Triple Negative Breast CancerPhase 1NCT05274451
A Study to Investigate LYL797 in Adults With Solid Tumors
A Phase 1 study testing LYL797 in people with Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Lyell Immunopharma, Inc. at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Non-small Cell Lung Cancer
- What is being tested?
- LYL797
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 18 sitesUnited States
- Study dates
- 29 Mar 2022to 27 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
University of Chicago
Chicago, Illinois, 60637
Karmanos Cancer Institute
Detroit, Michigan, 48201
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
University of Miami
Miami, Florida, 33136
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Sarah Cannon Research Institute and Tennessee Oncology
Nashville, Tennessee, 37203
Yale New Haven Hospital
New Haven, Connecticut, 06510
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Sidney Kimmel Cancer Center, Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Oregon Health and Science University Hospital
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55902
University of California, Los Angeles
Santa Monica, California, 90404
Mayo Clinic
Scottsdale, Arizona, 85259
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10461
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
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.
Read the detailed description
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.
- 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
- Being tested
- LYL797
- Keywords
- CAR T-cell therapy, CAR T, CAR T-cell, CAR-T, CAR-T cell therapy, CAR-T cell, ROR1, ROR1+, ROR1 positive, cell therapy, immunotherapy, relapsed, refractory, solid tumor, advanced, metastatic, breast cancer, lung cancer, triple negative breast cancer, non small cell lung cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Recurrence, Breast Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Endometrial Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYL797Biological
LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental LYL797 | Experimental | ROR1-targeted CAR T cells Receives: Biological: LYL797 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate incidence of dose-limiting toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 years
Evaluate severity of treatment-emergent adverse events (TEAEs)
Severity of treatment-emergent adverse events (TEAEs)
Measured: Up to 2 years
Determine recommended Phase 2 Dose (RP2D)
Dose-escalation phase to determine the recommended Phase 2 dose
Measured: Up to 2 years
Secondary outcomes (8)
Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1
Overall response rate (ORR) by RECIST, version 1.1
Measured: Up to 2 years
Evaluate duration of response (DOR)
Duration of response (DOR)
Measured: Up to 2 years
Evaluate progression-free survival (PFS)
Progression-free survival (PFS)
Measured: Up to 2 years
Evaluate overall survival (OS)
Overall Survival (OS)
Measured: Up to 2 years
Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples
Maximum concentration of LYL797 (Cmax)
Measured: Up to 2 years
Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples
Time to Cmax (Tmax)
Measured: Up to 2 years
Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB)
Area under the concentration-time curve (AUC)
Measured: Up to 2 years
Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples
Time to last detectable LYL797, Tlast
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start29 Mar 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Why it stopped: Pipeline Reprioritization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label, dose-escalation and -expansion study
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyell Immunopharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jackie Walling, MBChB, PhD, Study director, Lyell Immunopharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274451
- Sponsor's protocol ID
- LYL797-101
- Status last verified
- Jun 2025
- First submitted
- 18 Feb 2022
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05274451
- Acronym / sponsor ID
- LYL797-101
- 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
- Keywords
- CAR T-cell therapy, CAR T, CAR T-cell, CAR-T, CAR-T cell therapy, CAR-T cell, ROR1, ROR1+
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pipeline Reprioritization
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Lyell Immunopharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label, dose-escalation and -expansion study
| Arm | Type | Receives |
|---|---|---|
| Experimental LYL797 | Experimental | Biological: LYL797ROR1-targeted CAR T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYL797LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy | Biological | Experimental LYL797 |
Primary outcome
Evaluate incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
Incidence of dose-limiting toxicities (DLTs)
Evaluate incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Incidence of treatment-emergent adverse events (TEAEs)
Evaluate severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 2 years
Severity of treatment-emergent adverse events (TEAEs)
Determine recommended Phase 2 Dose (RP2D)
Time frame: Up to 2 years
Dose-escalation phase to determine the recommended Phase 2 dose
8 secondary outcomes
Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1
Time frame: Up to 2 years
Evaluate duration of response (DOR)
Time frame: Up to 2 years
Evaluate progression-free survival (PFS)
Time frame: Up to 2 years
Evaluate overall survival (OS)
Time frame: Up to 2 years
Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples
Time frame: Up to 2 years
Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples
Time frame: Up to 2 years
Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB)
Time frame: Up to 2 years
Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Pipeline Reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackie Walling, MBChB, PhD study director
Lyell Immunopharma, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LYL797 in people with Triple Negative Breast Cancer and TNBC - Triple-Negative Breast Cancer, run by Lyell Immunopharma, Inc. at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Pipeline Reprioritization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate incidence of dose-limiting toxicities (DLTs) (time frame: Up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.