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TerminatedPhase 1NCT05274451
Official study title

A Study to Investigate LYL797 in Adults With Solid Tumors

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLYL797

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 1, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?Lyell Immunopharma, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Lyell Immunopharma, Inc.
Interventions being studied
Biological: LYL797
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→
Treatment approach
Cell or gene therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Mayo ClinicScottsdale, Arizona
  • University of California, Los AngelesSanta Monica, California
  • Yale New Haven HospitalNew Haven, Connecticut
  • Georgetown UniversityWashington D.C., District of Columbia
  • Mayo ClinicJacksonville, Florida
  • University of MiamiMiami, Florida
  • University of ChicagoChicago, Illinois
  • Karmanos Cancer InstituteDetroit, Michigan
  • Mayo ClinicRochester, Minnesota
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Montefiore Medical CenterThe Bronx, New York
  • University of OklahomaOklahoma City, Oklahoma

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 1, 2025. Always confirm current availability with the study team.

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