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New treatment option for Relapsed Non-Hodgkin Lymphoma
Official title Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT05826535
What this study is testing
What is Rondecabtagene autoleucel (ronde-cel)?
Rondecabtagene autoleucel (ronde-cel) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Willing and able to provide written informed consent
- Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus...
- Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
- Relapsed or refractory disease.
You likely can't join if
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
- Active central nervous system involvement
- History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
- Ongoing or impending oncologic emergency
- Recent systemic anti-cancer therapy or radiation
- Ongoing non-hematologic toxicities due to prior therapy
See the full eligibility criteria
- Age 18 years or older
- Willing and able to provide written informed consent
- Histologically confirmed LBCL, including the following types defined by the World Health Organization (WHO 2022) or International Consensus Classification (2022)
- Received at least two prior lines of therapy for Cohorts 1, 2, and 4 and one prior line of therapy for Cohort 3
- Relapsed or refractory disease.
- At least 1 measurable lesion (per Lugano classification)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or ECOG 0 to 2 (Cohort 5)
- Absolute neutrophil count (ANC) ≥ 1000/µL
- Platelet count ≥ 50,000/µL
- Absolute lymphocyte count (ALC) ≥ 200/µL Other protocol-defined criteria apply.
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for at least 3 years
- Active central nervous system involvement
- History of cardiac lymphoma involvement or Epstein-Barr virus (EBV)+ lymphoma
- Ongoing or impending oncologic emergency
- Recent systemic anti-cancer therapy or radiation
- Ongoing non-hematologic toxicities due to prior therapy
- History of allogeneic stem cell or solid organ transplantation
- Autologous stem cell transplantation within 6 weeks
- 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...
- Primary immunodeficiency
- History of autoimmune disease resulting in end organ injury or requiring recent therapy Other protocol-defined criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Augusta, Georgia, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- Shreveport, Louisiana, United States
- Grand Rapids, Michigan, United States
- Omaha, Nebraska, United States
- Hackensack, New Jersey, United States
- Albuquerque, New Mexico, United States
- Buffalo, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Los Angeles, California, United States; San Diego, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States; Augusta, Georgia, United States and 26 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.