[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,66,89,107,128,149,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100636273","early-phase-1-rn1701-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphomas-100636273",false,"NCT07563543","RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","Inclusion Criteria:\n\n* 1\\. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.\n* 2\\. Age 18-75 years; either sex.\n* 3\\. ECOG performance status 0-1.\n* 4\\. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and\u002For CD20 positive.\n* 5\\. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \\>1.5 cm, extranodal lesion \\>1.0 cm.\n* 6\\. Prior treatment response must meet one of the following: • Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles. ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse\u002Fprogression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen. v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory\u002Frelapse criteria. • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy. ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen. • Mantle-cell lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles. ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n* 7\\. Estimated life expectancy ≥3 months.\n* 8\\. Screening laboratory values (may be repeated once): • Hemoglobin ≥8.0 g\u002FdL (no transfusion within 7 days). • Platelets ≥50×10⁹\u002FL (no transfusion within 7 days). • ANC ≥1.0×10⁹\u002FL (growth-factor support allowed if none within 7 days of test). • AST\u002FALT ≤3×ULN (≤5×ULN if liver involvement). • Serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault). • Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN). • INR, PT, APTT \\\u003C1.5×ULN.\n* 9\\. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.\n* 10\\. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide\u002Ffludarabine.\n* 11\\. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.\n\nExclusion Criteria:\n\nSubjects with any of the following conditions are ineligible for this trial:\n\n* 1\\. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except: • Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or • Adequately treated non-melanoma skin cancer with no current evidence of disease.\n* 2\\. Prior anti-cancer therapy within the stated windows (before lymphodepletion): • CNS prophylaxis (e.g., intrathecal methotrexate and\u002For cytarabine) within 7 days; • Cytotoxic chemotherapy or radiotherapy within 14 days; • Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer; • Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter; • Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies); • Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.\n* 3\\. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.\n* 4\\. Any allogeneic cellular (including CAR-T) or gene therapy.\n* 5\\. Prior allogeneic haematopoietic stem-cell transplantation.\n* 6\\. Positive donor-specific antibody (DSA).\n* 7\\. At least one of the following high-risk features: • Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²; • Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \\>1\u002F3 of thoracic diameter; • Obstructive\u002Fcompressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.\n* 8\\. Active CNS involvement (symptomatic or positive CSF\u002Fimaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.\n* 9\\. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam\u002FUS, cytopenias, hyperplastic marrow) or ongoing anticoagulation.\n* 10\\. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).\n* 11\\. Severe underlying medical conditions: • Active serious viral, bacterial or uncontrolled systemic fungal infection; • Active systemic autoimmune disease requiring therapy.\n* 12\\. Significant cardiac disease: • NYHA class III or IV congestive heart failure; • Myocardial infarction or CABG within 6 months before enrolment; • Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related; • Severe non-ischaemic cardiomyopathy; • Left ventricular ejection fraction (LVEF) \\\u003C45% by echo or MUGA within 4 weeks before lymphodepletion.\n* 13\\. Resting oxygen saturation \\\u003C92%.\n* 14\\. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.\n* 15\\. Live-attenuated vaccine within 4 weeks before screening.\n* 16\\. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).\n* 17\\. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.\n* 18\\. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.\n* 19\\. Lactating women.\n* 20\\. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.","ALL","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19\u002FCD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and\u002For CD20-positive cells in patients with relapsed\u002Frefractory B-cell lymphoma.",[27],"Relapsed\u002FRefractory B-cell Lymphoma","NOT_YET_RECRUITING","2026-04-29",{"date":31,"type":32},"2026-05-04","ACTUAL",{"date":34,"type":21},"2026-05-08",{"date":36,"type":21},"2028-06-30",{"name":38,"class":39},"The First Affiliated Hospital with Nanjing Medical University","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100634972","early-phase-1-nanobody-based-cd19cd20-tandem-dual-car-t-cell-therapy-of-relapsedrefractory-b-cell-lymphoma-100634972","NCT07546630","Nanobody-Based CD19\u002FCD20 Tandem Dual CAR-T-cell Therapy of Relapsed\u002FRefractory B-Cell Lymphoma","Clinical Study on the Safety and Efficacy of Nanobody-Based CD19\u002FCD20 Tandem Dual CAR-T-cell Therapy for Relapsed\u002FRefractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures\n2. Patients with relapsed\u002Frefractory B-cell lymphoma confirmed by cytology or histology according to the WHO 2022 Classification:\n\n   * Lymphoma cells confirmed to express CD19 and\u002For CD20 antigen by immunophenotyping or histopathological immunohistochemistry\n   * B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL\u002FSLL, FL, MZL, LPL, HCL)\n   * Relapsed\u002Frefractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy\n3. Aged 18-75 years (inclusive), male or female\n4. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2\n5. Estimated overall survival of more than 3 months from the date of signing the informed consent form\n6. Hemoglobin (HGB) ≥ 70 g\u002FL (transfusion permitted)\n7. Adequate hepatic, renal and cardiopulmonary function meeting the following criteria:\n\n   * Creatinine ≤ 1.5 × ULN;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * Blood oxygen saturation \\> 90%;\n   * Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN\n8. The subject agrees to use contraceptive measures from the date of signing the informed consent form until 1 year after CAR-T cell infusion\n\nExclusion Criteria:\n\n* Severe cardiac insufficiency with left ventricular ejection fraction \\\u003C 50%\n* History of severe pulmonary function-impairing diseases\n* Concomitant other advanced malignant neoplasms\n* Concomitant severe infection that cannot be effectively controlled\n* Concomitant severe autoimmune diseases or congenital immunodeficiency disorders\n* Active hepatitis (hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] or hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test result above the lower limit of detection)\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection\n* History of severe allergy to biological products (including antibiotics)\n* Patients with allogeneic hematopoietic stem cell transplantation who still have acute graft-versus-host disease (GVHD) after one month of discontinuation of immunosuppressive agents",{"count":48,"type":21},20,[24],"This is a single arm study to evaluate the safety and efficacy of Nanobody-Based CD19\u002FCD20 Tandem Dual CAR-T-cell therapy for Relapsed\u002FRefractory B-Cell Lymphoma",[52],"Relapsed\u002FRefractory B-Cell Lymphoma",[52,54,55,56,57],"Nanobody","CD19","CD20","CAR-T","2026-04-23",{"date":29,"type":32},{"date":61,"type":21},"2026-04-30",{"date":63,"type":21},"2029-05-01",{"name":65,"class":39},"Affiliated Hospital to Academy of Military Medical Sciences",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100634438","phase-1-phase-i-clinical-study-on-the-safety-and-efficacy-of-cy-219-car-t-cell-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphoma-100634438","NCT07539688","Phase I Clinical Study on the Safety and Efficacy of CY-219 CAR-T Cell Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphoma","Inclusion Criteria:\n\n* 1\\. The participant has given consent and signed the informed consent form, and is willing and able to comply with the planned visits, research treatments, laboratory tests, and other trial procedures;\n* 2\\. Clinically diagnosed as a patient with relapsed\u002Frefractory B-cell lymphoma, and confirmed by pathological and histological examination as CD19 and\u002For CD22 B-cell lymphoma, including: diffuse large B-cell lymphoma, or transformed large B-cell lymphoma from indolent B-cell lymphoma (excluding Richter transformation, THRLBCL, BL). And meets the following criteria (meets any one of the first three items and the fourth): i. Recurrence ≥6 months after achieving remission with first-line full treatment, or ≥12 months after achieving remission following stem cell transplantation; ii. Progression during first-line treatment combined with high-risk factors (double-expressor lymphoma, double-hit lymphoma, TP53 gene mutation or deletion, IPI score ≥3); iii. Disease relapse after ≥2 lines of treatment or failure to achieve remission; iv. The participant has received the following treatment regimens after being diagnosed with LBCL:\n\n  * Anti-CD20 monoclonal antibody;\n  * Combination chemotherapy containing anthracyclines.\n* 3\\. Age 18 or older, both men and women are eligible;\n* 4\\. Study participants with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n* 5\\. Expected survival of more than 3 months from the date of signing the informed consent;\n* 6\\. HGB ≥ 60 g\u002FL (transfusion allowed); LYM ≥ 0.3×10\\^9\u002FL;\n* 7\\. Liver and kidney function and cardiopulmonary function must meet the following requirements:\n\n  1. Creatinine ≤ 1.5 × ULN;\n  2. Left ventricular ejection fraction ≥ 50%;\n  3. Blood oxygen saturation \\> 90%;\n  4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;\n* 8\\. Participants intending to become pregnant must agree to use contraception before enrollment in the study and for one year after CAR-T cell infusion; if a participant becomes pregnant or suspects pregnancy, they should immediately inform the investigator.\n\nExclusion Criteria:\n\n* 1\\. Severe heart failure or left ventricular ejection fraction \\\u003C50%;\n* 2\\. History of severe pulmonary function impairment;\n* 3\\. Concurrent other malignant tumors in the progressive stage;\n* 4\\. Concurrent severe infection that cannot be effectively controlled;\n* 5\\. Concurrent severe autoimmune disease or congenital immunodeficiency;\n* 6\\. History of CAR-T cell immunotherapy;\n* 7\\. Active hepatitis (hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] or hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test results above the detection limit);\n* 8\\. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection.\n* 9\\. A history of severe allergic reactions to biological products (including antibiotics);\n* 10\\. Allogeneic hematopoietic stem cell transplant patients who still have acute graft-versus-host disease (GvHD) one month after stopping immunosuppressive agents;\n* 11\\. Women who are pregnant, breastfeeding, or planning to become pregnant within 12 months;\n* 12\\. Patients with other serious physical or mental illnesses or abnormal laboratory test results that may increase the risk of participating in the study, or interfere with study results, or who are deemed by the investigators to be unsuitable for participation in this study.",{"count":73,"type":21},18,[75],"PHASE1","This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed\u002Frefractory B-cell lymphoma, aimed at evaluating the safety and efficacy of CAR-T cell infusion.",[27,78,79],"Diffuse Large B-cell Lymphoma","Inert B-cell Lymphoma Transformed Into Large B-cell Lymphoma (Excluding Richter Transformation, THRLBCL, and BL)","2026-04-13",{"date":82,"type":32},"2026-04-20",{"date":84,"type":21},"2026-05-01",{"date":86,"type":21},"2029-12-01",{"name":88,"class":39},"Institute of Hematology & Blood Diseases Hospital, China",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":25,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100631898","phase-1-rn1701-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphomas-100631898","NCT07506668","Inclusion Criteria:\n\n1. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.\n2. Age 18-75 years; either sex.\n3. ECOG performance status 0-1.\n4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and\u002For CD20 positive.\n5. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \\>1.5 cm, extranodal lesion \\>1.0 cm.\n6. Prior treatment response must meet one of the following:\n\n   • Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse\u002Fprogression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory\u002Frelapse criteria.\n\n   • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   • Mantle-cell lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n7. Estimated life expectancy ≥3 months.\n8. Screening laboratory values (may be repeated once):\n\n   * Hemoglobin ≥8.0 g\u002FdL (no transfusion within 7 days).\n   * Platelets ≥50×10⁹\u002FL (no transfusion within 7 days).\n   * ANC ≥1.0×10⁹\u002FL (growth-factor support allowed if none within 7 days of test).\n   * AST\u002FALT ≤3×ULN (≤5×ULN if liver involvement).\n   * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault).\n   * Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN).\n   * INR, PT, APTT \\\u003C1.5×ULN.\n9. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.\n10. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide\u002Ffludarabine.\n11. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions are ineligible for this trial:\n\n  1. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except:\n\n     * Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or\n     * Adequately treated non-melanoma skin cancer with no current evidence of disease.\n  2. Prior anti-cancer therapy within the stated windows (before lymphodepletion):\n\n     * CNS prophylaxis (e.g., intrathecal methotrexate and\u002For cytarabine) within 7 days;\n     * Cytotoxic chemotherapy or radiotherapy within 14 days;\n     * Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer;\n     * Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter;\n     * Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies);\n     * Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.\n  3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.\n  4. Any allogeneic cellular (including CAR-T) or gene therapy.\n  5. Prior allogeneic haematopoietic stem-cell transplantation.\n  6. Positive donor-specific antibody (DSA).\n  7. At least one of the following high-risk features:\n\n     * Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²;\n     * Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \\>1\u002F3 of thoracic diameter;\n     * Obstructive\u002Fcompressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.\n  8. Active CNS involvement (symptomatic or positive CSF\u002Fimaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.\n  9. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam\u002FUS, cytopenias, hyperplastic marrow) or ongoing anticoagulation.\n  10. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).\n  11. Severe underlying medical conditions:\n\n      * Active serious viral, bacterial or uncontrolled systemic fungal infection;\n      * Active systemic autoimmune disease requiring therapy.\n  12. Significant cardiac disease:\n\n      * NYHA class III or IV congestive heart failure;\n      * Myocardial infarction or CABG within 6 months before enrolment;\n      * Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related;\n      * Severe non-ischaemic cardiomyopathy;\n      * Left ventricular ejection fraction (LVEF) \\\u003C45% by echo or MUGA within 4 weeks before lymphodepletion.\n  13. Resting oxygen saturation \\\u003C92%.\n  14. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.\n  15. Live-attenuated vaccine within 4 weeks before screening.\n  16. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).\n  17. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.\n  18. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.\n  19. Lactating women.\n  20. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.",{"count":20,"type":21},[75,96],"PHASE2",[27],"2026-03-28",{"date":100,"type":32},"2026-04-02",{"date":102,"type":21},"2026-03-23",{"date":104,"type":21},"2028-05-30",{"name":106,"class":39},"Affiliated Hospital of Nantong University",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100632047","phase-1-efficacy-and-safety-of-cd19cd20-cartruc-t-in-relapsedrefractory-b-cell-lymphoma-100632047","NCT07508605","Efficacy and Safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma","CAR\u002FTRuC-T","Inclusion Criteria\n\nSubjects must meet all of the following criteria to be enrolled:\n\n1. Aged 18 to 75 years, regardless of sex;\n2. Histologically confirmed relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) classification;\n3. ECOG performance status of 0-2;\n4. Expected survival of at least 3 months;\n5. CD20 expression on tumor cells confirmed by flow cytometry and\u002For immunohistochemistry;\n6. Patients who are resistant\u002Frefractory to CD19 CAR-T cell therapy or have low CD19 expression;\n7. No severe cardiac, pulmonary, hepatic, or renal disease;\n8. Able to understand and willing to sign the informed consent form for this study;\n9. No contraindications to peripheral blood mononuclear cell collection\u002Fapheresis;\n10. At least one measurable and evaluable lesion according to RECIST 1.1;\n11. Must have previously received standard first-line and second-line therapy;\n12. No antibody-based therapy within 2 weeks prior to cell therapy. Exclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded:\n\n1. History of allergy to any component of the cell product;\n2. Abnormal complete blood count meeting any of the following: WBC ≤1 × 10⁹\u002FL, ANC ≤0.5 × 10⁹\u002FL, ALC ≤0.5 × 10⁹\u002FL, or PLT ≤25 × 10⁹\u002FL;\n3. Laboratory abnormalities including, but not limited to, any of the following: total serum bilirubin ≥1.5 mg\u002FdL; ALT or AST \\>2.5 times the upper limit of normal; serum creatinine ≥2.0 mg\u002FdL;\n4. New York Heart Association (NYHA) Class III or IV heart failure, or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography;\n5. Abnormal pulmonary function, with oxygen saturation \\\u003C92% on room air;\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;\n7. Grade 3 hypertension with poor blood pressure control despite medication;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease;\n9. Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;\n10. Presence of uncontrolled active infection;\n11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;\n12. Receipt of a live vaccine within 4 weeks prior to enrollment;\n13. Positive for HIV, HBV, HCV, or TPPA\u002FRPR, or HBV carrier status;\n14. History of alcohol abuse, drug abuse, or psychiatric illness;\n15. Participation in any other clinical study within 3 months prior to enrollment in this study;\n16. Female subjects meeting any of the following conditions:\n\n    1. currently pregnant or breastfeeding;\n    2. planning to become pregnant during the study period; or\n    3. of childbearing potential and unwilling or unable to use effective contraception;\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.",{"count":48,"type":21},[75,96],"1. Study Title:\n\n   A Study on the Efficacy and safety of CD19\u002FCD20 CAR\u002FTRuC-T in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   Primary Objective: To evaluate the safety of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 CAR\u002FTRuC-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n\n   Exploratory Objective: To assess in vivo expansion and persistence of infused CD19\u002FCD20 CAR\u002FTRuC-T cells.\n3. Participant Intervention:\n\nParticipants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20 CAR\u002FTRuC-T cell infusion. The CAR\u002FTRuC-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[27],"RECRUITING","2026-03-27",{"date":100,"type":32},{"date":122,"type":32},"2025-01-01",{"date":124,"type":21},"2027-12-30",{"name":126,"class":39},"Shenzhen University General Hospital",1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":14,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":25,"conditions":136,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":127},"100617307","phase-1-a-clinical-study-of-of-rn1701-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphomas-100617307","NCT07316920","A Clinical Study of of RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas",{"count":134,"type":21},19,[75],[27],[138,139],"Relapsed\u002Frefractory","B-cell lymphoma","2026-01-02",{"date":142,"type":32},"2026-01-06",{"date":144,"type":21},"2025-12-22",{"date":146,"type":21},"2027-12-31",{"name":148,"class":39},"YANRU WANG",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":57,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":156,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":127},"100600416","phase-1-efficacy-and-safety-of-cd19cd20-carp40-t-in-b-cell-lymphoma-100600416","NCT07097207","Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma","Study on the Efficacy and Safety of Autocrine p40 Chimeric Antigen Receptor T Cells Targeting CD19 and CD20 (CD19CD20-CAR.p40-T) in Refractory B-Cell Lymphoma","Inclusion Criteria:\n\n1. Aged between 15 and 75 years old, regardless of gender;\n2. Diagnosed with relapsed\u002Frefractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;\n4. Expected survival time of ≥ 3 months;\n5. Confirmation of CD20 expression in tumor cells by flow cytometry\u002Fimmunohistochemistry;\n6. Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;\n7. No severe heart, lung, liver, or kidney diseases;\n8. Capable of understanding and willing to sign the informed consent form for this trial;\n9. No contraindications to peripheral blood apheresis for the subject;\n10. Having clearly measurable and evaluable lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard;\n11. The subject must have received standard first- and second-line treatment regimens;\n12. Not having received antibody-based drug treatment within 2 weeks before cell therapy.\n\nExclusion Criteria:\n\n1. History of allergy to any component in the cell product;\n2. The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹\u002FL, absolute neutrophil count (ANC) ≤ 0.5×10⁹\u002FL, absolute lymphocyte count (ALC) ≤ 0.5×10⁹\u002FL, platelet count (PLT) ≤ 25×10⁹\u002FL;\n3. The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg\u002Fdl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg\u002Fdl;\n4. Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) \\\u003C 50% as detected by echocardiography;\n5. Abnormal lung function with oxygen saturation \\\u003C 92% under room air;\n6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment;\n7. Grade 3 hypertension with poorly controlled blood pressure despite drug treatment;\n8. History of craniocerebral trauma, disturbance of consciousness, epilepsy, severe cerebral ischemia or intracerebral hemorrhagic diseases;\n9. Patients with autoimmune diseases, immunodeficiency, or other conditions requiring immunosuppressive agent treatment;\n10. Presence of uncontrolled active infection;\n11. Previous use of any CAR-T cell product or other genetically modified T cell therapies;\n12. Vaccination with live vaccines within 4 weeks before enrollment;\n13. Subjects positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Treponema pallidum particle agglutination assay (TPPA)\u002Frapid plasma reagin (RPR), as well as HBV carriers;\n14. History of alcohol abuse, drug abuse, or mental illness in the subject;\n15. The subject participated in any other clinical study within 3 months before joining this clinical study;\n16. Female subjects with any of the following conditions: a) Currently pregnant or breastfeeding; or b) Having a pregnancy plan during the trial period; or c) Being fertile but unable to take effective contraceptive measures;\n17. Other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in this study.",{"count":48,"type":21},[75,96],"1. Study Title:\n\n   A Study on the Efficacy and Safety of Autocrine p40 CD19\u002FCD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19\u002FCD20-CAR.p40-T) in Relapsed\u002FRefractory B-Cell Lymphoma\n2. Study Objectives:\n\n   * Primary Objective: To evaluate the safety of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n   * Secondary Objective: To evaluate the efficacy of CD19\u002FCD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed\u002Frefractory B-cell lymphoma.\n3. Participant Intervention:\n\n   * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19\u002FCD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.",[27],"2025-07-24",{"date":162,"type":32},"2025-07-31",{"date":164,"type":32},"2023-10-01",{"date":166,"type":21},"2026-09-30",{"name":126,"class":39},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":118,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":195},"100550318","phase-1-study-evaluating-ism8207-in-participants-with-advanced-solid-tumors-and-relapsedrefractory-b-cell-lymphoma-100550318","NCT06445517","Study Evaluating ISM8207 in Participants With Advanced Solid Tumors and Relapsed\u002FRefractory B-Cell Lymphoma","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ISM8207 Monotherapy in Patients With Advanced Solid Tumors or Relapsed\u002FRefractory B-Lymphoid Malignancies","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Advanced solid tumors: Histologically confirmed advanced or metastatic solid tumors who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.\n\n   B-cell lymphoma: Histologically confirmed B-cell lymphoma who had received at least one prior line of standard therapy and were relapsed after or refractory to the standard therapy.\n3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria or Lugano 2014.\n4. ECOG PS (Eastern Cooperative Oncology Group Performance Status)≤1.\n5. Life expectancy of ≥12 weeks as judged by the investigator.\n6. Adequate organ function as determined by medical assessment.\n7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n8. Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception during the treatment period and for 90 days after the last dose of ISM8207.\n\nExclusion Criteria:\n\n1. Prior treated with other QPCTL, CD47 or SIRPα inhibitors.\n2. Burkitt lymphoma\u002Fleukemia, plasma cell myeloma, plasmablastic lymphoma.\n3. Participation in other therapeutic clinical studies within 28 days or 5 half- lives (whichever is shorter) prior to first dose of study treatment.\n4. Anti-tumor therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, or other anti-tumor therapy) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.\n5. Previous allogeneic stem cell transplantation or autologous stem cell. transplantation within 3 months prior to first receiving study treatment.\n6. Unresolved toxicity of Grade \\>1 attributed to any prior therapies (excluding alopecia).\n7. Received antitumor steroid therapy within 7 days prior to the first study treatment administration.\n8. A serious illness or medical condition(s)",{"count":176,"type":21},60,[75],"The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed\u002Frefractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed\u002Frefractory B-cell lymphoma",[180,27],"Advanced Solid Tumors",[182,183,184],"Advanced solid tumors","Relapsed\u002Frefractory B-cell lymphoma","Lymphoma, B-cell","2024-06-05",{"date":187,"type":32},"2024-06-07",{"date":189,"type":32},"2024-04-25",{"date":191,"type":21},"2027-02-28",{"name":193,"class":194},"InSilico Medicine Hong Kong Limited","INDUSTRY",2]