[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617307":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":28,"studyPopulation":28,"armGroups":36,"interventions":43,"overallOfficials":28,"centralContacts":49,"locations":55,"responsibleParty":72,"collaborators":76,"id":80,"slug":28,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":28,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":101,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Affiliated Hospital of Jiangsu University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Toxicity and adverse-event grading after RN1701 treatment","all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0","up to 12 months after infusion",{"measure":14,"description":15,"timeFrame":12},"CRS grading after RN1701 treatment","Cytokine Release Syndrome (CRS) will be graded using the Lee DW et al. CRS grading scale.\n\nGrade 1: Fever, mild symptoms, manageable with supportive care Grade 2: Moderate symptoms (eg, hypotension, hypoxia), requires intervention (eg, intravenous fluids, antipyretics) Grade 3: Severe symptoms (eg, multiorgan involvement), requires corticosteroids and tocilizumab Grade 4: Life-threatening, requires intensive care unit (ICU) care and urgent interventions",[17,21,23,26],{"measure":18,"description":19,"timeFrame":20},"Overall response rate (ORR = CR + PR) of patients receive RN1701 treatment","according to the Lugano criteria and CSCO guidelines","1, 3, 6, and 12 months after infusion",{"measure":22,"description":19,"timeFrame":20},"Disease control rate (DCR = CR + PR + SD) of patients receive RN1701 treatment",{"measure":24,"description":25,"timeFrame":20},"Assessment includes contrast-enhanced CT of head\u002Fneck, chest, abdomen, and pelvis, plus whole-body PET-CT","Tumor measurements and evaluations must be performed with the same technique used at baseline",{"measure":27,"description":28,"timeFrame":29},"CAR copies and cell count of CAR-T in blood after RN1701 treatment",null,"Days 0, 1, 3, 5, 7, 9, 11, 14, 21, 28 and month 2, 3, 6, 9, 12 after infusion",{"allocation":31,"interventionModel":32,"interventionModelDescription":28,"primaryPurpose":33,"observationalModel":28,"timePerspective":28,"maskingInfo":34},"NA","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":28,"whoMasked":28},"NONE",[37],{"label":38,"type":39,"description":40,"interventionNames":41},"Relapsed\u002Frefractory B-cell lymphoma","EXPERIMENTAL","Relapsed\u002Frefractory B-cell lymphoma patients to be treated with RN1701 cells.",[42],"Biological: RN1701 injection",[44],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":28},"BIOLOGICAL","RN1701 injection","RN1701 injection is a bispecific CD19\u002FCD20-targeted allogeneic CAR-T. A single infusion of CAR-T cells will be administered intravenously",[38],[50],{"name":51,"role":52,"phone":53,"phoneExt":28,"email":54},"Xiaoming Fei, PhD","CONTACT","086-1381512462752","feixiaomingujs@aliyun.com",[56],{"facility":5,"status":28,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Zhenjiang","Jiangsu","212001","China","CN",{"type":63,"coordinates":64},"Point",[65,66],119.45508,32.21086,{"lat":66,"lon":65},[69,70],{"name":51,"role":52,"phone":53,"phoneExt":28,"email":54},{"name":51,"role":71,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","YANRU WANG","Clinical Professor",[77],{"name":78,"class":79},"Allorunning Therapeutics","INDUSTRY","100617307",false,"NCT07316920","A Clinical Study of of 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\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.","ALL","18 Years","75 Years",{"count":90,"type":91},19,"ESTIMATED","INTERVENTIONAL",[94],"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.",[97],"Relapsed\u002FRefractory B-cell Lymphoma",[99,100],"Relapsed\u002Frefractory","B-cell lymphoma","NOT_YET_RECRUITING","2026-01-02",{"date":104,"type":105},"2026-01-06","ACTUAL",{"date":107,"type":91},"2025-12-22",{"date":109,"type":91},"2027-12-31",{"name":74,"class":6},1]