RecruitingPhase 1NCT06185751

Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma

Phase 1 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma


Sponsor

Washington University School of Medicine

Enrollment

25 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. BCMA-targeting CAR-T cells show impressive response rates; however, their median duration of response is disappointing. The investigators propose that CS1(SLAMF7)-targeting CAR-T cells will fill a gap in the MM armamentarium. CS1 is an attractive target in MM because it is expressed in most patients. Elotuzumab (Empliciti®), an approved anti-CS1 antibody, has proven the clinical efficacy of this target. CAR-T cells are an ideal modality to target CS1, given that two approved treatments, ide-cel (idecabtagene vicleucel, AbecmaTM) and cilta-cel (ciltacabtagene autoleucel, Carvykti™), have proven the potential for cellular immunotherapy in MM. The investigators are testing the safety and preliminary anti-myeloma efficacy of WS-CART-CS1, a CAR-T cell therapy targeting CS1.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of CAR-T cell therapy (called WS-CART-CS1) that targets a protein called CS1 on cancer cells, in people with multiple myeloma (a blood cancer) who have already tried several other treatments without lasting success. **You may be eligible if...** - You have multiple myeloma that has come back or stopped responding to treatment - You have already received at least 3 prior treatment regimens, including a proteasome inhibitor (like bortezomib), an anti-CD38 drug (like daratumumab), and an anti-BCMA therapy - Your disease is still measurable (detectable through blood or urine tests or bone marrow biopsy) - You are in reasonably good overall health **You may NOT be eligible if...** - You have active brain cancer involvement - You have severe organ problems (heart, liver, or kidney) - You have an active infection or autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALWS-CART-CS1

-Subject will be hospitalized for 7 days

DRUGLymphodepleting chemotherapy

* Cyclophosphamide 500 mg/m\^2 IV on Days -5, -4, and -3 * Fludarabine 30 mg/m\^2 IV on Days -5, -4, and -3


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06185751


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