Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-06 @ 2:14 AM
Study NCT ID:
NCT07421856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2025-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of SENL103 for Relapsed or Refractory Multiple Myeloma: A Multicenter, Open-Label, Single-Arm Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) after S103 infusion', 'timeFrame': '28 days', 'description': 'Safety'}, {'measure': 'Incidence, severity, and relationship of DLTs, AEs and SAEs.', 'timeFrame': '2 years', 'description': 'Safety. To evaluate the possible adverse events occurred within 2 years after S103 infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic data parameters.Analysis using CAR DNA copy number measured by qPCR; the highest concentration of S103 cells expanded in peripheral blood after administration', 'timeFrame': '2 years', 'description': 'PK.To characterize the in vivo expansion kinetics of S103.'}, {'measure': 'Pharmacodynamics data parameters. Proportion of BCMA-positive cells and Cytokine release.', 'timeFrame': '2 years', 'description': 'PD.To assess the ability of S103 to eliminate BCMA-positive B cells.'}, {'measure': 'Objective response rate after S103 infusion', 'timeFrame': '3 months', 'description': 'Efficacy'}, {'measure': 'Best overall response after S103 infusion', 'timeFrame': '2 years', 'description': 'Effectiveness. Best overall response means the proportion of patients with the best efficacy after S103 cell therapy.'}, {'measure': 'Duration of Response after S103 infusion', 'timeFrame': '2 years', 'description': 'Effectiveness. The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first'}, {'measure': 'Progression-Free Survival after S103 infusion', 'timeFrame': '2 years', 'description': 'Effectiveness. The time from the initiation of S103 infusion to the first documented disease progression or death from any cause, whichever occurs first.'}, {'measure': 'Overall survival after S103 infusion', 'timeFrame': '2 years', 'description': 'Effectiveness. Overall survival means the time from infusion of S103 cells to death of subjects from any cause.'}, {'measure': 'Time to Response after S103 infusion', 'timeFrame': '2 years', 'description': 'Effectiveness. The time from the initiation of S103 infusion to the first documented objective response.'}, {'measure': 'MRD-negative ORR at Month 3 post-infusion by flow cytometry', 'timeFrame': '3 months', 'description': 'Effectiveness'}, {'measure': 'MRD-negative ORR at Day-28 post-infusion by flow cytometry.', 'timeFrame': '28 days', 'description': 'Effectiveness'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['S103', 'Multiple Myeloma', 'CAR-T'], 'conditions': ['Multiple Myeloma in Relapse', 'Multiple Myeloma Refractory']}, 'descriptionModule': {'briefSummary': 'To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma', 'detailedDescription': 'This study is a Phase I/II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S103 in patients with Relapsed or Refractory Multiple Myeloma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 1.The subject must understand and voluntarily sign the informed consent form (ICF) before any study-related assessments/procedures.; 2.Male or female subjects aged 18 to 70 years (inclusive) at the time of signing the informed consent form; 3.Life expectancy of no less than 12 weeks; 4.ECOG performance status of 0 to 1; 5.Diagnosis of relapsed/refractory multiple myeloma (RRMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, with at least 3 prior lines of therapy, including regimens based on proteasome inhibitors, immunomodulatory agents, and CD38 monoclonal antibodies; disease progression documented by radiographic evidence within 12 months following the most recent anti-myeloma therapy.; 6.The subject must have measurable multiple myeloma disease, which must meet at least one of the following criteria:\n\n 1. Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;\n 2. Serum M-protein levels: IgG type M-protein ≥10 g/L; or IgA, IgD, IgE, IgM type M-protein ≥5 g/L;\n 3. 24-hour urine M-protein level ≥200 mg;\n 4. For light chain multiple myeloma without measurable serum or urine lesions: serum free light chain (sFLC) ≥100 mg/L and abnormal serum κ/λ free light chain ratio;\n\nExclusion Criteria:\n\n* 1.Subjects with asymptomatic (smoldering) multiple myeloma; 2.Subjects with multiple myeloma with extramedullary lesions (excluding isolated extramedullary lesions with a maximum cross-sectional diameter ≤3 cm)； 3.Subjects with active plasma cell leukemia (defined as peripheral blood plasma cells \\>5%), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloidosis at screening; 4.Subjects with clinically significant cardiovascular disease, including any of the following:\n\n 1. QTc interval \\>470 ms (QTc interval corrected using the Fridericia formula);\n 2. New York Heart Association (NYHA) Class II or higher heart failure;\n 3. Unstable angina or acute myocardial infarction within 6 months prior to signing the informed consent form (ICF);\n 4. Left ventricular ejection fraction (LVEF) \\<50%;\n 5. Poorly controlled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg); Arrhythmia that is either clinically significant or requires antiarrhythmic therapy (e.g., persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes, or complete left bundle branch block); 5.Subjects who have previously received BCMA-targeted therapies, BCMA CAR-T therapy, or other cellular therapies 6.Subjects who have previously received the following antineoplastic therapies: monoclonal antibody treatment for multiple myeloma within 21 days prior to autologous stem cell collection, cytotoxic chemotherapy or proteasome inhibitors within 14 days prior to autologous stem cell collection, immunomodulatory agents within 7 days prior to autologous stem cell collection, or any other antineoplastic therapies within 14 days or at least 5 half-lives (whichever is longer) prior to autologous stem cell collection; 7.Subjects with interstitial lung disease or interstitial pneumonia at the time of signing the ICF; 8.Subjects with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and psoriasis) or other conditions requiring immunosuppressive therapy (except for low-dose corticosteroids) at screening; 9.Subjects who have received live or inactivated vaccines within 28 days prior to signing the ICF;"}, 'identificationModule': {'nctId': 'NCT07421856', 'briefTitle': 'Phase I/II Study of SENL103 for Relapsed or Refractory Multiple Myeloma: A Multicenter, Open-Label, Single-Arm Trial.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hebei Senlang Biotechnology Inc., Ltd.'}, 'officialTitle': 'A Multicenter, Open-label, Single-Arm Phase I/II Clinical Study to Evaluate the Safety and Efficacy of SENL103 Autologous T Cell Injection (S103) in Subjects With Relapsed or Refractory Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'S103-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous i', 'description': 'Biological: Autologous BCMA-targeting CAR T cells\n\nBiological: BCMA CAR-T;\n\nAdministration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.', 'interventionNames': ['Biological: Autologous BCMA-targeting CAR T cells']}], 'interventions': [{'name': 'Autologous BCMA-targeting CAR T cells', 'type': 'BIOLOGICAL', 'description': 'Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.', 'armGroupLabels': ['Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous i']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin Lu', 'role': 'CONTACT', 'email': 'jinllu@sina.com', 'phone': '13311491805'}], 'overallOfficials': [{'name': 'Jin Lu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Senlang Biotechnology Inc., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}