NCT05826535 · Lyell Immunopharma, Inc.
Study of LYL314 in Aggressive Large B-Cell Lymphoma
What this study is about
This is a Phase 1/2, multi-center, where both patients and doctors know the treatment given study evaluating the safety and effectiveness of LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
View original scientific description
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Interventions
DRUG
Rondecabtagene autoleucel (ronde-cel)
CAR T-cell therapy
DRUG
Fludarabine
Conditioning chemotherapy
DRUG
Cyclophosphamide
Conditioning chemotherapy
Primary outcome measures
Phase 1: Evaluate the safety and tolerability of a single dose of ronde-cel administered as a single agent
Time frame: Baseline to Month 24
Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs)
Phase 2: Estimate the efficacy of ronde-cel, as measured by overall response rate (ORR)
Time frame: Baseline to Month 24
ORR based on Independent Review Committee (IRC) assessment per Lugano criteria
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older at time of informed consent 2. Willing and able to provide written informed consent 3. Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO 2017):
- DLBCL arising from follicular lymphoma (transformed FL, tFL)
- Primary mediastinal (thymic) large B-cell lymphoma (PMBCL)
- High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement (HGBL)
- Grade 3B follicular lymphoma/Large cell follicular lymphoma (FL3B) 4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3. Prior therapy must have included:
- Anti-CD20 monoclonal antibody, and
- An anthracycline containing chemotherapy regimen
- Participants with tFL must have received at least one of their prior lines of therapy after transformation to DLBCL 4b. Cohort 5 (High-risk first-line) participants must hav
Where
- Irvine, California
- Los Angeles, California
- San Diego, California
- Denver, Colorado
- Washington D.C., District of Columbia
- Augusta, Georgia
- Indianapolis, Indiana
- Iowa City, Iowa
- Louisville, Kentucky
- Shreveport, Louisiana
- Grand Rapids, Michigan
- Omaha, Nebraska
And 18 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations