LYL797

P1, N=100, Active, not recruiting, Lyell Immunopharma, Inc. | Recruiting --> Active, not recruiting

P1, N=100, Recruiting, Lyell Immunopharma, Inc. | N=54 --> 100 | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Mar 2025 --> Dec 2025

P1, N=54, Recruiting, Lyell Immunopharma, Inc.

After successful LYL797 manufacturing, pts receive fludarabine and cyclophosphamide followed by a single infusion of LYL797 at the protocol-assigned dose level. Study objectives include assessment of safety and tolerability (primary), as well as anti-tumor activity and pharmacokinetics (secondary) of LYL797. Additional exploratory objectives include evaluation of the effects of Lyell’s genetic and epigenetic reprogramming technologies on T-cell phenotype and activity, as well as evaluation of the relationship between ROR1 expression and LYL797 activity.

After leukapheresis and manufacturing, pts receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by LYL797 infusion at the protocol-assigned dose level. Primary objectives include LYL797 RP2D determination and safety and tolerability; secondary objectives include anti-tumor activity and PK. The trial began screening in March 2022.

These studies collectively demonstrate that Gen-R and Epi-R technologies can give rise to enhanced and prolonged anti-tumor functional capacity of CAR T-cell therapy in solid tumors. Based on these promising preclinical data, LYL797 is being studied in a phase I clinical trial to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with ROR1+ TNBC and NSCLC.

P1, N=54, Recruiting, Lyell Immunopharma, Inc. | Not yet recruiting --> Recruiting

P1, N=54, Not yet recruiting, Lyell Immunopharma, Inc.

In preclinical studies LYL797 cells reprogrammed with Gen-R and Epi-R led to improved functional activity in the presence of ROR1+ tumor cells compared to conventional ROR1 CAR T cells.Additional studies are underway to determine the mechanisms by which antitumor activity of LYL797 in ROR1-positive solid tumor xenograft models is enhanced. LYL797 is anticipated to enter into Phase 1 clinical trials for TNBC and NSCLC in 2022.