Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rondecabtagene autoleucel (ronde-cel), LYL314
Rondecabtagene autoleucel · 2 trials · 9 indications
The time interval from treatment initiation until the occurrence of a specific event of interest.
Incidence of dose-limiting toxicities (DLTs) and other treatment-emergent adverse events (TEAEs)
ORR based on Independent Review Committee (IRC) assessment per Lugano criteria
| Arm | Type | Description |
|---|---|---|
| Rondecabtagene autoleucel | EXPERIMENTAL | - |
| Investigator's Choice CD19 | ACTIVE_COMPARATOR | axicabtagene ciloleucel, lisocabtagene maraleucel |
| Ph1, 3rd or later line, 3L+ have not received prior CAR T (Cohort 1) | EXPERIMENTAL | - |
| Ph1 CAR T experienced, 3L+ received at least two or more prior lines of treatment (Cohort 2) | EXPERIMENTAL | - |
| Ph1, 2L Refractory/relapse within 1 year of 1st-line therapy & no prior CAR T (Cohort 3) | EXPERIMENTAL | - |
| Ph1 (T-cell engager experienced, 3L+) received at least 2 prior lines including 1 TCE (Cohort 4) | EXPERIMENTAL | - |
| Ph1 high risk 1st line, PET-positive after 2-3 cycles chemoimmunotherapy, no prior CAR T (Cohort 5) | EXPERIMENTAL | - |
| Ph2, 3rd or later line, have not received prior CAR T (Cohort 1) | EXPERIMENTAL | Single dose determined during Phase 1. |
| Name | Type | Description |
|---|---|---|
| rondecabtagene autoleucel | BIOLOGICAL | An autologous, dual-targeting CD19/20 CAR T-cell candidate. |
| axicabtagene ciloleucel | BIOLOGICAL | An autologous CD19 CAR T-cell therapy |
| lisocabtagene maraleucel | BIOLOGICAL | An autologous CD19 CAR T-cell therapy |
| Rondecabtagene autoleucel (ronde-cel) | DRUG | CAR T-cell therapy |
| Fludarabine | DRUG | Conditioning chemotherapy |
| Cyclophosphamide | DRUG | Conditioning chemotherapy |
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) * Trans...
Rondecabtagene autoleucel is an investigational CAR-T cell therapy being developed by Lyell Immunopharma for large B-cell lymphoma and relapsed or refractory non-Hodgkin lymphoma. It is a CD19-directed autologous cell therapy currently in Phase 3 clinical development.
Rondecabtagene autoleucel is being studied for large B-cell lymphoma and relapsed or refractory non-Hodgkin lymphoma, including diffuse large B-cell lymphoma. It is an investigational therapy and has not been approved for commercial use; it is being evaluated in clinical trials in adults 18 years and older.
Rondecabtagene autoleucel targets CD19, a surface antigen expressed on B cells. It is an autologous CAR-T cell therapy, meaning a patient's own T cells are engineered to recognize and attack CD19-positive B-cell lymphoma cells.
Rondecabtagene autoleucel is being developed by Lyell Immunopharma, Inc., which trades on the Nasdaq under the ticker LYEL. Lyell is sponsoring the clinical program evaluating the therapy in B-cell lymphoma.
Rondecabtagene autoleucel is in Phase 3 clinical development. The Phase 3 trial is actively recruiting, and a Phase 1 study in aggressive large B-cell lymphoma is also ongoing. The therapy remains investigational and has not been approved by the FDA.
Rondecabtagene autoleucel is being evaluated in two recruiting studies. NCT07188558 is a Phase 3 trial comparing ronde-cel with investigator's choice CD19 CAR T-cell therapy, enrolling about 400 patients in the United States. NCT05826535 is a Phase 1 study in aggressive large B-cell lymphoma enrolling about 270 patients in the United States and Australia.
Yes, ronde-cel is the shorthand name for rondecabtagene autoleucel. Both names refer to the same CD19-directed CAR-T cell therapy developed by Lyell Immunopharma for large B-cell lymphoma and relapsed or refractory non-Hodgkin lymphoma.