[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636273":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":20,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":39,"enrollmentInfo":40,"targetDuration":20,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":20,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":20},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"RN1701 treatment for relapsed\u002Frefractory B-cell lymphoma","EXPERIMENTAL","Patients with relapsed\u002Frefractory B-cell lymphoma will receive a single dose of RN1701 cells.",[13],"Biological: RN1701 injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Lei Fan","CONTACT","025-68306124","fanlei3014@126.com",{"type":28,"investigatorFullName":23,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Attending Physician","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":41,"type":42},10,"ESTIMATED","INTERVENTIONAL",[45],"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.",[48],"Relapsed\u002FRefractory B-cell Lymphoma","NOT_YET_RECRUITING","2026-04-29",{"date":52,"type":53},"2026-05-04","ACTUAL",{"date":55,"type":42},"2026-05-08",{"date":57,"type":42},"2028-06-30",{"name":5,"class":6}]