Phase I/II Study of SENL103 for Relapsed or Refractory Multiple Myeloma: A Multicenter, Open-Label, Single-Arm Trial.

NCT07421856 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: S103-101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma Refractory

Keywords

S103; Multiple Myeloma; CAR-T

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) after S103 infusion

  Safety

  28 days

• Incidence, severity, and relationship of DLTs, AEs and SAEs.

  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

  2 years

Secondary Outcomes (10)

• Pharmacokinetic data parameters.Analysis using CAR DNA copy number measured by qPCR; the highest concentration of S103 cells expanded in peripheral blood after administration

  2 years

• Pharmacodynamics data parameters. Proportion of BCMA-positive cells and Cytokine release.

  2 years

• Objective response rate after S103 infusion

  3 months

• Best overall response after S103 infusion

  2 years

• Duration of Response after S103 infusion

  2 years

Study Arms (1)

Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous i

EXPERIMENTAL

Biological: Autologous BCMA-targeting CAR T cells Biological: BCMA CAR-T; Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Biological: Autologous BCMA-targeting CAR T cells

Interventions

Autologous BCMA-targeting CAR T cells BIOLOGICAL

Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous i

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;
• Serum M-protein levels: IgG type M-protein ≥10 g/L; or IgA, IgD, IgE, IgM type M-protein ≥5 g/L;
• hour urine M-protein level ≥200 mg;
• 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;

You may not qualify if:

• 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:
• QTc interval \>470 ms (QTc interval corrected using the Fridericia formula);
• New York Heart Association (NYHA) Class II or higher heart failure;
• Unstable angina or acute myocardial infarction within 6 months prior to signing the informed consent form (ICF);
• Left ventricular ejection fraction (LVEF) \<50%;
• 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;

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Peking University People's Hospital: collaborator
• Institute of Hematology & Blood Diseases Hospital, China: collaborator

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jin Lu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Lu

CONTACT

13311491805; jinllu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share