[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"follicular-lymphoma-grade-3a\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:follicular-lymphoma-grade-3a":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,76,99],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100634893","phase-2-clinical-study-of-xnw5004-tablets-in-the-treatment-of-relapsed-and-refractory-follicular-lymphoma-100634893",false,"NCT07545603","Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma","Phase II Study of XNW5004 in the Treatment of Patients With Relapsed or Refractory Follicular Lymphoma (EZH2 Wild-type)","Inclusion Criteria:\n\n1. Age ≥ 18 years; no gender restriction.\n2. Histologically confirmed follicular lymphoma (FL) grade 1-3a (classic FL per WHO 2022 classification) with wild-type EZH2, as assessed at the study site.\n3. Relapsed or refractory disease following at least 3 prior lines of systemic therapy, including at least one line with adequate treatment using a commercially available anti-CD20 monoclonal antibody and at least one line with adequate treatment using a novel agent (including but not limited to PI3K inhibitors, CD3×CD20 bispecific antibodies, BTK inhibitors, etc.):\n\n   Adequate anti-CD20 mAb treatment: at least 4 cycles of continuous therapy or disease progression during treatment; subjects not meeting this criterion may be included only with a valid justification (e.g., intolerance).\n\n   Adequate novel agent treatment: failure to achieve response, disease progression during treatment, or treatment discontinuation due to intolerance (intolerance defined as meeting treatment discontinuation criteria per the package insert).\n\n   Relapsed disease: relapse ≥6 months after achieving response to any line of therapy.\n\n   Refractory disease, defined by any of the following:\n\n   Response duration \\\u003C6 months and ineligible for or unwilling to undergo autologous hematopoietic stem cell transplantation (auto-HSCT); Failure to achieve response after at least 4 cycles of treatment; Best response or treatment discontinuation due to progressive disease, regardless of number of cycles; Relapse after auto-HSCT.\n4. Prior radiotherapy is permitted; radiotherapy alone is not considered a systemic therapy.\n5. Availability of sufficient biological samples for EZH2 mutation testing.\n6. At least one measurable lesion: nodal lesion with longest diameter \\>1.5 cm; extranodal lesion with longest diameter \\>1.0 cm and FDG-PET positive.\n7. Life expectancy ≥12 weeks.\n8. ECOG performance status 0 or 1.\n\n   Adequate organ function:\n\n   Hematologic function:\n9. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL (≥1.0×10⁹\u002FL if bone marrow involvement); no G-CSF within 1 week or long-acting G-CSF within 2 weeks before screening CBC.\n\n   Platelets ≥90×10⁹\u002FL (≥75×10⁹\u002FL if bone marrow involvement); no platelet transfusion or TPO receptor agonist within 1 week before screening CBC.\n\n   Hemoglobin ≥90 g\u002FL (≥80 g\u002FL if bone marrow involvement); no red blood cell transfusion or EPO within 1 week before screening CBC.\n\n   Hepatic function:\n\n   Total bilirubin ≤1.5×ULN (≤3×ULN for Gilbert's syndrome); ALT and AST ≤2.5×ULN; ≤5×ULN with liver involvement; ALP ≤5×ULN with liver and\u002For bone involvement.\n\n   Renal function:\n\n   Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin by Cockcroft-Gault equation.\n\n   Left ventricular ejection fraction (LVEF) ≥50%. INR ≤1.5×ULN, or PT and APTT ≤1.5×ULN.\n10. Women of childbearing potential must have a negative serum pregnancy test at study entry and agree to use highly effective contraception from study start until at least 6 months after last dose of study drug.\n\n    Non-childbearing potential is defined as:\n\n    Amenorrhea ≥12 months with confirmation of menopausal status by hormonal testing and specialist assessment; OR Bilateral oophorectomy, hysterectomy, or tubal ligation ≥6 weeks before screening.\n\n    Male subjects must agree to use effective contraception and refrain from sperm donation from study start until at least 6 months after last dose of study drug.\n11. Signed and dated written informed consent prior to any study-specific procedures, and ability to comply with study visits and protocol-required assessments.\n\nExclusion Criteria:\n\n1. Follicular lymphoma grade 3b, mixed histology, potential for transformation, or documented histologic transformation.\n2. Prior treatment with an EZH2 inhibitor or EZH1\u002F2 inhibitor (including but not limited to tazemetostat).\n3. Known hypersensitivity to the investigational product, its active ingredients, or excipients.\n4. Received chemotherapy, immunotherapy, radiotherapy, targeted therapy, antitumor traditional Chinese medicine, or other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; received CAR-T therapy within 12 weeks prior to the first dose; underwent autologous hematopoietic stem cell transplantation (auto-HSCT) within 3 months prior to the first dose.\n5. Received investigational antitemporal agents not approved in China within 28 days prior to initiation of study treatment.\n6. Underwent major surgery within 4 weeks prior to initiation of study treatment, or planning major surgery during the study period (excluding procedures such as puncture or lymph node biopsy).\n7. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n8. Disease requiring systemic therapy with corticosteroids (\\> 10 mg prednisone daily or equivalent) or other immunosuppressive agents within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement therapy with ≤ 10 mg prednisone daily or equivalent are permitted in the absence of active autoimmune disease.\n9. Received moderate or strong CYP3A4 inhibitors\u002Finducers within 14 days prior to the first dose (see Appendix 4 for details).\n10. Received live or live-attenuated viral vaccines within 28 days prior to dosing. Inactivated vaccines are permitted.\n11. History of psychoactive substance abuse or drug addiction (except for insomnia with stable, long-term therapy as assessed by the investigator).\n12. Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 per NCI-CTCAE version 5.0, except for toxicities deemed by the investigator not to affect patient safety evaluation (e.g., alopecia).\n13. History of another malignancy within 3 years prior to enrollment that does not meet criteria for clinical cure, except for adequately treated and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n14. Previous or current central nervous system involvement by lymphoma.\n15. Previous or current testicular or breast involvement by lymphoma.\n16. Previous or current hemophagocytic lymphohistiocytosis.\n17. Previous or current primary or secondary hematologic disorders other than the primary malignant neoplasm that may affect bone marrow function, including immune thrombocytopenia, autoimmune hemolytic anemia, and aplastic anemia.\n18. Previous or current acute myeloid leukemia (AML).\n19. Previous or current T-lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia (T-ALL).\n20. History of any myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal laboratory findings associated with MDS or myeloproliferative neoplasms (MPN).\n21. Previous or current central nervous system disorders including, but not limited to: epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, etc. (excluding stroke with adequate treatment and stable disease for ≥12 months before first dose, or asymptomatic lacunar infarction not requiring treatment).\n22. Impaired cardiac function or clinically significant cardiac disease, including any of the following:\n\n    Acute myocardial infarction within 12 months prior to first dose; Unstable angina; Congestive heart failure (NYHA Class III or IV, see Appendix 5); Uncontrolled serious arrhythmia, hypertension ≥ 150\u002F100 mmHg; Prolonged QTcF interval (\\> 450 ms in males, \\> 470 ms in females) calculated by Fredericia's formula (see Appendix 6); History of other major cardiovascular disease (e.g., valve replacement, coronary artery bypass grafting, etc.).\n23. Tumor invasion of adjacent vital organs, gastrointestinal tract, or blood vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of hemorrhage, or risk of esophagotracheal fistula, esophagopleural fistula, gastrointestinal perforation, etc.\n24. Clinically symptomatic pleural effusion, ascites, or pericardial effusion poorly controlled despite repeated treatment.\n25. Unexplained fever with body temperature \\> 38.0 °C (including tumor fever); body temperature must be within normal range for 2 weeks prior to first dose.\n26. Systemic active severe infection: at least 2 weeks washout after completion of antifungal therapy (intravenous or oral), at least 1 week washout after completion of other intravenous antimicrobial therapy, and oral antimicrobial therapy must be discontinued prior to first dose.\n27. History of tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without adequate anti-tuberculosis treatment.\n28. Positive HIV test or positive syphilis (Anti-TP) test (patients with negative non-treponemal test and syphilis deemed cured by the investigator are not excluded).\n29. Positive HBsAg with HBV-DNA above the lower limit of detection, or anti-HBc positive with HBV-DNA above the lower limit of detection; positive HCV antibody with HCV-RNA above the lower limit of detection.\n30. Inability to swallow, or active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or history of gastrectomy, gastric banding, or other conditions affecting drug absorption. Proton pump inhibitor-treated gastroesophageal reflux is permitted if no potential drug-drug interaction exists.\n31. Known bleeding disorders such as von Willebrand disease or hemophilia.\n32. Female patients who are pregnant or breastfeeding.\n33. Patients who may be unable to complete the study for any other reason, or whom the investigator deems ineligible for enrollment.","ALL","18 Years",{"count":19,"type":20},65,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a single-arm, open-label, multicenter Phase II clinical study designed to enroll 65 subjects with relapsed or refractory follicular lymphoma (EZH2 wild-type).\n\nThe study procedures include a pre-screening phase, screening phase, treatment phase, and follow-up phase.Eligible subjects will enter the treatment phase and receive 1200 mg of XNW5004 tablets twice daily, with a 10-14-hour interval between doses. Each treatment cycle consists of 28 consecutive days of dosing, and pharmacokinetic (PK) blood samples will be collected at the designated time points.Safety assessments and quality-of-life (QoL) assessments will be performed in accordance with the study follow-up schedule.Tumor assessments will be conducted every 8 weeks (every 2 cycles) for the first 48 weeks after the first dose (Cycles 1 to 12), and every 12 weeks (every 3 cycles) thereafter (from Cycle 13 onward).Subjects who discontinue treatment must complete an end-of-treatment visit and safety follow-up.\n\nFor long-term follow-up:Subjects who terminate treatment for reasons other than disease progression and do not initiate new antineoplastic therapy will continue tumor assessments per the original schedule until disease progression, initiation of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.For all patients (excluding those who withdraw informed consent, are lost to follow-up, or die), survival follow-up will be performed every 12 weeks (±7 days) starting from the date of the last tumor assessment, until withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.",[26,27,28,29],"Follicular Lymphoma, Grade 1","Follicular Lymphoma, Grade 2","Follicular Lymphoma, Grade 3","Follicular Lymphoma Grade 3A",[31,32],"Follicular Lymphoma","Phrase II","RECRUITING","2026-04-21",{"date":36,"type":37},"2026-04-22","ACTUAL",{"date":39,"type":37},"2026-02-14",{"date":41,"type":20},"2028-12-31",{"name":43,"class":44},"Evopoint Biosciences Inc.","INDUSTRY",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100468248","long-term-follow-up-study-of-lentiviral-based-gene-edited-immune-cell-therapy-100468248","NCT05377307","Long-term Follow-up Study of Lentiviral-based Gene-edited Immune Cell Therapy","Long-term Follow-up Study to Evaluate the Safety and Efficacy in Patients Who Have Ever Received Lentiviral-based Gene-edited Immune Cell Therapy","Inclusion Criteria:\n\n1. Patients must have ever received Pell's lentiviral-based gene-edited immune cell as monotherapy or as combination therapy in clinical trials.\n2. The last lentiviral-based gene-edited immune cell infusion within 15 years.\n3. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for this study.",{"count":54,"type":20},49,"OBSERVATIONAL","According to health authorities guidances (FDA 2006, EMA(European Medicines Agency) 2009) for gene therapy clinical trials, observing subjects for delayed adverse events for 15 years is recommended. This purpose of this long-term follow-up study is to evaluate the safety and efficacy in patients who have ever received lentiviral-based gene-edited immune cells which are manufactured by Pell Bio-Med Technology Co. Ltd.",[58,59,60,29,61],"Diffuse Large B Cell Lymphoma","Large B-cell Lymphoma","Primary Mediastinal Large B Cell Lymphoma","Follicular Lymphoma Grade 3B",[63,64,65],"DLBCL(Diffuse Large B Cell Lymphoma)","PMLBCL(Primary Mediastinal Large B Cell Lymphoma)","FL(Follicular Lymphoma)","2025-05-07",{"date":68,"type":37},"2025-05-13",{"date":70,"type":37},"2022-12-29",{"date":72,"type":20},"2037-12",{"name":74,"class":44},"Pell Bio-Med Technology Co., Ltd.",5,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":75},"100464326","phase-1-phase-12-study-of-cd19-chimeric-antigen-receptor-t-cell-cd19-car-t-pl001-for-relapsed-or-refractory-b-cell-lymphoma-100464326","NCT05326243","Phase 1\u002F2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma","A Phase 1\u002F2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma","Inclusion Criteria:\n\nScreening 1:\n\n1. Patient is ≥14 years of age, inclusive, at the time of signing the informed consent.\n2. Histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMLBCL), large B-cell lymphoma transformed from follicular lymphoma (FL), or grade 3a or 3b FL.\n3. On-site documentation of CD19 on the dominant population of cancer cells.\n4. Disease status should meet any one of the below:\n\n   1. Patients with previous autologous-hematopoietic stem cell transplantation (auto HSCT) have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after transplantation regardless of lines of systemic therapy.\n   2. Patients without previous HSCT have relapsed, progressive, or refractory disease (defined as having not achieved a CR) after at least 2 lines of systemic therapy, including anti-CD20 antibody and anthracycline.\n5. Have no available effective systemic therapy as judged by the Investigator.\n6. At least one measurable non-CNS (central nervous system) lesion based on Lugano classification for lymphoma.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n8. Life expectancy of at least 3 months.\n9. Patient is male or female.\n10. A male patient must agree to use a highly effective contraception as detailed in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating sperm during this period.\n\n    Female Patients:\n11. A female patient is eligible to participate if she is not pregnant (Section 10.4; Appendix 4), not breastfeeding, and at least one of the following conditions applies:\n\n    • Not a woman of childbearing potential (WOCBP) as defined in Section 10.4 (Appendix 4).\n\n    OR\n\n    • A WOCBP who agrees to follow the contraceptive guidance in Section 10.4 (Appendix 4) during the treatment period and for at least 2 years after the dose of PL001 and refrain from donating ova during this period.\n12. Patient\u002Fpatient's parent\u002Flegal guardian is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nScreening 2:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n2. CAR-T is successfully manufactured and ready for use, from cells harvested by non mobilized leukapheresis.\n3. WOCBP who have a negative serum pregnancy test at Screening 2.\n\nExclusion Criteria:\n\nScreening 1:\n\n1. Chronic lymphocytic leukemia with Richter's transformation.\n2. Primary CNS lymphoma. (Non-primary CNS lymphoma with CNS involvement is eligible).\n3. Primary intra-ocular lymphoma.\n4. Prior CD19 targeted therapy, such as CAR-T, Bi-specific T-cell engagers (BiTE), or monoclonal antibody.\n5. History of cancers (includes myelodysplastic syndrome) other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free without active treatment for at least 3 years.\n6. History of allogeneic HSCT.\n7. History of autologous HSCT within 3 months prior to consent.\n8. Received any investigational product within 4 weeks prior to consent.\n9. Systemic anticancer therapy within 3 weeks prior to apheresis.\n10. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent, within 2 weeks prior to leukapheresis.\n\n    Exception examples:\n    * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n    * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n    * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n11. Use of long-acting and short-acting myeloid growth factor within 2 weeks, 5 days prior to leukapheresis, respectively.\n12. Received anti-thymocyte globulin within 4 weeks prior to consent.\n13. Intrathecal chemotherapy within 1 week prior to leukapheresis.\n14. Inadequate major organ functions at Screening, which were defined as any of below:\n\n    1. absolute neutrophil count (ANC) \\\u003C500\u002FµL\n    2. Absolute lymphocyte count (ALC) \\\u003C300\u002FµL, excluding leukemic cells.\n    3. Hemoglobin (Hb) \\\u003C8.0 g\u002FdL\n    4. Platelet count \\\u003C75,000\u002FµL without transfusion support within 3 days\n    5. e. Baseline O2 saturation \\\u003C92% by pulse oximetry at room air\n    6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n    7. Aspartate aminotransferase (AST) \\>5 × upper limit of normal (ULN) and alanine aminotransferase (ALT) \\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n    8. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n    9. Significant cardiac disease including but not limited to: left ventricular ejection fraction (LVEF) \\\u003C50%, QTc(the corrected QT interval) \\> 480 msec based on Fredericia's formula, clinically significant arrhythmias, history of myocardial infarction or unstable angina within 3 months prior to consent.\n15. Active hepatitis B virus (HBV) infection defined as detectable HBV DNA (Patients with positive anti-hepatitis B core antibody \\[HBcAb\\] must consent to regular monitoring of HBV DNA, and anti-HBV prophylaxis with oral anti-viral agent (such as entecavir) is mandatory until End-of-Study visit \\[Visit 15\\].)\n16. Active hepatitis C virus (HCV) infection defined as positive anti- HCV antibody plus detectable HCV RNA.\n17. Positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV) infection.\n18. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to apheresis).\n\n21\\. Any medical conditions which might compromise the patient's safety from leukapheresis, lymphodepletion chemotherapy, or CAR-T therapy and anticipated AEs, according to the Investigator's evaluation.\n\n22.Patients with insufficient leukapheresis cells.\n\nScreening 2:\n\n1. Inadequate major organ functions at Screening which were defined as any of below:\n\n   1. ANC \\\u003C500\u002FµL\n   2. Hb \\\u003C8.0 g\u002FdL\n   3. Platelet count \\\u003C50,000\u002FµL, without transfusion support within 3 days\n   4. Baseline O2 saturation \\\u003C92% by pulse oximetry on room air\n   5. AST \\>5 × ULN and ALT\\>5 × ULN, or total bilirubin \\>2 × ULN (except for constitutional jaundice)\n   6. Significant CNS diseases such as dementia, major stroke, seizure while under antiepileptic drug\n   7. Serum creatinine \\> 1.5 × ULN and estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m², as calculated by the Cockcroft-Gault formula.\n2. Long-term use of systemic corticosteroids, defined as daily use \\>10 mg of prednisolone or equivalent.\n\n   Exception examples:\n   * Nasal, ophthalmic, inhaled, intra-articular, and topical steroid preparation.\n   * Short term systemic steroid for drug, contrast, or blood transfusion allergic reaction management.\n   * Low dose maintenance steroid therapy for other conditions (e.g., asthma).\n3. Use of long-acting and short-acting myeloid growth factor within 12 days, 2 days prior to lymphodepletion therapy, respectively.\n4. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g. the need for intravenous therapeutic antibiotics, blood culture positive ≤72 hours prior to lymphodepletion).\n5. Any medical condition which might compromise the patient's safety because of lymphodepletion chemotherapy or CAR-T therapy and anticipated AEs, according to the Investigator's opinion.","14 Years",{"count":54,"type":20},[86,23],"PHASE1","This is a multiple center, non-randomized, open-label, phase 1\u002F2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).",[58,60,59,29,61],[90,91,92],"DLBCL","PMLBCL","FL",{"date":68,"type":37},{"date":95,"type":37},"2022-05-31",{"date":97,"type":20},"2027-03-31",{"name":74,"class":44},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100589983","phase-2-obinutuzumab-with-chop-versus-obinutuzumab-with-bendamustine-in-the-treatment-of-newly-diagnosed-follicular-lymphoma-grade-3a-100589983","NCT06961500","Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A","A Multicenter, Phase 2, Randomized Trial of Obinutuzumab With CHOP Versus Obinutuzumab With Bendamustine in the Treatment of Newly Diagnosed Follicular Lymphoma Grade 3A (FL)","PROOF","Inclusion Criteria:\n\n1. Histologically confirmed follicular lymphoma Grades 3A, CD20 positive by immunohistochemistry.\n2. Meets at least one GELF (Groupe d'Etude des Lymphomes Folliculaires) criteria.\n3. No prior systemic treatment for lymphoma.\n4. Presence of measurable lesions.\n5. Age ≥ 18 years, no gender restriction.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n7. Expected survival of \\> 3 months.\n8. Adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. History of allergy to any component of monoclonal antibodies or investigational drugs.\n2. Central nervous system involvement.\n3. History of previous malignant tumors.\n4. History of active bleeding or bleeding tendencies, or requiring anticoagulant medication.\n5. Requirement for potent CYP3A4 inhibitors for treatment.\n6. Active infection, except for tumor-related B symptoms.\n7. Known history of Human Immunodeficiency Virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS).\n8. Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).\n9. Significant organ dysfunction or uncontrolled comorbidities, such as uncontrolled hypertension, decompensated cirrhosis, uncontrolled diabetes, chronic obstructive pulmonary disease, etc.\n10. History of severe heart disease.\n11. Major surgery within 4 weeks prior to enrollment.\n12. Participation in other clinical trials with drug intervention within 4 weeks prior to enrollment.\n13. Pregnant or breastfeeding women, or planning to become pregnant during the study.\n14. Individuals with psychiatric disorders, history of alcohol or drug abuse, or inability to provide informed consent.\n15. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.",{"count":108,"type":20},133,[23],"This is a multicenter, phase 2, randomized trial to evaluate the efficacy and safety of obinutuzumab with CHOP versus obinutuzumab with bendamustine in treatment-naïve follicular lymphoma (Grade 3A) patients.",[29],"NOT_YET_RECRUITING","2025-04-29",{"date":115,"type":37},"2025-05-08",{"date":117,"type":20},"2025-05-01",{"date":119,"type":20},"2030-11-01",{"name":121,"class":122},"Sun Yat-sen University","OTHER"]