SL4903 CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
NCT07234721 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-02-10
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.
Conditions
- Relapsed and Refractory Multiple Myeloma (RRMM)
Interventions
- DRUG
-
SL4903 Autologous T-Cell Injection
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(1×10⁶ CAR⁺ cells/kg) cellular therapy.
- DRUG
-
SL4903 Autologous T-Cell Injection
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(2×10⁶ CAR⁺ cells/kg) cellular therapy.
- DRUG
-
SL4903 Autologous T-Cell Injection
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(3×10⁶ CAR⁺ cells/kg) cellular therapy.
Sponsors & Collaborators
-
Hebei Senlang Biotechnology Inc., Ltd.
collaborator INDUSTRY -
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Principal Investigators
-
An · Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences,Tianjin
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-01
- Primary Completion
- 2028-03-20
- Completion
- 2028-10-30
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