NCT05274451TerminatedPhase 1
A Study to Investigate LYL797 in Adults With Solid Tumors
A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Reason given: Pipeline Reprioritization
Brief summary (registry, in English)
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 lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 18 Feb 2022
- Start date
- 29 Mar 2022
- Primary completion date
- 27 Nov 2024
- Lead sponsor
- Lyell Immunopharma, Inc.
- Diseases
- Metastatic breast cancer, Triple-negative breast cancer, Lung cancer, Ovarian cancer, Endometrial cancer
- NCT number
- NCT05274451
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with any adoptive T-cell therapy or other anti-ROR1 therapy
- Prior solid organ transplantation
- Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis
Other illness
- 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
- History of interstitial pneumonitis or pulmonary fibrosis.
Other
- Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequent), or lymphangitis carcinomatosis
- Pregnant or lactating/nursing women
Criteria the registry did not label
- IInclusion Criteria:
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago | Chicago | United States | Unknown status |
| Karmanos Cancer Institute | Detroit | United States | Unknown status |
| MD Anderson Cancer Center | Houston | United States | Unknown status |
| Mayo Clinic | Jacksonville | United States | Unknown status |
| University of Miami | Miami | United States | Unknown status |
| Froedtert Hospital/Medical College of Wisconsin | Milwaukee | United States | Unknown status |
| Sarah Cannon Research Institute and Tennessee Oncology | Nashville | United States | Unknown status |
| Yale New Haven Hospital | New Haven | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center | New York | United States | Unknown status |
| University of Oklahoma | Oklahoma City | United States | Unknown status |
| Sidney Kimmel Cancer Center, Jefferson University Hospital | Philadelphia | United States | Unknown status |
| Oregon Health and Science University Hospital | Portland | United States | Unknown status |
| Mayo Clinic | Rochester | United States | Unknown status |
| University of California, Los Angeles | Santa Monica | United States | Unknown status |
| Mayo Clinic | Scottsdale | United States | Unknown status |
| Fred Hutchinson Cancer Research Center | Seattle | United States | Unknown status |
| Montefiore Medical Center | The Bronx | United States | Unknown status |
| Georgetown University | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.