Treatment of aggressive large B-cell lymphoma with LYL314

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California-Irvine Medical Center
  Irvine, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• University of California, Los Angeles (UCLA) Medical Center
  Los Angeles, California, United States Recruiting
• Scripps Clinic
  San Diego, California, United States Recruiting
• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Medstar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Stephen Simko, MD
• Email: clinicaltrials@lyell.com
• Phone: 000-000-0000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.