Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma (MCL): Primary Analysis of the MCL Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study
Liso‑cel demonstrated high CR rate and deep, durable responses with low incidence of grade 3 CRS, NE, and infections in patients with heavily pretreated relapsed/refractory MCL.
In the open‑label phase I TRANSCEND NHL 001 trial, 88 adults with relapsed/refractory mantle cell lymphoma (MCL) received the CD19‑directed, 4‑1BB CAR‑T product lisocabtagene maraleucel (liso‑cel). At dose level 2, the primary cohort achieved an overall response rate of 86.5 % and a complete response rate of 74.3 %. Median duration of response was 15.7 months and median progression‑free survival was 15.3 months. Grade ≥3 cytokine release syndrome, neurotoxicity, and infections occurred in 24 %, 31 %, and 15 % of patients, respectively, indicating a favorable safety profile.
Relapsed or refractory mantle cell lymphoma has limited therapeutic options and poor survival after traditional chemotherapies or Bruton tyrosine kinase inhibitors. The high complete response rate and durable disease control observed with liso‑cel offer a promising new treatment avenue with manageable toxicity, particularly for patients with high‑risk features such as TP53 mutation or blastoid morphology.
Bizonyítékszint: Állatkísérletes. Állatmodellben vizsgálták.
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