A Study to Investigate LYL797 in Adults With Solid Tumors
NCT05274451 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57
Last updated 2025-07-01
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 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.
Conditions
- Triple Negative Breast Cancer
- TNBC - Triple-Negative Breast Cancer
- Non-small Cell Lung Cancer
- Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer Metastatic
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
- Advanced Breast Cancer
- Advanced Lung Carcinoma
- NSCLC
- NSCLC, Recurrent
- NSCLC Stage IV
- Relapsed Cancer
- Relapse/Recurrence
- Recurrent Breast Cancer
- Recurrent NSCLC
- Platinum-resistant Ovarian Cancer
- Ovarian Cancer
- Primary Peritoneal Carcinoma
- Fallopian Tube Cancer
- Endometrial Cancer
- Endometrioid Tumor
- High Grade Serous Carcinoma
- Ovarian Epithelial Cancer
Interventions
- BIOLOGICAL
-
LYL797
LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy
Sponsors & Collaborators
-
Lyell Immunopharma, Inc.
lead INDUSTRY
Principal Investigators
-
Jackie Walling, MBChB, PhD · Lyell Immunopharma, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-29
- Primary Completion
- 2024-11-27
- Completion
- 2024-11-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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