[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-malignancy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-malignancy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,40,72,93,127,140,172,195,223],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053427","phase-1-phase-i-study-of-hrs-1635-in-b-cell-malignancies-100053427",false,"NCT07583212","Phase I Study of HRS-1635 in B-cell Malignancies","An Open-Label, Multicenter Phase I Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-1635 in Patients With B-Cell Malignancies.","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n3. Expected survival time ≥ 12 weeks;\n4. Histologically or cytologically confirmed relapsed\u002Frefractory B-cell malignant tumor;\n5. Females of childbearing potential and male participants whose partners are females of childbearing potential must agree to adopt adequate and effective contraceptive measures during the study period. Female participants must not be breastfeeding;\n6. Participants voluntarily enroll in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n1. Tumor infiltration of the central nervous system;\n2. A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug;\n3. A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n4. Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test;\n5. Positive for hepatitis C virus antibody (HCV-Ab) at screening with evidence of viral replication confirmed by HCV-RNA test;\n6. Positive for human immunodeficiency virus (HIV) antigen\u002Fantibody test at screening;\n7. History of major surgery or severe trauma within 28 days prior to the first administration of the study drug;\n8. Presence of severe cardiovascular disease.;\n9. Persistent alcohol or drug abuse;\n10. Inability to take oral medication, or presence of severe gastrointestinal dysfunctional diseases, or history of surgery with severe impact on gastrointestinal function.\n11. Pregnant or lactating females.\n12. Concurrent participation in other interventional clinical trials, or an interval of less than 1 month between the signing date of the informed consent form and the last administration of the study drug in the previous clinical trial;","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.",[26],"B-cell Malignancy","RECRUITING","2026-07-09",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-06-30",{"date":35,"type":20},"2029-12",{"name":37,"class":38},"Chengdu Suncadia Medicine Co., Ltd.","INDUSTRY",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100439778","phase-1-a-dose-escalation-and-expansion-study-of-bgb-16673-in-participants-with-b-cell-malignancies-100439778","NCT05006716","A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies","CaDAnCe-101","Inclusion Criteria :\n\n1. Confirmed diagnosis (per World Health Organization (WHO) guidelines, unless otherwise noted) of one of the following: Marginal Zone Lymphoma (MZL), R\u002FR follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL\u002FSLL), Waldenström macroglobulinemia (WM), R\u002FR diffuse large B-cell lymphoma (DLBCL), or Richter's transformation to DLBCL.\n2. Participants who have previously received a covalently-binding Bruton´s tyrosine kinase (BTK) inhibitor (BTKi) in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).\n3. For dose-finding and dose-expansion, participants who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.\n4. Phase 2 Cohorts in R\u002FR CLL\u002FSLL, R\u002FR MCL, and R\u002FR WM only: Participants who previously received a BTKi are eligible if they had disease progression on only one regimen containing a covalent BTKi. Note: Participants may have received treatment with ≥ 2 different covalent BTKis if additional BTKis were discontinued secondary to an event other than disease progression.\n5. Measurable disease by radiographic assessment or serum IgM level (WM only)\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n7. Participants enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; participants with MCL enrolling in the expansion cohorts (Phase 2) must have been treated with a BTKi in a prior line of therapy; CLL\u002FSLL participants, in addition to being treated with a BTKi in a prior line of therapy, must also have received a Bcl-2 inhibitor in a prior line of therapy as well (Phase 2).\n\nExclusion Criteria:\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.\n2. Requires ongoing systemic treatment for any other malignancy\n3. Requires ongoing systemic (defined as ≥ 10 mg\u002Fday of prednisone or equivalent) corticosteroid treatment.\n4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease\n5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":49,"type":20},645,[23,51],"PHASE2","Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)",[26,54,55,56,57,58,59,60,61],"Marginal Zone Lymphoma","Follicular Lymphoma","Non-Hodgkin Lymphoma","Waldenström Macroglobulinemia","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Mantle Cell Lymphoma","Diffuse Large B Cell Lymphoma","2026-06-17",{"date":64,"type":31},"2026-06-18",{"date":66,"type":31},"2021-09-13",{"date":68,"type":20},"2029-11",{"name":70,"class":38},"BeOne Medicines",127,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":39},"100635756","phase-1-phase-i-study-of-hrs-3005-in-b-cell-malignancies-100635756","NCT07556822","Phase I Study of HRS-3005 in B-cell Malignancies","An Open-Label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-3005 in Patients With B-cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n3. Life expectancy ≥12 weeks;\n4. Histologically or cytologically confirmed relapsed\u002Frefractory B-cell malignancies;\n5. Measurable disease;\n6. Adequate organ function;\n7. Females of childbearing potential must not be pregnant or lactating. Females of childbearing potential and males with partners of childbearing potential must agree to use effective contraception from the time of informed consent until 28 days after the last dose of study treatment;\n8. Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n1. Known central nervous system (CNS) involvement by malignancy;\n2. History of other malignancy within 2 years prior to first dose of study drug, except for the disease under study;\n3. Prior autologous stem cell transplantation or CAR-T therapy within 12 weeks before first dose of study drug;\n4. Prior allogeneic hematopoietic stem cell transplantation;\n5. Positive hepatitis B surface antigen (HBsAg) with detectable HBV-DNA at screening;\n6. Positive hepatitis C antibody with detectable HCV-RNA at screening;\n7. Positive HIV antigen\u002Fantibody test at screening;\n8. Active fungal, bacterial, and\u002For viral infection requiring systemic therapy;\n9. Major surgery or significant trauma within 28 days prior to first dose of study drug;\n10. Severe disease of major organ systems;\n11. Prior anti-tumor treatment-related adverse events not recovered to ≤Grade 1 or stable status;\n12. Incomplete washout period from prior anti-tumor therapy before first dose of study drug;\n13. Use of strong or moderate CYP3A inducers, or strong or moderate CYP3A inhibitors within 14 days prior to first dose of study drug;\n14. Live vaccine administration within 28 days prior to first dose of study drug;\n15. Ongoing alcohol or drug abuse;\n16. Intracranial hemorrhage within 6 months prior to first dose of study drug;\n17. Currently receiving vitamin K antagonists or Factor Xa inhibitors;\n18. History of severe bleeding disorder, such as coagulation factor deficiency or von Willebrand factor (vWF) deficiency;\n19. Inability to swallow oral medication, or presence of severe gastrointestinal disease or prior surgery significantly affecting gastrointestinal function;\n20. Pregnant or lactating females;\n21. Concurrent participation in another interventional clinical study, or less than 1 month between signing informed consent and last dose of previous clinical study.",{"count":80,"type":20},190,[23],"The study is being conducted to evaluate the safety and tolerability of HRS-3005. To explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-3005 in patients with B-cell malignancy.",[26],"2026-06-08",{"date":86,"type":31},"2026-06-10",{"date":88,"type":31},"2026-06-03",{"date":90,"type":20},"2028-12",{"name":92,"class":38},"Jiangsu HengRui Medicine Co., Ltd.",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100564854","phase-1-a-study-to-investigate-safety-and-effectiveness-of-bgb-16673-in-combination-with-other-agents-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100564854","NCT06634589","A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1b\u002F2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies","Key Inclusion Criteria:\n\n* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF\n* Confirmed diagnosis of a R\u002FR B-cell malignancy\n* Protocol-defined measurable disease\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n* Adequate organ function\n* Female 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, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment\n* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax, 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of mosunetuzumab\n* Substudies 1, 3, and 4 Inclusion Criterion:\n\n  * Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL\u002Fmin\n* Substudy 2 Inclusion Criteria:\n\n  * Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression\n  * Adequate renal function as indicated by eGFR of ≥ 30 mL\u002Fmin\n\nKey Exclusion Criteria:\n\n* Treatment-naive B-cell malignancies\n* Unable to comply with the requirements of the protocol\n* Active leptomeningeal disease or uncontrolled, untreated brain metastasis\n* Any malignancy ≤ 2 years before first dose of study treatment except for the specific cancer under investigation in this study or any locally recurring cancer that has been treated curatively\n* Autologous stem cell transplant ≤ 3 months prior to screening or chimeric antigen T-cell therapy ≤ 3 months prior to screening\n* Prior invasive fungal infection, except if participant agrees to receive secondary antifungal prophylaxis during the entire treatment period\n* Substudies 1 and 2: Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or who have taken calcineurin inhibitors within 4 weeks prior to consent\n* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, zanubrutinib, mosunetuzumab, or glofitamab\n* Substudy 1 Exclusion Criterion:\n\n  * Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor (with exception for participants who relapsed ≥ 24 months after completion of a full course of a prior Bcl-2 inhibitor containing regimen)\n* Substudy 2 Exclusion Criterion:\n\n  * Participants who discontinued prior zanubrutinib treatment due to intolerance\n* Substudies 3 and 4 Exclusion Criteria:\n\n  * Prior exposure to a CD20 x CD3 T-cell engager antibody treatment\n  * All participants with a prior allogeneic stem cell transplant\n  * Participants with known contraindications to azole antifungal agents, including hypersensitivity reactions\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":101,"type":20},80,[23,51],"The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R\u002FR) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.",[26,105,106,107],"Relapsed Cancer","Refractory Cancer","B-cell Lymphoma",[109,110,111,112,113,114,115,116,117,118],"R\u002FR B-Cell Malignancies","relapsed or refractory B-Cell Malignancies","B-Cell malignancy","BGB-16673","sonrotoclax","zanubrutinib","B-cell lymphoma","Bruton Tyrosine Kinase (BTK)","Mosunetuzumab","Glofitamab","2026-06-01",{"date":88,"type":31},{"date":122,"type":31},"2024-11-27",{"date":124,"type":20},"2029-12-02",{"name":70,"class":38},50,{"id":128,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":24,"conditions":131,"keywords":4,"overallStatus":132,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":139,"locationsCount":39},"100637547",{"count":19,"type":20},[23],[26],"NOT_YET_RECRUITING","2026-05-07",{"date":135,"type":31},"2026-05-13",{"date":137,"type":20},"2026-06",{"date":35,"type":20},{"name":37,"class":38},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100461905","phase-1-treatment-of-chinese-participants-with-b-cell-malignancies-with-bgb-16673-a-bruton-tyrosine-kinase-targeted-protein-degrader-100461905","NCT05294731","Treatment of Chinese Participants With B-Cell Malignancies With BGB-16673, a Bruton Tyrosine Kinase-Targeted Protein-Degrader","A Phase 1\u002F2, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies","Key Inclusion Criteria\n\n1. Provision of signed and dated written informed consent prior to any study\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2\n3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria\n4. Phase 1: Confirmed diagnosis of R\u002FR Marginal Zone Lymphoma (MZL), Follicular Lymphoma (grade 1-3a), Waldenström Macroglobulinemia (WM), non-germinal center B-cell (non-GCB) diffuse large B-cell lymphoma (DLBCL), Richter's transformation to DLBCL, MCL, or CLL\u002FSLL\n5. Phase 2: Confirmed diagnosis of MCL, or CLL\u002FSLL\n6. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug\n\nKey Exclusion Criteria\n\n1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer\n2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment\n3. Receiving treatment with a strong CYP3A inhibitor or inducer ≤ 14 days before the first dose of BGB-16673, or proton-pump inhibitors ≤ 5 days before the first dose of BGB-16673.\n4. Current or history of central nervous involvement\n5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":148,"type":20},146,[23,51],"This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts",[26,56,60,152,57,54,55,153,154],"Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma","DLBCL Unclassifiable","Richter's Transformation",[26,156,157,158,154,159,160,161,112],"MZL","FL","DLBCL","CDAC","BTK","degrader","2026-04-14",{"date":164,"type":31},"2026-04-17",{"date":166,"type":31},"2022-05-06",{"date":168,"type":20},"2029-01-31",{"name":170,"class":38},"BeiGene",29,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100485537","phase-1-as-1763-in-patients-with-previously-treated-cllsll-or-non-hodgkin-lymphoma-100485537","NCT05602363","AS-1763 in Patients With Previously Treated CLL\u002FSLL or Non-Hodgkin Lymphoma","A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma or Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Provided written informed consent\n* Histologically confirmed B-cell malignancy, including CLL\u002FSLL, WM, MCL, MZL, or FL\n* Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion\n* Failed or are intolerant to ≥2 prior lines of systemic therapy\n* ECOG Performance Status 0 to 2\n* Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹\u002FL, platelet count ≥50 × 10⁹\u002FL, hemoglobin ≥8 g\u002FdL) not requiring transfusion support or growth factors\n* Adequate hepatic function\n* Adequate renal function\n* Ability to swallow tablets and comply with study requirements for the duration of study participation\n* Male and female patients of reproductive potential: Willing to observe conventional and effective birth control methods\n* Male patients: agree not to donate sperm during and for 6 months after the study\n* Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication\n\nExclusion Criteria:\n\n* Transformed disease (eg, Richter's transformation) prior to or during Screening\n* Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib\n* Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study\n* Requiring therapeutic anticoagulation with warfarin\n* Current treatment with certain strong CYP3A4 inhibitors or inducers\n* Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib\n* Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors\n* Refractory to transfusion support\n* Major surgery within 4 weeks before planned start of docirbrutinib\n* Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment\n* Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia\n* History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days\n* Active second malignancy unless in remission with life expectancy \\>2 years\n* Known central nervous system (CNS) involvement by systemic lymphoma\n* Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts\n* Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) \\>470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF \\>470 msec on all 3 ECGs, during Screening\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Positive for HIV. For patients with unknown HIV status, HIV testing will be performed at Screening\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of docirbrutinib\n* Pregnant or lactating.\n* Known hypersensitivity to any component or excipient of docirbrutinib\n* Prior treatment with docirbrutinib\n* Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)\n* Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi",{"count":180,"type":20},120,[23],"This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL\u002FSLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.",[26,58,59,184,60,54,55,56],"Waldenstrom Macroglobulinemia","2025-12-09",{"date":187,"type":31},"2025-12-10",{"date":189,"type":31},"2023-08-01",{"date":191,"type":20},"2027-09",{"name":193,"class":38},"Carna Biosciences, Inc.",13,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100488717","phase-1-a-safety-and-efficacy-study-evaluating-ctx112-in-subjects-with-relapsed-or-refractory-b-cell-malignancies-100488717","NCT05643742","A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies","A Phase 1\u002F2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies","Key Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Refractory or relapsed B cell malignancy.\n3. Eastern Cooperative Oncology Group performance status 0 or 1.\n4. Adequate renal, liver, cardiac and pulmonary organ function.\n5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion.\n\nKey Exclusion Criteria:\n\n1. Prior allogeneic hematopoietic stem cell transplant (HSCT).\n2. Active or history of central nervous system (CNS) involvement by malignancy.\n3. History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.\n5. Active HIV, hepatitis B virus or hepatitis C virus infection.\n6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).\n7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.\n8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and\u002For other immunosuppressive therapy.\n9. Women who are pregnant or breastfeeding.",{"count":180,"type":20},[23,51],"This is an open-label, multicenter, Phase 1\u002F2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.",[107,56,26,206,55,60,54,207],"Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Large B-cell Lymphoma",[209,210,211,212],"CAR T","Non-Hodgkin Lymphoma (NHL)","Lymphoma","Allogeneic","2025-11-13",{"date":215,"type":31},"2025-11-14",{"date":217,"type":31},"2023-03-10",{"date":219,"type":20},"2030-02",{"name":221,"class":38},"CRISPR Therapeutics AG",7,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":39},"100557016","early-phase-1-anti-cd19-car-t-cells-in-subjects-with-relapsedrefractory-b-cell-malignancies-100557016","NCT06532630","Anti-CD19-CAR-T Cells in Subjects With Relapsed\u002FRefractory B Cell Malignancies","An Exploratory Clinical Study Evaluating the Safety and Efficacy of Anti-CD19-CAR-T Cell Therapy in Subjects With Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria:\n\nSubjects must meet all of the following criteria for inclusion in the study:\n\n1. Patient able to provide written informed consent; parent or guardian of minor patient able to provide written informed consent; ability and willingness to adhere to the study visit schedule and all protocol requirements.\n2. 14 - 70 years old.\n3. Relapsed\u002Frefractory disease after standard treatment (including allogeneic\u002Fautologous hematopoietic stem cell transplantation) and not eligible for other treatment options such as a second hematopoietic stem cell transplant.\n\n   A. Relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:\n   * Primary refractory disease.\n   * Relapsed within 12 months after first remission.\n   * Relapsed or refractory after two or more lines of systemic therapy.\n   * Relapsed or refractory post allogeneic SCT. i. more than 100 days from the transplantation at the time of enrollment. ii. not receiving immunosuppressive drugs for 4 weeks prior to enrollment (≤5 mg prednisone or equivalent is allowed).\n\n   B. Ph+ B-cell ALL are eligible if they are intolerant or ineligible for tyrosine kinase inhibitor (TKI) therapy or have relapse\u002Frefractory disease after at least two different TKI treatments.\n\n   C. Relapsed\u002Frefractory B-cell non-Hodgkin lymphoma (NHL) is defined as one of the following:\n   1. No response to first-line therapy (primary refractory disease, excluding subjects intolerant to first-line therapy):\n\n      * PD is the best response after first-line therapy.\n      * Best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R-CHOP) is stable disease (SD), with rapid progression in 6 months.\n   2. No response to second or subsequent lines of therapy:\n\n      * PD is the best response to last regimen.\n      * Best response after at least 2 cycles of the last-line therapy is SD, with rapid progression in 6 months.\n   3. Refractory post-autologous stem cell transplant (ASCT):\n\n      * Disease progression or relapse within 12 months (relapse must be biopsy-proven).\n      * If salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy\n      * Relapsed or refractory after two or more lines of systemic therapy.\n4. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening\n5. Relapsed\u002Frefractory NHL as one of the following subtypes:\n\n   A. DLBCL-NOS B. Primary mediastinal large B-cell lymphoma (PMBCL) C. Transformed follicular lymphoma (TFL) following prior chemotherapy for follicular lymphoma and subsequent transformation to DLBCL with refractory disease.\n\n   D. Mantle cell lymphoma E. High-grade B-cell lymphoma F. CLL\u002FSLL\n6. ECOG performance status ≤2.\n7. Life expectancy ≥ 12 weeks.\n8. Adequate venous access (for apheresis) and no other contraindications for blood cell separation.\n9. Subjects must meet the following laboratory criteria at screening, and they should not have received any growth factors within the 7 days prior to the hematologic assessment:\n\n   A. Absolute neutrophil count ≥1.0×10\\^9\u002FL. For subjects with ALL, specific criteria will be determined by the investigator.\n\n   B. Hemoglobin ≥60 g\u002FL (without RBC transfusion within 14 days). C. Platelets ≥50×10\\^9\u002FL. For subjects with ALL, specific criteria will be determined by the investigator.\n\n   D. Absolute lymphocyte count (ALC) ≥0.5×10\\^9\u002FL. If the total lymphocyte count is insufficient with a high proportion of T cells, the investigator may discuss with the sponsor.\n\n   E. Total bilirubin \\\u003C1.5×ULN; if liver involved, total bilirubin \\\u003C3.0×ULN is allowed.\n\n   F. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; if liver involved, ALT\u002FAST ≤5×ULN is allowed.\n\n   G. Creatinine \\\u003C1.5×ULN and estimated creatinine clearance ≥60 mL\u002Fmin.\n10. Cardiac ejection fraction (EF) ≥45% with no clinically significant findings on electrocardiogram.\n11. Baseline oxygen saturation \\>92% on room air.\n12. Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential).\n\nExclusion Criteria:\n\nIf patients meet any of the following conditions, they cannot participate in this trial:\n\n1. Central nervous system (CNS) involvement in ALL and clinically significant neurological changes (CNS-2 and CNS-3):\n\n   1. CNS-3, defined as detectable tumor cells in cerebrospinal fluid (CSF) with ≥ 5 white blood cells (WBCs) \u002Fmm3.\n   2. CNS-2, defined as detectable tumor cells in CSF with \\\u003C5 WBCs \u002Fmm3. Note: Subjects with CNS-1 (no detectable tumor cells in CSF) or CNS-2 without evidence of clinically significant neurological changes are eligible for this study.\n2. CNS lymphoma confirmed by MRI; active CNS DLBL unless CNS involvement has been effectively treated (i.e., asymptomatic) and a local treatment interval of \\> 4 weeks prior to enrollment.\n3. Active CNS diseases such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disorders, or any autoimmune diseases involving the central nervous system.\n4. Any malignancies other than CD19+ malignancies.\n5. Clinically significant heart disease or arrhythmias not controlled by medication.\n6. Ongoing or suspected fungal, bacterial, viral, or other infections that are uncontrolled or require intravenous antibiotic therapy; simple urinary tract infections and simple bacterial pharyngitis are allowed.\n7. Hepatitis B (positive for hepatitis B surface antigen and hepatitis B DNA \\>1000 copies\u002FmL) and hepatitis C (positive for hepatitis C antibodies); syphilis, human immunodeficiency virus (HIV) infection.\n8. Presence of any indwelling or drainage catheter (e.g., percutaneous nephrostomy, indwelling Foley catheter, biliary drainage catheter, pleural\u002Fperitoneal\u002Fpericardial drainage catheter); the use of dedicated central venous access devices such as Port-A-Cath® or Hickman® catheters is allowed.\n9. Prior use of the following:\n\n   1. CD19-targeted therapy.\n   2. Chlorambucil or bendamustine within 3 months before enrollment, or PEG-asparaginase within 3 weeks before enrollment.\n   3. live vaccines within 4 weeks before enrollment.\n   4. Donor lymphocyte infusions (DLI) within 4 weeks before enrollment.\n   5. Medications for graft-versus-host disease (GVHD) treatment within 4 weeks before enrollment, such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, or siltuximab, or use of immunosuppressive antibodies (anti-CD20, anti-tumor necrosis factor, anti-interleukin 6, or anti-interleukin 6 receptor) within 4 weeks before enrollment.\n   6. Immunostimulatory or immunosuppressive therapy within 4 weeks before enrollment, including interferon-α, interferon-β, IL-2, lenalidomide, efalizumab, alemtuzumab, tocilizumab, cyclosporine, or thalidomide.\n   7. Anti-PD-1\u002Fanti-PD-L1 therapy within 4 weeks before enrollment.\n   8. Systemic cytotoxic chemotherapy within 14 days before enrollment, including daily or weekly low-dose maintenance chemotherapy (e.g., cyclophosphamide, ifosfamide, bendamustine, chlorambucil, melphalan, or vincristine).\n   9. Long-acting growth factors (e.g., pegfilgrastim) within 14 days before apheresis or short-acting growth factors within 5 days before apheresis or mobilization agents (e.g., filgrastim\u002Fpegfilgrastim, plerixafor) within 5 days before apheresis.\n   10. Radiation therapy within 14 days before enrollment.\n   11. Pharmacological doses of corticosteroids (\\>5 mg\u002Fday prednisone or equivalent) or other immunosuppressive drugs within 7 days before enrollment.\n   12. Venetoclax (BCL-2 inhibitor) within 4 days before apheresis.\n   13. Short-acting targeted therapy (e.g., tyrosine kinase inhibitors) within 72 hours before apheresis.\n   14. Idelalisib (oral PI3Kδ inhibitor) within 2 days before apheresis.\n   15. Lenalidomide within 1 day before enrollment.\n10. ≥ Grade 2 graft-versus-host disease (GVHD) per the CIBMTR grading system or requiring systemic corticosteroid treatment exceeding physiological doses.\n11. A history of autoimmune diseases in the past 2 years, such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, leading to end-organ damage or requiring systemic immunosuppression or disease-modifying agents.\n12. A history of heart attack, cardiac catheterization or stent implantation, unstable angina, or other clinically significant heart diseases within 12 months before enrollment.\n13. A history of genetic syndrome with bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Schwachman-Diamond syndrome, etc.\n14. Symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment. Subjects need to be on prophylactic anticoagulation.\n15. A history of or currently having other malignant tumors (excluding skin basal cell carcinoma, breast\u002Fcervical carcinoma in situ, and other malignant tumors that have not been treated in the past five years but are effectively controlled).\n16. Use of other investigational medicinal products within 30 days before screening.\n17. Pregnant, planning to become pregnant, or breastfeeding in reproductive-aged women. Women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered to be of reproductive potential.\n18. Male and female subjects unwilling to practice contraception from the time of agreeing to treatment until 12 months after completion of conditioning chemotherapy or CAR-T infusion.\n19. Any past medical history that may interfere with the safety of the study treatment or the evaluation of efficacy.\n20. Based on the investigator's judgment, subjects are unlikely to complete all the study visits or procedures required by the protocol.\n21. Previous use of any CAR-T cell product or other gene-modified T cell therapy.","14 Years","70 Years",{"count":5,"type":20},[234],"EARLY_PHASE1","This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed\u002Frefractory (r\u002Fr) B-cell malignancies.\n\nThis study plans to enroll patients with relapsed\u002Frefractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.",[237],"B-Cell Malignancy","2025-02-25",{"date":240,"type":31},"2025-02-28",{"date":242,"type":31},"2023-08-24",{"date":244,"type":20},"2026-09-01",{"name":246,"class":38},"Shanghai First Song Biotechnology Co., LTD"]