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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05274451
Other study ID # LYL797-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 29, 2022
Est. completion date September 2026

Study information

Verified date February 2024
Source Lyell Immunopharma, Inc.
Contact Jackie Walling, MD, PhD
Phone 888-707-7917
Email clinicaltrials@lyell.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC) or non-small cell lung cancer (NSCLC). The first part of the study will determine the safe dose for the next part of the study, and will enroll TNBC and NSCLC patients. The second part of the study will test that dose in additional TNBC and NSCLC patients.


Description:

This Phase 1, single-arm, open-label, multi-center, dose-escalation and -expansion study will evaluate the safety and tolerability of LYL797, ROR1-targeting CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). The dose-escalation phase includes TNBC and NSCLC patients, and will investigate 4 dose levels to determine the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll both TNBC and NSCLC patients at the RP2D.


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Study Design


Related Conditions & MeSH terms

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Intervention

Biological:
LYL797
LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy

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Sponsors (1)

Lead Sponsor Collaborator
Lyell Immunopharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate incidence of dose-limiting toxicities (DLTs) Incidence of dose-limiting toxicities (DLTs) Up to 2 years
Primary Evaluate incidence of treatment-emergent adverse events (TEAEs) Incidence of treatment-emergent adverse events (TEAEs) Up to 2 years
Primary Evaluate severity of treatment-emergent adverse events (TEAEs) Severity of treatment-emergent adverse events (TEAEs) Up to 2 years
Primary Determine recommended Phase 2 Dose (RP2D) Dose-escalation phase to determine the recommended Phase 2 dose Up to 2 years
Secondary Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1 Overall response rate (ORR) by RECIST, version 1.1 Up to 2 years
Secondary Evaluate anti-tumor activity of LYL797 based on complete response (CR) rate by RECIST, version 1.1 Complete response (CR) rate by RECIST, version 1.1 Up to 2 years
Secondary Evaluate duration of response (DOR) Duration of response (DOR) Up to 2 years
Secondary Evaluate progression-free survival (PFS) Progression-free survival (PFS) Up to 2 years
Secondary Evaluate overall survival (OS) Overall survival (OS) Up to 2 years
Secondary Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples Maximum concentration of LYL797 (Cmax) Up to 2 years
Secondary Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples Time to Cmax (Tmax) Up to 2 years
Secondary Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB) Area under the concentration-time curve (AUC) Up to 2 years
Secondary Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples Persistence of LYL797 in PB Up to 2 years
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