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A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy

RecruitingPhase 3Ages 18 Years - anyAllLyell Immunopharma, Inc.
NCT07188558 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.

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📋 Eligibility rules (as published)
Key Inclusion Criteria: 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy 2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022) * Diffuse large B-cell lymphoma (DLBCL) * Transformations of indolent B-cell lymphomas (excluding Richter's transformation) * DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS) * Primary mediastinal large B-cell lymphoma (PMBCL) * Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B) 3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy 4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: 1. Patients ineligible to receive CD19 CAR T-cell therapy 2. Primary CNS lymphoma 3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation) 4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years 5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment 6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply
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What it tests

  • rondecabtagene autoleucel
  • axicabtagene ciloleucel
  • lisocabtagene maraleucel
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Where

36 sites
Banner MD Anderson Cancer Center
Gilbert, United States
Honor Health
Scottsdale, United States
Mayo Clinic Arizona
Scottsdale, United States
University of Arkansas
Little Rock, United States
Cedars-Sinai Medical Center
Los Angeles, United States
University of California, Los Angeles (UCLA)
Los Angeles, United States
University of California, Irvine
Orange, United States
University of Colorado
Aurora, United States

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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