A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 3
Where in Canada
- Princess Margaret Cancer CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lyell Immunopharma, Inc.
- Trial code
- NCT07188558
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting
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.
Inclusion: CAR T cell naïve and eligible to receive a CD19 CART-cell therapy; 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); Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy; Measurable disease by presence of [18F]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Adequate hematological, renal, hepatic, pulmonary, and cardiac function.
Exclusion: Patients ineligible to receive CD19 CAR T-cell therapy; Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment; Active autoimmune disease requiring ongoing systemic immunosuppressive therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; 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; Primary CNS lymphoma; 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).