No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
270 (estimated)
Sponsor
Lyell Immunopharma, Inc. · Industry
Who this trial is looking for
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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.
Trial Locations
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State
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Status
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 li…
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.
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