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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma in Relapse; Multiple Myeloma Refractory
• Intervention / Treatment: Biological: Autologous BCMA-targeting CAR T cells

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jin Lu; Phone Number: 13311491805; Email: jinllu@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. Bone marrow cytology, bone marrow biopsy tissue, or flow cytometry showing ≥5% clonal plasma cells or immature plasma cells;
  2. Serum M-protein levels: IgG type M-protein ≥10 g/L; or IgA, IgD, IgE, IgM type M-protein ≥5 g/L;
  3. 24-hour urine M-protein level ≥200 mg;
  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;

Exclusion Criteria:

• 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous i; 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; Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic data parameters.Analysis using CAR DNA copy number measured by qPCR; the highest concentration of S103 cells expanded in peripheral blood after administration	PK.To characterize the in vivo expansion kinetics of S103.	2 years
Pharmacodynamics data parameters. Proportion of BCMA-positive cells and Cytokine release.	PD.To assess the ability of S103 to eliminate BCMA-positive B cells.	2 years
Objective response rate after S103 infusion	Efficacy	3 months
Best overall response after S103 infusion	Effectiveness. Best overall response means the proportion of patients with the best efficacy after S103 cell therapy.	2 years
Duration of Response after S103 infusion	Effectiveness. The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first	2 years
Progression-Free Survival after S103 infusion	Effectiveness. The time from the initiation of S103 infusion to the first documented disease progression or death from any cause, whichever occurs first.	2 years
Overall survival after S103 infusion	Effectiveness. Overall survival means the time from infusion of S103 cells to death of subjects from any cause.	2 years
Time to Response after S103 infusion	Effectiveness. The time from the initiation of S103 infusion to the first documented objective response.	2 years
MRD-negative ORR at Month 3 post-infusion by flow cytometry	Effectiveness	3 months
MRD-negative ORR at Day-28 post-infusion by flow cytometry.	Effectiveness	28 days

Collaborators and Investigators

• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborators: Peking University People's Hospital; Institute of Hematology & Blood Diseases Hospital, China
• Investigators: Principal Investigator: Jin Lu, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; CAR-T; S103
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: S103-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No