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.
Ready to participate?
Review the details below, then apply to join this clinical trial.
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
This trial is looking for adults with aggressive large B-cell lymphoma who have had prior treatments that didn't work. Participants will receive a new type of therapy that targets specific cancer cells.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I can provide signed permission to join the trial
I have been diagnosed with large B-cell lymphoma
I have had at least one prior treatment
I have cancer that has come back or hasn't responded to treatment
I have at least one measurable tumor
I have a good performance status
I have enough blood cells to participate
You may not be able to join if
I have had cancer other than certain skin cancers in the past 3 years
I have current cancer in my brain or central nervous system
I have heart lymphoma or specific types of virus-related lymphoma
I have an ongoing cancer emergency
I have had recent cancer treatment or radiation
I have unresolved side effects from previous treatment
I have had a stem cell transplant or organ transplant
I have an immune deficiency or severe autoimmune disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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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City
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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