Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma
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 re
| Condition(s) | Multiple Myeloma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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, |
| Who can participate | Inclusion Criteria: * Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including proteasome inhibitor (e.g. bortezomib or carfilzomib), anti-CD38 therapy (e.g. daratumumab), and anti-BCMA therapies (e.g. BCMA bispecific antibodies or BCMA CAR-T) * Measurable disease, defined as meeting at least one of the following criteria: * Serum M-protein ≥ 0.5 g/dL * Urine M-protein ≥ 200 mg/24 h * In patients without measurable serum and urine M-protein levels, the difference between involved and uninvolved FLC levels (absolute increase) must be \>10 mg/dL for consideration of defining progression before enrollment * A biopsy-proven plasmacytoma * Bone marrow plasma cells \> 30% of total bone marrow cells * At least 18 years of age. * ECOG performance status ≤ 1 * Adequ |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Washington University School of Medicine |
| Locations | St Louis, Missouri, United States |
| Start date | 2024-08-22 |
| NCT ID | NCT06185751 |
| Official listing | https://clinicaltrials.gov/study/NCT06185751 |