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Rondecabtagene autoleucel in aggressive B-cell non-Hodgkin lymphoma
NCT05826535Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2023
- Primary completion
- Dec 2028
- Countries
- 2
- Sponsor
- Lyell Immunopharma
- Modality
- CAR-T Cells
- Conditions
- non-Hodgkin lymphoma (NHL)diffuse large B-cell lymphoma (DLBCL)
01
Overview
Phase 2, open-label trial of rondecabtagene autoleucel in non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL) (6 cohorts), sponsored by Lyell Immunopharma. Primary endpoints: Safety and tolerability of a single dose of ronde-cel at Month 24 and Overall Response Rate at Month 24. Started May 2023; status: recruiting.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Ph1, 3rd or later line, 3L+ have not received prior CAR T (Cohort 1)
Phase 1 dose finding
Ph1 CAR T experienced, 3L+ received at least two or more prior lines of treatment (Cohort 2)
Phase 1 dose finding
Ph1, 2L Refractory/relapse within 1 year of 1st-line therapy & no prior CAR T (Cohort 3)
Phase 1 dose finding
Ph1 (T-cell engager experienced, 3L+) received at least 2 prior lines including 1 TCE (Cohort 4)
Phase 1 dose finding
Ph1 high risk 1st line, PET-positive after 2-3 cycles chemoimmunotherapy, no prior CAR T (Cohort 5)
Phase 1 dose finding
Ph2, 3rd or later line, have not received prior CAR T (Cohort 1)
Phase 2 pivotal expansion (PiNACLE)
03
Who it enrols
Adults with relapsed or refractory large B-cell lymphoma who have received at least 1-2 prior lines of therapy (depending on cohort), with adequate organ function and no active CNS involvement or recent systemic anti-cancer therapy.
04
Endpoints
Primary
Safety and tolerability of a single dose of ronde-cel
Overall Response Rate
Secondary
Efficacy of ronde-cel
Feasibility of treatment with ronde-cel
Pharmacokinetics of ronde-cel
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