Lyell’s Ronde-cel Enters First Head-to-Head CAR-T Trial in Aggressive Lymphoma
Event summary
- Lyell dosed first patient in PiNACLE-H2H Phase 3 trial comparing ronde-cel vs. approved CAR-T therapies in second-line aggressive lymphoma.
- PiNACLE-H2H will enroll 400 patients across US, Canada, and Australia with event-free survival as primary endpoint.
- Ronde-cel’s PiNACLE single-arm trial (third-line+) aims for 2027 BLA submission after showing 93% response rate in Phase 1/2 data.
- Ronde-cel combines CD19/CD20 targeting with proprietary manufacturing for enhanced T-cell persistence.
The big picture
This trial marks the first direct comparison between CAR-T therapies in lymphoma, testing Lyell’s claim that ronde-cel’s dual-targeting and manufacturing enhancements create a best-in-class profile. The move comes as CAR-T therapies face pressure to demonstrate value in earlier treatment lines where competition with chemotherapy and antibody regimens intensifies. Lyell’s ability to execute this complex trial will be critical to differentiating its technology platform.
What we're watching
- Clinical Superiority
- Whether ronde-cel’s dual-targeting design can demonstrate meaningful efficacy advantages over established CAR-T therapies in head-to-head comparison.
- Regulatory Momentum
- The pace at which Lyell advances ronde-cel through approvals after PiNACLE data submission in 2027.
- Commercial Viability
- How Lyell positions ronde-cel in second-line lymphoma where it will compete directly with Bristol Myers Squibb’s lisocabtagene and Kite’s axicabtagene.
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