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

ConditionsMultiple Myeloma in RelapseMultiple Myeloma Refractory
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHebei Senlang Biotechnology Inc., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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%;

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous BCMA-targeting CAR T cells

    Biological/Vaccine

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

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Experimental: S103 BCMA CAR-T Autologous BCMA-targeting CAR T cells, intravenous iExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Safety

Time frame
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

Time frame
2 years

Secondary outcomes

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.

Time frame
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.

Time frame
2 years
3

Objective response rate after S103 infusion

Efficacy

Time frame
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.

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Senlang Biotechnology Inc., Ltd.

Lead sponsor

Peking University People's Hospital

Collaborator

Institute of Hematology & Blood Diseases Hospital, China

Collaborator

Source ClinicalTrials.gov

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