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Multiple Myeloma in RelapsePhase 1/2NCT07421856

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

A Phase 1/2 study testing Autologous BCMA-targeting CAR T cells in people with Multiple Myeloma in Relapse and Multiple Myeloma Refractory, run by Hebei Senlang Biotechnology Inc., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Autologous BCMA-targeting CAR T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 1 Feb 2030
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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;
  • 24-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;

Who cannot join

  • 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:
  • 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;

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jin Lu contact

13311491805

jinllu@sina.com

About this study

Official title: 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

Read the 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

Being tested
Autologous BCMA-targeting CAR T cells
Keywords
S103, Multiple Myeloma, CAR-T
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous BCMA-targeting CAR T cellsBiological

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

Study groups in NCT07421856
Study groupRoleWhat they receive
Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous iExperimentalBiological: 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.
Receives: Biological: Autologous BCMA-targeting CAR T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Safety

    Measured: 28 days

  2. 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

    Measured: 2 years

Secondary outcomes (10)

  1. 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.

    Measured: 2 years

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

    PD.To assess the ability of S103 to eliminate BCMA-positive B cells.

    Measured: 2 years

  3. Objective response rate after S103 infusion

    Efficacy

    Measured: 3 months

  4. Best overall response after S103 infusion

    Effectiveness. Best overall response means the proportion of patients with the best efficacy after S103 cell therapy.

    Measured: 2 years

  5. 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

    Measured: 2 years

  6. 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.

    Measured: 2 years

  7. Overall survival after S103 infusion

    Effectiveness. Overall survival means the time from infusion of S103 cells to death of subjects from any cause.

    Measured: 2 years

  8. Time to Response after S103 infusion

    Effectiveness. The time from the initiation of S103 infusion to the first documented objective response.

    Measured: 2 years

  9. MRD-negative ORR at Month 3 post-infusion by flow cytometry

    Effectiveness

    Measured: 3 months

  10. MRD-negative ORR at Day-28 post-infusion by flow cytometry.

    Effectiveness

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421856
Sponsor's protocol ID
S103-101
Status last verified
Feb 2026
First submitted
17 Dec 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous BCMA-targeting CAR T cells in people with Multiple Myeloma in Relapse and Multiple Myeloma Refractory, run by Hebei Senlang Biotechnology Inc., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Lu (13311491805, jinllu@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) after S103 infusion (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07421856.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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