NCT05826535 Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
| NCT ID | NCT05826535 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Lyell Immunopharma, Inc. |
| Condition | Relapsed Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 270 participants |
| Start Date | 2023-05-09 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 270 participants in total. It began in 2023-05-09 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of rondecabtagene autoleucel (ronde-cel) also known as LYL314, a dual-targeting chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive large B-cell lymphoma.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05826535 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05826535 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05826535 currently recruiting?
Yes, NCT05826535 is actively recruiting participants. Contact the research team at clinicaltrials@lyell.com for enrollment information.
Where is the NCT05826535 trial being conducted?
This trial is being conducted at Irvine, United States, Los Angeles, United States, Los Angeles, United States, San Diego, United States and 11 additional locations.
Who is sponsoring the NCT05826535 clinical trial?
NCT05826535 is sponsored by Lyell Immunopharma, Inc.. The trial plans to enroll 270 participants.