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
Sponsor: Lyell Immunopharma, Inc.
Terminated
Pipeline Reprioritization
A PHASE1 clinical study on Advanced Breast Cancer and Advanced Lung Carcinoma, this trial is terminated or withdrawn. The trial is conducted by Lyell Immunopharma, Inc. and has accumulated 20 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)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 refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.
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 refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.
Status Flow
Change History
20 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE1
-
Sep 2025 — Present [monthly]
Terminated PHASE1
-
Aug 2025 — Sep 2025 [monthly]
Terminated PHASE1
Status: Active Not Recruiting → Terminated
-
Dec 2024 — Aug 2025 [monthly]
Active Not Recruiting PHASE1
Status: Recruiting → Active Not Recruiting
-
Oct 2024 — Dec 2024 [monthly]
Recruiting PHASE1
▶ Show 15 earlier versions
-
Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
-
Apr 2024 — Jul 2024 [monthly]
Recruiting PHASE1
-
Feb 2024 — Apr 2024 [monthly]
Recruiting PHASE1
-
Dec 2023 — Feb 2024 [monthly]
Recruiting PHASE1
-
Sep 2023 — Dec 2023 [monthly]
Recruiting PHASE1
-
Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE1
-
May 2023 — Aug 2023 [monthly]
Recruiting PHASE1
-
Apr 2023 — May 2023 [monthly]
Recruiting PHASE1
-
Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE1
-
Feb 2023 — Mar 2023 [monthly]
Recruiting PHASE1
-
Dec 2022 — Feb 2023 [monthly]
Recruiting PHASE1
-
Nov 2022 — Dec 2022 [monthly]
Recruiting PHASE1
-
Sep 2022 — Nov 2022 [monthly]
Recruiting PHASE1
-
Apr 2022 — Sep 2022 [monthly]
Recruiting PHASE1
First recorded
Mar 2022
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Lyell Immunopharma, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .