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Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials - PubMed

18 hours ago
  • #Therapeutic strategies
  • #Clinical trials
  • #Cutaneous T-cell lymphoma
  • The review covers clinical trials in cutaneous T-cell lymphoma (CTCL) from 2015 to 2025, focusing on 134 interventional trials after exclusions.
  • Trials include antibody and biologic therapies, epigenetic modifiers, signaling pathway inhibitors, immunotherapy, cellular therapies, and skin-directed treatments.
  • Notable approvals include denileukin diftitox-cxdl in 2024 for relapsed/refractory CTCL and breakthrough designation for lacutamab in 2025 for Sézary syndrome.
  • Lacutamab showed a 43% overall response rate with a median duration of 25.6 months in Sézary syndrome.
  • CAR-T therapy, specifically CTX130, achieved a 46% overall response rate in heavily pretreated patients, overcoming T-cell fratricide issues.
  • Combination strategies, such as HDAC inhibitors with PI3K inhibitors, achieved 50-60% response rates in refractory cases.
  • For early-stage disease, HyBryte photodynamic therapy demonstrated efficacy in the Phase 3 FLASH trial.
  • The RESMAIN trial, despite meeting its primary endpoint, failed regulatory approval due to quality-of-life issues from gastrointestinal toxicity.
  • Future developments should prioritize patient-reported outcomes, biomarker validation, and combination therapies with non-overlapping toxicities.