Sylvant (siltuximab)

Following a protocol amendment to evaluate the efficacy of siltuximab as a first-line treatment of CRS, one patient received siltuximab with full resolution of CRS after two doses without needing additional anti-cytokine-directed therapies...This extended experience demonstrates that CD19.22.BBζ CAR T-cell therapy is safe and clinically active, particularly as a bridge to HSCT. Non-response was confined to patients with non-CNS EMD, highlighting the persistent challenge of effectively targeting EMD and informing the design of future CAR constructs.Trial registration numberNCT03448393.

P2/3, N=340, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2029 --> Oct 2033 | Trial primary completion date: Feb 2029 --> Oct 2033

P2, N=24, Completed, University of Alabama at Birmingham | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> Jan 2026 | Trial primary completion date: Dec 2026 --> Jan 2026

These findings establish CSDE1 as a novel tumor suppressor in EC and elucidate a previously unrecognized post-transcriptional CSDE1-IL-6 regulatory axis. By linking RBP-mediated mRNA stability to oncogenic inflammatory signaling, our study provides critical insights into the molecular drivers of EC progression. Furthermore, we identify the IL-6 signaling pathway as a significant therapeutic vulnerability that could be exploited to treat CSDE1-deficient EC.

P2/3, N=340, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

P2/3, N=340, Not yet recruiting, Merck Sharp & Dohme LLC

P2/3, N=129, Active, not recruiting, Amgen Inc. | Recruiting --> Active, not recruiting

P2, N=14, Recruiting, University of Pennsylvania | Trial primary completion date: Dec 2028 --> Jul 2028

Early intervention with daratumumab may reduce the risk of disease progression and mortality in people with high-risk SMM. The evidence on the risk of adverse events with daratumumab is very uncertain. For immunomodulatory agents, the available evidence is of very low certainty, partly due to conflicting results, so we are unable to draw conclusions about their effects. There is insufficient evidence to support the use of older agents like alkylating agents or cytokine inhibitors. The decision to initiate early treatment in high-risk SMM requires a careful, individualized risk-benefit assessment and shared decision-making.

This approach was associated with only three grade 1-2 infections, indicating a favorable safety profile. These preliminary results support the design of a prospective multicenter study to evaluate the feasibility of home-based BiTE administration, integrating point-of-care testing, a digital health platform, and 24/7 remote monitoring via a dedicated call center, within a comprehensive medico-economic framework.

P2/3, N=129, Recruiting, Amgen Inc.

P2/3, N=295, Recruiting, Amgen Inc.