Lyell Immunopharma has reported new clinical data from the Phase I/II clinical trial of autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate, LYL314, along with data from those with large B-cell lymphoma (LBCL) in the third or later line (3L+) setting.
In the study, 25 subjects treated in the 3L+ setting showed an 88% overall response rate (ORR) and a 72% complete response rate (CRR).
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Notably, 71% of those who achieved a complete response maintained it for six months or more.
The PiNACLE trial, an extension of the trial for R/R LBCL subjects in the 3L+ setting, is currently in progress.
Lyell noted that as of 15 April 2025, 51 CAR T-naive subjects with R/R LBCL had been treated with the therapy.
The efficacy evaluable population included 36 subjects with day 84 evaluations or earlier disease progression or mortality.
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By GlobalDataThe participants’ demographics and baseline disease characteristics were reflective of a high-risk group, with median ages of 65 and 69 years in the 3L+ and second-line (2L) settings, respectively.
In addition, 49 patients received the recommended Phase II dose of 100 x 10⁶ CAR T cells, and CD19/CD20 screening was not needed before enrolment.
In the 2L group, with a five-month median follow-up, the ORR was 91%, with 64% achieving a complete response.
Notably, all subjects with a complete response maintained it at their final evaluation, including three patients at six months or more.
The safety profile was said to be manageable and appropriate for outpatient administration, observed across 51 subjects from both the 3L+ and 2L cohorts.
According to the company, LYL314 showed quick and durable depletion of B cells up to the 12-month evaluation.
The therapy previously secured the Food and Drug Administration’s fast track and regenerative medicine advanced therapy (RMAT) designations.
Lyell Immunopharma CEO and president Lynn Seely said: “Based on these robust data, and our recent end-of-Phase I meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026.”
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