug.\n\n50\\. Participants with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (antiHBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.\n\n1. History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.\n2. History of immunodeficiency (except for hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \\>10mg\u002Fday of prednisone) within 28 days of the first dose of study drug with exception of steroid used for IV contrast allergy. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (eg, intra- articular injection) is permitted.",{"count":54,"type":20},30,[24],"to learn if giving glofitamab after treatment with BTKi-rituximab can help to control high-risk MCL.",[58,30,59,60,61],"Phase 2 Study","BTKi","Rituximab","Glofitamab","2026-05-18",{"date":64,"type":38},"2026-05-20",{"date":66,"type":38},"2026-04-01",{"date":68,"type":20},"2030-11-24",{"name":70,"class":71},"M.D. Anderson Cancer Center","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":72},"100612860","phase-1-multicenter-single-arm-exploratory-phase-i-clinical-study-assessment-of-safety-and-efficacy-of-fully-human-baff-r-chimeric-antigen-receptor-t-cell-injection-in-relapsedrefractory-baff-r-positive-b-cell-lymphoma-100612860","NCT07259070","Multicenter, Single-Arm Exploratory Phase I Clinical Study (Assessment of Safety and Efficacy) of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Multicenter, Single-Arm Exploratory Phase I Clinical Study on the Safety and Efficacy of Fully Human BAFF-R Chimeric Antigen Receptor T-Cell Injection in Participants With Relapsed\u002FRefractory BAFF-R-Positive B-Cell Lymphoma","Inclusion Criteria:\n\n1.Relapsed and refractory (R\u002FR) BAFF-R-positive B-cell lymphoma:The diagnosis of B-cell lymphoma must be confirmed in accordance with the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (Version 1.2020) (NCCN: National Comprehensive Cancer Network).The expression of BAFF-R on tumor cells must be detected by flow cytometry (for patients where current clinical sampling is not feasible, test results obtained within 90 days prior to signing the informed consent form are acceptable). Investigators will determine whether to accept test results from external hospitals and whether the patient is eligible for enrollment.In accordance with the 2014 Lugano Classification, B-cell lymphoma patients must have at least one measurable lesion with a longest diameter ≥ 1.5 cm, or bone marrow involvement confirmed by bone marrow flow cytometry.Patients who have received CD19-targeted therapy are also eligible for enrollment, including those who have undergone:\n\n1. :Relapsed and refractory (R\u002FR) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor \\[BTKi\\]).\n2. :Relapsed and refractory (R\u002FR) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.\n3. :Relapsed and refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.\n4. :Relapsed and refractory (R\u002FR) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n5. :Relapsed and refractory (R\u002FR) marginal zone lymphoma (MZL):Histologically confirmed MZL;Patients who have received anti-CD20 monoclonal antibody-containing therapy, have undergone at least 2 lines of treatment in total and relapsed thereafter; or patients who relapsed within 24 months after initial treatment.\n6. :Relapsed and refractory (R\u002FR) Waldenström macroglobulinemia (WM):Histologically confirmed WM;Patients who have received anti-CD20 monoclonal antibody-containing therapy and BTK inhibitor-containing therapy (among other medications), and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.\n\n2.Aged ≥ 18 years and ≤ 75 years, with no restriction on gender. 3.Expected survival time ≥ 12 weeks. 4.Serum total bilirubin ≤ 37.2 μmol\u002FL (for patients with Gilbert syndrome: serum total bilirubin ≤ 3.0 × upper limit of normal \\[ULN\\], direct bilirubin ≤ 1.5 × ULN); estimated glomerular filtration rate \\[eGFR\\] (calculated by CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m²; alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] \\\u003C 2.5 × upper limit of normal \\[ULN\\].\n\n5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6.Left ventricular ejection fraction (LVEF) ≥ 50% as diagnosed by echocardiography; oxygen saturation \\> 91%.\n\n7.The participant and their spouse\u002Fpartner must agree to use effective barrier or pharmaceutical contraceptive methods from the time the participant signs the informed consent form until one year after CAR-T cell infusion. For female participants of childbearing potential, serum or urine pregnancy test results must be negative during the screening period.\n\n8.Voluntarily participate in this trial and sign the Informed Consent Form (ICF).\n\n1. ： The patient has a full understanding of this study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).\n2. ：Aged ≥ 18 years and ≤ 75 years, with no restriction on gender.\n\nExclusion Criteria:\n\n1. Patients with a history of allergy to any component of the cellular product.\n2. Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.\n3. Participants who have received a live vaccine injection within 4 weeks prior to enrollment.\n4. Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.\n5. Patients with severe active infections (except uncomplicated urinary tract infections and bacterial pharyngitis), or those currently receiving intravenous antibiotic therapy. However, prophylactic use of antibiotics, antiviral drugs, and antifungal drugs is permitted.\n6. Patients who are positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B virus (HBV) DNA in peripheral blood.\n7. Patients who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood.\n8. Patients with other acquired or congenital immunodeficiency diseases, including but not limited to those positive for human immunodeficiency virus (HIV) antibody; patients with cytomegalovirus (CMV) DNA test value \\> 400 copies\u002FmL; patients with positive syphilis test results.\n9. Patients with heart failure classified as Grade III or IV according to the New York Heart Association (NYHA) Functional Classification (see Appendix II).\n10. Patients with a history of other primary malignancies, except for the following cases:Non-melanoma skin cancer (e.g., basal cell carcinoma of the skin) cured by resection;In situ carcinoma cured (e.g., cervical cancer, bladder cancer, breast cancer, etc.);Other primary malignancies with no recurrence detected for more than 5 years after treatment.\n11. Patients with a history of solid organ transplantation.\n12. Patients with a history of autoimmune diseases (predominantly characterized by abnormal cellular immunity), as well as patients with immunodeficiency or those requiring immunosuppressive therapy.\n13. Patients who received investigational drugs from other interventional clinical trials within 3 months prior to signing the Informed Consent Form (ICF).\n14. Pregnant women or women who are breastfeeding.\n15. Patients with psychiatric disorders, consciousness disturbances, or central nervous system (CNS) diseases.\n16. Patients whose toxic effects from prior treatment have not resolved to baseline or ≤ Grade 2 (per NCI-CTCAE Version 5.0, alopecia excluded).\n17. Medication use:Corticosteroids: Use of therapeutic-dose corticosteroids within 72 hours prior to CAR-T cell infusion; however, physiological-dose corticosteroid replacement is permitted (hydrocortisone \\\u003C 12 mg\u002Fm²\u002Fday or its equivalent dose)；Systemic antineoplastic therapy: Failure to discontinue systemic antineoplastic therapy for at least 2 weeks or 5 drug half-lives prior to T cell apheresis (except for BTK inhibitors in patients with CLL); the interval between T cell apheresis and the use of immune checkpoint inhibitors is less than 3 drug half-lives.\n18. Patients with active pulmonary infections.\n19. Patients with contraindications to peripheral blood apheresis.\n20. Patients deemed unsuitable for participation in this trial by the investigator after careful consideration for other reasons.","75 Years",{"count":82,"type":20},20,[23,24],"The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).\n\nThe secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed\u002Frefractory BAFF-R-positive B-cell lymphoma.\n\nThe study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.",[86,28,87,30,88,89],"DLBCL","FL","WM","MZL","2026-05-10",{"date":92,"type":38},"2026-05-13",{"date":94,"type":38},"2025-11-29",{"date":96,"type":20},"2029-11-28",{"name":98,"class":71},"Institute of Hematology & Blood Diseases Hospital, China",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":72},"100628340","phase-2-glofitamab-combined-with-lenalidomide-in-high-risk-patients-with-relapsed-or-refractory-mantle-cell-lymphoma-100628340","NCT07460362","Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma","A Single-arm, Open-label, Multi-center Clinical Study of Glofitamab Combined With Lenalidomide in High Risk Patients With Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With a BTK Inhibitor","Inclusion Criteria:\n\n* • Signed Informed Consent Forms\n\n  * Age: \\>= 18 to 80 years\n  * Eastern Cooperative Oncology Group =\\\u003C 2\n  * Diagnosis of MCL established by histologic assessment\n  * Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma.\n  * Prior therapy have included a BTK inhibitor, including ibrutinib, zanubrutinib, obrutinib, acalabrutinib and various BTKi in clinical trials. BTki exposure is required, which include BTKi failure or intolerance. BTKi failure is defined as progression of disease during BTKi therapy or patients have progressed or relapsed after completing BTK inhibitor therapy\n  * At least one high risk features as classified:\n\n    * Blastoid\u002Fpleomorphic variants ✔ Ki67 ≥50% ✔ TP53 mutation or deletion\n    * Bulky disease (defined as any lesion ≥7.5 cm on the screening computed tomography \\[CT\\] scan）\n    * Patients that did not achieve a CR with their first-line treatment\n    * early disease progression (POD24) ✔ patients with relapse and refractory treatment above 3 lines\n  * Measurable lesions on cross-sectional imaging documented by diagnostic imaging(MRI, CT or PET-CT), （GTD）≥1.5 cm\n  * Adequate liver function : Total bilirubin =\\\u003C 3 x upper limit of normal (ULN) (unless has Gilbert's disease), Aspartate aminotransferase (AST) =\\\u003C 5.0 x ULN, Alanine aminotransferase (ALT) =\\\u003C 5.0 x ULN\n\nExclusion Criteria:\n\n* • Already enrolled in other Ongoing interventional or non-interventional R\u002FR MCL clinical trials;\n\n  * Currently receiving immunosuppressive treatment for other diseases;\n  * Previous treatment with lenalidomide;\n  * Combined with other malignant tumors within 3 years;\n  * The researcher determines that they are not suitable to participate in this study;\n  * Serious mental or neurological disorders that affect informed consent and\u002For the expression or observation of adverse reactions;\n  * Have a history of major or extensive cardiovascular disease, such as New York Heart Association class III or Grade IV heart disease or objective assessment, myocardial infarction, unstable arrhythmia or unstable angina within 6 months before the first cycle;\n  * Recent major surgery (within 4 weeks before the start of the first cycle);\n  * Active autoimmune diseases with poor treatment control;\n  * Any active infection that may affect the safety of the participant, including bacterial, fungal and various viral infections, occurred within 7 days before the first day of cycle 1;\n  * Positive SARS-CoV-2 PCR test within 7 days prior to enrollment\n  * Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n  * Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n  * A history of severe deep vein thrombosis event or pulmonary embolism within 6 months\n  * Patient follow-up was not possible.","80 Years",{"count":108,"type":20},43,[24],"A single-arm, open-label, multi-center clinical study of glofitamab combined with lenalidomide in high risk patients with relapsed or refractory Mantle Cell Lymphoma previously treated with a BTK Inhibitor.\n\nPatients will be eligible if they have received one or more prior lines of therapy, one of which must have been a BTKi. Patients will be enrolled according to a Simon two-stage design, with early stop criteria for lack of efficacy.\n\nGlofitamab will be administered intravenously and lenalidomide will be self-administered orally.\n\nObinutuzumab pretreatment will be administered intravenously as 2 doses of 1000 mg prior to glofitamab initiation. The primary endpoint is BOR at the end of induction, evaluated by PET\u002FCT according to Lugano criteria during study enrolment.\n\nThe primary objective is to evaluate the best objective response rate (BOR) at the end of induction of the combination of glofitamab and lenalidomide.",[30,112],"Relapsed or Refractory Mantle Cell Lymphoma (MCL)",[114],"Relapsed or Refractory MCL, previously treated with a BTK Inhibitor","2026-03-05",{"date":117,"type":38},"2026-03-10",{"date":119,"type":38},"2025-08-11",{"date":121,"type":20},"2029-12-30",{"name":123,"class":71},"Peking University Third Hospital",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":145,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":72},"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":135,"type":20},75,[23,24],"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.",[139,140,141,142,143,144,30],"Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, in Relapse","Non-Hodgkin Lymphoma, B-cell","Diffuse Large B Cell Lymphoma","Central Nervous System Lymphoma","Lymphoma, Follicular",[143,146,147,148,142,149],"B Cell Lymphoma (BCL)","Acute Lymphocytic Leukemia (ALL)","Refractory Non-Hodgkin Lymphoma","MRD-positive cases","2025-08-05",{"date":152,"type":38},"2025-08-06",{"date":154,"type":38},"2024-07-10",{"date":156,"type":20},"2028-12-10",{"name":158,"class":71},"Essen Biotech",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":72},"100551715","phase-2-sonrotoclax-zanubrutinib-and-cd20mab-in-untreated-mcl-patients-100551715","NCT06463691","Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients","An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients","Inclusion Criteria:\n\n1. Subject must be ≥ 18 years of age.\n2. Subject must have a confirmed Mantle Cell Lymphoma (MCL) diagnosis according to WHO (2008) criteria.\n3. Previously untreated MCL\n4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.\n5. Nonsterile men and women of child-bearing potential must agree to use highly effective contraceptives (e.g., condoms, implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence, or sterilized partner) while on study; this should be maintained for 90 days after the last dose of study drug.\n6. Subject must have adequate bone marrow function at Screening as follows:\n\n   a.Absolute Neutrophil Count (ANC) ≥ 1.0 x 109\u002FL (neutropenia due to marrow infiltration may be supported by growth factors);\n\n   • b. Platelets ≥ 75,000\u002Fmm3 (or ≥ 50,000\u002Fmm3 for patients with bone marrow involvement of lymphoma) within 7 days\n7. Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:\n\n   1. aPTT and PT not to exceed 1.5 × the upper limit of normal (ULN); Serum creatinine not to exceed 2 x ULN, and a calculated creatinine clearance of at least 50 mL\u002Fmin using the Cockcroft-Gault equation or a 24-hour urine collection;\n   2. AST or ALT ≤ 3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin ≤ 1.5 × ULN. Subjects with documented Gilbert's Syndrome may have a bilirubin \\> 1.5 × ULN.\n8. Written informed consent form according to GCP and national regulations.\n\nExclusion Criteria:\n\n1. Subject has known central nervous system involvement by MCL.\n2. Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer.\n3. Receiving any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inhibitor or inducer within 2 weeks (or 5 half-lives, whichever is longer) before the first dose of study drug or requiring long-term use of strong CYP3A4 inhibitors or inducers.\n4. Prior ASCT within the last 3 months; or prior autologous chimeric antigen receptor-T cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants.\n5. Major surgery within 4 weeks of screening.\n6. Clinically significant cardiovascular disease including the following:\n\n   1. Myocardial infarction within 6 months before screening\n   2. Unstable angina within 3 months before screening\n   3. New York Heart Association class III or IV congestive heart failure\n   4. History of clinically significant arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation)\n   5. QT interval corrected based on Fridericia's formula (QTcF) \\> 480 msec.\n   6. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place\n   7. Uncontrolled hypertension as indicated by a minimum of 2 consecutive blood pressure measurements showing systolic blood pressure \\> 170 mmHg and diastolic blood pressure \\> 105 mmHg at screening.\n7. Prior exposure to a BCL2 inhibitor (e.g., venetoclax\u002FABT-199).\n8. Prior exposure to a BTK inhibitor (e.g., ibrutinib, zanubrutinib).\n9. History of hypersensitivity to excipient(s) of the sonrotoclax tablet.\n10. Patients with unresolved hepatitis B or C infection or known HIV-positive infection：\n\n    1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (\\\u003C 20 IU\u002FmL), and if they are willing to undergo monitoring for HBV reactivation.\n    2. Presence of hepatitis C virus (HCV) antibody. Patients with presence of HCV antibody are eligible if HCV RNA is undetectable (\\\u003C 15 IU\u002FmL), and if they are willing to undergo monitoring for HCV reactivation.\n11. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n12. Pregnant or lactating women.\n13. History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.\n14. Underlying medical conditions that, in the investigator's opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.",{"count":54,"type":20},[24],"This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.",[30],[30,171,172],"Sonrotoclax","Zanubrutinib","2025-05-08",{"date":175,"type":38},"2025-05-11",{"date":177,"type":38},"2024-08-01",{"date":179,"type":20},"2029-07",{"name":181,"class":71},"Tianjin Medical University Cancer Institute and Hospital"]