Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT05826535
Brief Summary:
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Detailed Description:
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Five cohorts of participants will be enrolled:
Cohort 1: Participants who have not received a prior CAR T-cell product (CAR T naïve) and have received at least two or more prior lines of treatment (third-line or later).
Cohort 2: Participants who have received a prior CAR T-cell product (CAR T experienced) and have received at least two or more prior lines of treatment including one CAR T-cell therapy.
Cohort 3: Participants with refractory disease or relapse within one year of first-line therapy (second-line).
Cohort 4: Participants who have received prior T-cell engager (TCE) therapy and have received at least two or more prior lines of treatment including one TCE therapy.
Cohort 5: Participants receiving first-line treatment for high-risk large B-cell lymphoma who remain with disease on positron emission tomography scanning (PET-positive) after 2 to 3 cycles of standard-of-care chemoimmunotherapy (high-risk first-line).
Up to approximately 150 participants (across all cohorts) will be enrolled in the dose finding Phase 1 part of the study.
The Phase 2 pivotal study (PiNACLE) will expand enrollment of Cohort 1 to approximately 120 participants to further evaluate the safety and efficacy of LYL314.
LYL314 treatment consists of a single administration of CAR transduced autologous T-cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days.
Individual participants will remain in the active post-treatment follow-up (PTFU) period for approximately 2 years. Participants will continue in long-term follow-up (LTFU) for 15 years from LYL314 treatment.
Study:
NCT05826535
Study Brief:
Protocol Section:
NCT05826535