A Study to Investigate LYL797 in Adults With Solid Tumors

Lyell Immunopharma

Status and phase

Enrolling

Phase 1

Conditions

Relapsed Cancer

NSCLC, Recurrent

NSCLC Stage IV

TNBC - Triple-Negative Breast Cancer

Non Small Cell Lung Cancer

Non-Small Cell Carcinoma of Lung, TNM Stage 4

Recurrent NSCLC

Non Small Cell Lung Cancer Metastatic

Advanced Lung Carcinoma

Non-small Cell Lung Cancer

Triple Negative Breast Cancer

Recurrent Breast Cancer

Relapse/Recurrence

NSCLC

Advanced Breast Cancer

Treatments

Biological: LYL797

Study type

Interventional

Funder types

Industry

Identifiers

NCT05274451

LYL797-101

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥ 18 years of age at time of informed consent
Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable that is ROR1+ by central laboratory immunohistochemistry (IHC)
Measurable disease including a target lesion and an additional lesion for biopsy
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate organ and marrow function
Women of childbearing potential must have a negative pregnancy test at screening
All participants must agree to practice highly effective methods of contraception

Exclusion criteria

Prior treatment with any adoptive T-cell therapy or anti-ROR1 therapy
Prior solid organ transplantation
Active, untreated brain metastasis or leptomeningeal disease; stable, treated brain involvement by disease is allowed
Untreated or active infection at the time of screening or leukapheresis
HIV-positive, HTLV-1-positive, active acute or chronic HBV or HCV, or active tuberculosis
Impaired cardiac function or clinically significant cardiac disease
Uncontrolled pleural or pericardial effusion
Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
Required chronic anticoagulation, such as warfarin, low molecular weight heparin, or Factor Xa inhibitors
Pregnant or lactating/nursing women