Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Rondecabtagene autoleucel (ronde-cel)
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 (ronde-cel) is an investigational cell therapy being studied for the treatment of large B-cell lymphoma and relapsed or refractory non-Hodgkin lymphoma. It is currently in clinical development and has not been approved by the FDA.
Rondecabtagene autoleucel is being developed by Lyell Immunopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LYEL.
Rondecabtagene autoleucel is in Phase 1 clinical development. It is being studied in an early-stage trial for aggressive large B-cell lymphoma, and it remains an investigational product not yet approved for commercial use.
Rondecabtagene autoleucel is being evaluated in two clinical trials. NCT05826535 is a Phase 1 study in aggressive large B-cell lymphoma with 270 participants. NCT07188558 is a Phase 3 study comparing ronde-cel to investigator's choice CD19 CAR T-cell therapy in large B-cell lymphoma with 400 participants.
Yes, Rondecabtagene autoleucel is also known as ronde-cel. The shorter name ronde-cel is used in clinical trial titles and refers to the same investigational cell therapy being developed for large B-cell lymphoma and relapsed non-Hodgkin lymphoma.