LYL797 for Breast and Lung Cancer

Recruiting at 19 trial locations

Overseen By Jackie Walling, MBChB, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lyell Immunopharma, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Organ transplant, Brain metastasis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called LYL797, which uses modified immune cells to target and kill hard-to-treat breast and lung cancer cells. The study aims to find a safe dose and see how well it works in patients whose cancers have not responded to other treatments.

Do I need to stop my current medications to join the trial?

The trial requires that you stop taking systemic corticosteroids or other immunosuppressive medications at least 14 days before a specific procedure called leukapheresis. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Research Team

Jackie Walling, MBChB, PhD

Principal Investigator

Lyell Immunopharma, Inc.

Eligibility Criteria

Adults with advanced, ROR1+ triple negative breast cancer or non-small cell lung cancer that's come back or hasn't responded to treatment. They must be in good physical condition, have proper organ and marrow function, not be pregnant, and agree to use effective birth control. People can't join if they've had certain other treatments like adoptive T-cell therapy, have untreated brain metastasis, active infections including HIV/HBV/HCV/TB, serious heart issues, uncontrolled fluid around lungs/heart or are on immunosuppressants.

Inclusion Criteria

I am fully active or can carry out light work.

I am 18 years old or older.

I am of childbearing age and my pregnancy test was negative.

Exclusion Criteria

I am on long-term blood thinners like warfarin.

I do not have active, untreated brain cancer spread but stable, treated brain involvement is okay.

I have not had T-cell or anti-ROR1 therapy before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Dose-escalation phase to determine the recommended Phase 2 dose (RP2D) for LYL797

Up to 28 days

Dose-Expansion

Dose-expansion phase to test the RP2D in additional patients

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• LYL797

Trial Overview LYL797 is being tested for safety and the right dose in patients with specific types of breast and lung cancers. The first part finds a safe dose by starting low then increasing it for new groups of patients (dose escalation). Once found, the second part tests this dose in more patients (dose expansion).

Participant Groups

Group I: Experimental LYL797 Experimental Treatment 1 Intervention

ROR1-targeted CAR T cells

Who Is Running the Clinical Trial?

Lyell Immunopharma, Inc.

Lead Sponsor

Trials

5

Recruited

610+