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CS1-Targeted CAR-T Cells for Relapsed/Refractory Multiple Myeloma

Study acronym: GZLTCST0001
StatusActive, Not Recruiting
PhasePhase 1
Started2023-07-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-19
notable
Sponsor changed: Qi Junyuan → Institute of Hematology & Blood Diseases Hospital, China+46 characters
WasQi Junyuan
NowInstitute of Hematology & Blood Diseases Hospital, China
This investigator-initiated, exploratory clinical trial is designed to evaluate the feasibility, safety, and preliminary antitumor activity of autologous CS1-targeted chimeric antigen receptor T (CAR-T) cells in adults with relapsed or refractory multiple myeloma (MM). Multiple myeloma is a hematologic malignancy characterized by the clonal proliferation of plasma cells. Despite advances in treatment, patients with relapsed or refractory disease often have limited therapeutic options after multiple lines of therapy. CS1, also known as signaling lymphocytic activation molecule family member 7 (SLAMF7; CD319), is highly expressed on myeloma cells throughout the course of disease and has been investigated as a therapeutic target. The clinical activity of the anti-SLAMF7 monoclonal antibody elotuzumab supports the rationale for targeting this antigen. CS1-targeted CAR-T cell therapy is being investigated as a potential treatment option for patients with relapsed or refractory multiple myeloma. This is an open-label, single-center, non-randomized, Phase I dose-escalation study evaluating autologous CS1-targeted CAR-T cells. The primary objectives are to evaluate the feasibility and safety of autologous CS1-targeted CAR-T cell therapy and to assess its preliminary antitumor activity. Eligible participants are adults with relapsed or refractory multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) criteria who have received multiple prior lines of therapy, have measurable disease, and meet protocol-defined organ function requirements.
Trial Details
NCT Number NCT07809594
Lead Sponsor Institute of Hematology & Blood Diseases Hospital, China
Conditions Relapsed/Refractory Multiple Myeloma (RRMM), Plasma Cell Myeloma
Enrollment 10 participants
Start Date 2023-07-05
Primary Completion 2025-07-21 (estimated)
Study Completion 2027-08-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-18