SL4903 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
9 participantsStarted 2026-02-01
Plain-language summary
This is a Phase I, single-center, single-arm, open-label clinical study to evaluate the safety, tolerability, and preliminary efficacy of SL4903 autologous T-cell injection (CAR-T cell therapy) in adult patients with relapsed or refractory multiple myeloma (r/r MM) who have failed prior standard therapies.
The study employs a "3+3" dose-escalation design with three planned dose levels (1×10⁶, 2×10⁶, and 3×10⁶ CAR+ cells/kg). Approximately 9 to 18 evaluable subjects will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), and to characterize the safety profile and potential anti-myeloma activity of SL4903.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years; either sex.
✓. Able to understand the study and provide voluntary written informed consent.
✓. Histologically and/or cytologically confirmed multiple myeloma according to IMWG 2016 criteria, meeting the following conditions:
✓. Patients must have received at least one prior line of anti-myeloma therapy, including treatment with proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies, or patients with multiple myeloma refractory to proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies;
✓. Documented evidence of disease progression or failure to achieve complete response (CR) following the last line of therapy, as assessed by the investigator according to IMWG criteria.
✓. Measurable disease at screening, defined as meeting one or more of the following criteria:
✓. ECOG performance status 0-2.
✓. Adequate organ function:
Exclusion criteria
✕. History of severe immediate hypersensitivity to any study drug.
✕. Central nervous system (CNS) disorders such as epilepsy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or neuropathy (resolved cases without residual symptoms may be exempted at the investigator's discretion). Active CNS involvement, prior CNS myelomatous disease, or meningeal/spinal cord involvement signs must be excluded.
What they're measuring
1
Number and incidence rate of adverse events following intravenous infusion of SL4903 cells
Timeframe: one month
Trial details
NCT IDNCT07234721
SponsorInstitute of Hematology & Blood Diseases Hospital, China
✕. Concurrent uncontrolled malignancies other than adequately treated cervical carcinoma in situ, basal-cell or squamous-cell skin carcinoma, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, or thyroid cancer after curative surgery.
✕. Clinically significant cardiovascular disease, e.g., uncontrolled or symptomatic arrhythmia, congestive heart failure, or NYHA class III/IV cardiac disease; myocardial infarction, coronary angioplasty/stenting, unstable angina, or other clinically relevant cardiac disorders within 12 months before enrollment.
✕. Any severe comorbidity or condition judged by the investigator to increase subject risk or interfere with the study, including but not limited to liver cirrhosis or recent major trauma.
✕. Allogeneic hematopoietic stem-cell transplantation within 6 months before screening, or any immunosuppressive therapy for graft-versus-host disease during screening.