Status:
TERMINATED
A Study to Investigate LYL797 in Adults With Solid Tumors
Lead Sponsor:
Lyell Immunopharma, Inc.
Conditions:
Triple Negative Breast Cancer
TNBC - Triple-Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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), non-small cell l...
Detailed Description
This Phase 1, single-arm, open-label, multi-center, dose-escalation and expansion study will evaluate the safety and tolerability of LYL797, ROR1- targeted CAR T cells, in adults with relapsed and/or ...
Eligibility Criteria
Inclusion
- I
- ≥ 18 years of age at time of informed consent
- Confirmation of ROR1 expression from a pretreatment tumor sample
- Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable
- Platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer.
- Endometrial cancer.
- 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
- Prior treatment with any adoptive T-cell therapy or other anti-ROR1 therapy
- Prior solid organ transplantation
- Active, untreated brain metastasis or leptomeningeal disease; however, stable, treated brain metastases are allowed
- Untreated or active infection at the time of screening or leukapheresis
- HIV-positive, HTLV-1-positive, active acute HAV, acute or chronic HBV or HCV, or active tuberculosis
- Impaired cardiac function or clinically significant cardiac disease
- Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequent), or lymphangitis carcinomatosis
- History of interstitial pneumonitis or pulmonary fibrosis.
- Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
- Pregnant or lactating/nursing women
Key Trial Info
Start Date :
March 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT05274451
Start Date
March 29 2022
End Date
November 27 2024
Last Update
July 1 2025
Active Locations (18)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
University of California, Los Angeles
Santa Monica, California, United States, 90404
3
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
4
Georgetown University
Washington D.C., District of Columbia, United States, 20007