Breast Cancer Clinical Trial
A Study to Investigate LYL797 in Adults With Solid Tumors
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 patients only. The second part of the study will test that dose in additional TNBC patients 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 (TNBC only), and will investigate 4 dose levels to determine the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll both TNBC and NSCLC at the RP2D.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 6 Locations for this study
Philadelphia Pennsylvania, 19107, United States More Info
Nashville Tennessee, 37203, United States More Info
Milwaukee Wisconsin, 53226, United States More Info
How clear is this clinincal trial information?