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CAR T-cell Therapy

LYL797 for Breast and Lung Cancer

Phase 1
Recruiting
Research Sponsored by Lyell Immunopharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
≥ 18 years of age at time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will study a new cancer treatment, called LYL797, in patients who have triple negative breast cancer or non-small cell lung cancer that has come back or does not respond to other treatments. The first part of the trial will test different doses of LYL797 to find a safe dose. The second part of the trial will give that dose to additional patients to see if it is effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Possible side effects aren't detailed but may include symptoms typical of CAR T-cell therapies such as fever, fatigue, immune reactions affecting different organs (cytokine release syndrome), neurological events among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am 18 years old or older.
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I am of childbearing age and my pregnancy test was negative.
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My cancer is triple-negative breast cancer or non-small cell lung cancer, cannot be surgically removed, and tests positive for ROR1.
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I have at least two detectable cancer lesions.
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My organs and bone marrow are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine recommended Phase 2 Dose (RP2D)
Evaluate incidence of dose-limiting toxicities (DLTs)
Evaluate incidence of treatment-emergent adverse events (TEAEs)
+1 more
Secondary outcome measures
Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples
Evaluate anti-tumor activity of LYL797 based on complete response (CR) rate by RECIST, version 1.1
Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental LYL797Experimental Treatment1 Intervention
ROR1-targeted CAR T cells

Find a Location

Who is running the clinical trial?

Lyell Immunopharma, Inc.Lead Sponsor
2 Previous Clinical Trials
358 Total Patients Enrolled
Roo Vold, MDStudy DirectorLyell Immunopharma, Inc.
Jackie Walling, MD, PhDStudy DirectorLyell Immunopharma, Inc.
1 Previous Clinical Trials
250 Total Patients Enrolled

Media Library

LYL797 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05274451 — Phase 1
Lung Cancer Research Study Groups: Experimental LYL797
Lung Cancer Clinical Trial 2023: LYL797 Highlights & Side Effects. Trial Name: NCT05274451 — Phase 1
LYL797 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05274451 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for prospective patients in this trial?

"Confirmed, as per clinicaltrials.gov this experiment is actively recruiting participants. It was initially published on March 29th 2022 and the last update to its information came on November 11th of the same year."

Answered by AI

How many participants have signed up for this trial?

"The sponsor of this medical study, Lyell Immunopharma Inc., is aiming to recruit 54 participants across two sites: the Karmanos Cancer Institute in Detroit and MD Anderson Cancer Center in Arizona. In order for these individuals to be eligible, they must meet all specified criteria."

Answered by AI

Has the Food and Drug Administration issued a green light for LYL797?

"The safety of LYL797 was given a rating of 1, as it is currently in Phase 1 trials with limited evidence for its efficacy and security."

Answered by AI

To what extent have hospitals implemented this trial?

"This clinical trial is presently recruiting participants from 12 different medical centres, 3 of which are in Detroit, Scottsdale and Houston. It might be prudent to select the closest clinic so that you can minimize travel requirements if accepted as a participant."

Answered by AI

What is the projected outcome of this clinical experiment?

"This two-year assessment will evaluate the emergence of adverse effects (TEAEs) associated with treatment. The secondary objectives are to measure progression-free survival, concentration time curves in peripheral blood samples, and persistence of LYL797 CAR T cells within those same specimens."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
Roswell Park Comprehensive Cancer Center
Sidney Kimmel Cancer Center, Jefferson University Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Sidney Kimmel Cancer Center, Jefferson University Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate LYL797 in Adults With Solid Tumors
2022. "A Study to Investigate LYL797 in Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05274451.
All > Non Small Cell Lung Cancer > Nsclc
~15 spots leftby Mar 2025
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