Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06185751

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

Led by Washington University School of Medicine · Updated on 2026-04-30

25

Participants Needed

1

Research Sites

836 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

P

Paula C. & Rodger O. Riney Blood Cancer Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including proteasome inhibitors, anti-CD38 therapy, and anti-BCMA therapies
  • Measurable disease by at least one of these: serum M-protein  0.5 g/dL, urine M-protein  200 mg/24 h, involved/uninvolved FLC difference >10 mg/dL, biopsy-proven plasmacytoma, or bone marrow plasma cells >30% of total
  • At least 18 years of age
  • ECOG performance status of 0 or 1
  • Adequate kidney, liver, lung, and heart function as defined by creatinine clearance  50 mL/min/1.73 m2 or equivalent, ALT  5 x ULN, total bilirubin  2.0 x ULN (with exceptions), oxygen saturation >91% on room air, and LVEF  45% confirmed within 28 days
  • Agreement to use 2 forms of contraception, including a barrier method, before and for 12 months after treatment if of childbearing potential
  • Ability to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Systemic therapy for multiple myeloma within 14 days before planned leukapheresis
  • History of other cancers except treated non-melanoma skin cancers or cancers treated over 2 years ago with no disease evidence
  • Currently receiving other investigational agents
  • Receipt of any cellular therapy within 8 weeks before conditioning
  • History of allergic reactions to similar compounds as CS1 CAR-T or study agents
  • History of Grade 3 cytokine release syndrome or neurotoxicity with CAR-T therapies
  • Active hepatitis B or C, uncontrolled infections, or HIV infection
  • Active infection or serious medical condition impairing protocol treatment
  • Pregnant or breastfeeding women; negative pregnancy test required within 14 days before entry if applicable

AI-Screening

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

A

Armin Ghobadi, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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