Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JCAR017 2-dose schedule · 1 trial · 5 indications
Physiological parameter
Physiological parameter
Lugano criteria
| Arm | Type | Description |
|---|---|---|
| JCAR017 1-dose schedule | EXPERIMENTAL | Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 1 intravenous (IV) injection |
| JCAR017 2-dose schedule (no longer accruing) | EXPERIMENTAL | Each cycle of JCAR017 (lisocabtagene maraleucel) will be administered as 2 intravenous (IV) injections |
| Name | Type | Description |
|---|---|---|
| JCAR017 (lisocabtagene maraleucel) single-dose schedule | BIOLOGICAL | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection. |
| JCAR017 (lisocabtagene maraleucel) 2-dose schedule | BIOLOGICAL | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR017. |
Inclusion Criteria: 1. Age ≥18 years 2. Relapsed or refractory B-cell NHL, including 1. DLBCL cohort (no longer enrolling): DLBCL, not otherwise specified (NOS; includes transformed DLBCL from indolent histology \[tDLBCL\]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement...