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.

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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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05274451

Recruitment Status:

Recruiting

Sponsor:

Lyell Immunopharma, Inc.

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There are 6 Locations for this study

See Locations Near You

Yale New Haven Hospital
New Haven Connecticut, 06510, United States More Info
Michael Hurwitz, MD
Contact
203-785-4095
Mayo Clinic
Jacksonville Florida, 32224, United States More Info
Hemant Murthy, MD
Contact
855-776-0015
Oregon Health and Science University Hospital
Portland Oregon, 97239, United States More Info
Richard Maziarz, MD
Contact
503-494-1080
[email protected]
Sidney Kimmel Cancer Center, Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Babar Bashir, MD
Contact
215-955-1661
Sarah Cannon Research Institute and Tennessee Oncology
Nashville Tennessee, 37203, United States More Info
David Spigel, MD
Contact
844-482-4812
Froedtert Hospital, Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Lubna Chaudhary, MD
Contact
414-805-3666

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT05274451

Recruitment Status:

Recruiting

Sponsor:


Lyell Immunopharma, Inc.

How clear is this clinincal trial information?

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