A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Part of paid clinical trials in Gilbert, Arizona.
- Sponsor
- Lyell Immunopharma, Inc.
- Study ID
- NCT07188558
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Diffuse Large B Cell Lymphoma Refractory
- Diffuse Large B Cell Lymphoma Relapsed
- Large B-cell Lymphoma
- Lymphoma, B-Cell
- Non-Hodgkin Lymphoma
- Non-Hodgkin Lymphoma Refractory/ Relapsed
- Refractory Non-Hodgkin Lymphoma
- Relapsed Non-Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rondecabtagene autoleucel — BIOLOGICALAn autologous, dual-targeting CD19/20 CAR T-cell candidate.
- axicabtagene ciloleucel — BIOLOGICALAn autologous CD19 CAR T-cell therapy
- lisocabtagene maraleucel — BIOLOGICALAn autologous CD19 CAR T-cell therapy
Study Details
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.
Key Dates
- Start date
- Jan 12, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2029
- Completion
- Jan 31, 2032
Study Design
- Enrollment
- 400 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Rondecabtagene autoleucel
- Active Comparator: Investigator's Choice CD19axicabtagene ciloleucel, lisocabtagene maraleucel
Primary Outcome Measure
Event free survival [ Time Frame: 36 months ]
Central Contacts
- David Shook, MD000-000-0000
- Mary Lessig, MS000-000-0000
Locations (38)
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