Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:31 AM
Study NCT ID:
NCT07316920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of of RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-02', 'studyFirstSubmitDate': '2025-12-09', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity and adverse-event grading after RN1701 treatment', 'timeFrame': 'up to 12 months after infusion', 'description': 'all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0'}, {'measure': 'CRS grading after RN1701 treatment', 'timeFrame': 'up to 12 months after infusion', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR = CR + PR) of patients receive RN1701 treatment', 'timeFrame': '1, 3, 6, and 12 months after infusion', 'description': 'according to the Lugano criteria and CSCO guidelines'}, {'measure': 'Disease control rate (DCR = CR + PR + SD) of patients receive RN1701 treatment', 'timeFrame': '1, 3, 6, and 12 months after infusion', 'description': 'according to the Lugano criteria and CSCO guidelines'}, {'measure': 'Assessment includes contrast-enhanced CT of head/neck, chest, abdomen, and pelvis, plus whole-body PET-CT', 'timeFrame': '1, 3, 6, and 12 months after infusion', 'description': 'Tumor measurements and evaluations must be performed with the same technique used at baseline'}, {'measure': 'CAR copies and cell count of CAR-T in blood after RN1701 treatment', 'timeFrame': 'Days 0, 1, 3, 5, 7, 9, 11, 14, 21, 28 and month 2, 3, 6, 9, 12 after infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed/refractory', 'B-cell lymphoma'], 'conditions': ['Relapsed/Refractory B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19/CD20-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/refractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and/or CD20-positive cells in patients with relapsed/refractory B-cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/or 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/unable 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/progression ≤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/relapse criteria.\n\n • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible/unable 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/unable 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/dL (no transfusion within 7 days).\n * Platelets ≥50×10⁹/L (no transfusion within 7 days).\n * ANC ≥1.0×10⁹/L (growth-factor support allowed if none within 7 days of test).\n * AST/ALT ≤3×ULN (≤5×ULN if liver involvement).\n * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (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 \\<1.5×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/fludarabine.\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/or 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 \\>1/3 of thoracic diameter;\n * Obstructive/compressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.\n 8. Active CNS involvement (symptomatic or positive CSF/imaging); 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/US, 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) \\<45% by echo or MUGA within 4 weeks before lymphodepletion.\n 13. Resting oxygen saturation \\<92%.\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."}, 'identificationModule': {'nctId': 'NCT07316920', 'briefTitle': 'A Clinical Study of of RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiangsu University'}, 'officialTitle': 'An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas', 'orgStudyIdInfo': {'id': 'RN1701JB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relapsed/refractory B-cell lymphoma', 'description': 'Relapsed/refractory B-cell lymphoma patients to be treated with RN1701 cells.', 'interventionNames': ['Biological: RN1701 injection']}], 'interventions': [{'name': 'RN1701 injection', 'type': 'BIOLOGICAL', 'description': 'RN1701 injection is a bispecific CD19/CD20-targeted allogeneic CAR-T. A single infusion of CAR-T cells will be administered intravenously', 'armGroupLabels': ['Relapsed/refractory B-cell lymphoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '212001', 'city': 'Zhenjiang', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Xiaoming Fei, PhD', 'role': 'CONTACT', 'email': 'feixiaomingujs@aliyun.com', 'phone': '086-1381512462752'}, {'name': 'Xiaoming Fei, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}], 'centralContacts': [{'name': 'Xiaoming Fei, PhD', 'role': 'CONTACT', 'email': 'feixiaomingujs@aliyun.com', 'phone': '086-1381512462752'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'YANRU WANG', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allorunning Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'YANRU WANG', 'investigatorAffiliation': 'Affiliated Hospital of Jiangsu University'}}}}