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Treatment of aggressive large B-cell lymphoma with LYL314

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Rondecabtagene Autoleucel, a CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cell Therapy in Participants With Aggressive B-Cell Non-Hodgkin Lymphoma

Phase1; Phase2 Interventional Lyell Immunopharma, Inc. · NCT05826535

This study is testing a new CAR T-cell therapy called LYL314 to see if it can effectively treat aggressive large B-cell lymphoma in different groups of patients.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorLyell Immunopharma, Inc. Industry-sponsored
Drugs / interventionsradiation, chimeric antigen receptor, CAR T, chemotherapy, cyclophosphamide, fludarabine
Locations32 sites (Irvine, California and 31 other locations)
Trial IDNCT05826535 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of LYL314, a dual-targeting CAR T-cell therapy aimed at treating aggressive large B-cell lymphoma. Participants are divided into five cohorts based on their treatment history and disease status, including those who are CAR T naïve, CAR T experienced, and those with refractory disease. The study consists of a Phase 1 dose-finding part with approximately 150 participants, followed by a Phase 2 pivotal study focusing on further evaluating the treatment in a larger cohort. The trial is open-label and multi-center, involving several prominent medical institutions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed aggressive non-Hodgkin lymphoma who have received multiple prior lines of therapy.

Not a fit: Patients with early-stage lymphoma or those who have not undergone prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with aggressive large B-cell lymphoma who have limited treatment alternatives.

How similar studies have performed: Other studies utilizing CAR T-cell therapies have shown promising results in similar patient populations, indicating a potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age 18 years or older
2. Willing and able to provide written informed consent
3. Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
4. Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
5. Relapsed or refractory disease.
6. At least 1 measurable lesion (per Lugano classification)
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
8. Absolute neutrophil count (ANC) ≥ 1000/µL
9. Platelet count ≥ 50,000/µL
10. Absolute lymphocyte count (ALC) ≥ 200/µL

Other protocol-defined criteria apply.

Exclusion Criteria:

1. History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
2. Active central nervous system involvement
3. History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
4. Ongoing or impending oncologic emergency
5. Recent systemic anti-cancer therapy or radiation
6. Ongoing non-hematologic toxicities due to prior therapy
7. History of allogeneic stem cell or solid organ transplantation
8. Autologous stem cell transplantation within 6 weeks
9. History of prior genetically modified cell therapy (Cohorts 1, 3, 4, 5) or no other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), or lisocabtagene maraleucel (liso-cel) (Cohort 2).
10. Primary immunodeficiency
11. History of autoimmune disease resulting in end organ injury or requiring recent therapy

Other protocol-defined criteria apply.

Where this trial is running

Irvine, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaNon-Hodgkin LymphomaLarge B-cell LymphomaCAR T-cellCD19/20CD19CD20
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.