Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...