CD19 CAR T-cell therapy (GLPG5101) for relapsed or refractory B-cell non-Hodgkin lymphoma (ATALANTA-1): phase 1 results from a single-arm, multicentre, phase 1/2 study.
Marie José Kersten, Maria T Kuipers, Pim G N J Mutsaers et al.
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In 30 seconds
This phase 1/2 study evaluated the safety of GLPG5101, a fresh CD19 CAR T-cell therapy, in 24 patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The study demonstrated that all patients experienced grade 3 or higher treatment-emergent adverse events, with the most common being neutropenia in 96% of cases. The recommended phase 2 dose was established at 110 × 10^6 viable CAR T-cells.
Key findings
- All 23 patients in the safety analysis had grade 3 or higher treatment-emergent adverse events.
- The most common adverse event was neutropenia, occurring in 22 patients (96%).
- Four treatment-related deaths were reported, including one due to intra-abdominal hemorrhage.
Why it matters
The study highlights the potential for decentralized manufacturing of CAR T-cell therapies, which may improve access and reduce costs for patients with relapsed or refractory B-cell non-Hodgkin lymphoma. Understanding the safety profile is crucial for clinicians considering this treatment option.