Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02926833 | Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL) | PHASE1 | COMPLETED | 37 | — | — | Sep 29, 2016 | Jan 12, 2023 | Mar 6, 2024 | 5 | United States |
A DLT was defined as the following KTE-C19-related or ATZ-related events with an onset from immediately after the first ATZ infusion through 21 days after the first ATZ infusion: Grade 4 hematologic toxicity lasting \> 30 days (except lymphopenia or B-cell aplasia); All KTE-C19- or ATZ-related Grade 3 non-hematologic toxicities lasting for \> 7 days and all KTE-C19- or ATZ-related Grade 4 non-hematologic toxicities regardless of duration.
CRR was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) as assessed by the study investigators. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.
| Arm | Type | Description |
|---|---|---|
| Phase 1 Cohort 1: KTE-C19 + ATZ (After 21 Days of KTE-C19) | EXPERIMENTAL | Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide intravenous (IV) infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg followed by 4 doses of atezolizumab (ATZ) (1200 mg/dose) IV infusion every 21 days, beginning 21 days following KTE-C19. |
| Phase 1 Cohort 2: KTE-C19 + ATZ (After 14 Days of KTE-C19) | EXPERIMENTAL | Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 14 days following KTE-C19. |
| Phase 1 Cohort 3: KTE-C19 + ATZ (After 1 Day of KTE-C19) | EXPERIMENTAL | Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19. |
| Phase 2: KTE-C19 + ATZ (After 1 Day of KTE-C19) | EXPERIMENTAL | Participants received conditioning chemotherapy consisting of 30 mg/m\^2 fludarabine and 500 mg/m\^2 cyclophosphamide IV infusion per day for 3 days followed by KTE-C19 IV infusion at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg followed by 4 doses of ATZ (1200 mg/dose) IV infusion every 21 days, beginning 1 day following KTE-C19. |
| Name | Type | Description |
|---|---|---|
| KTE-C19 | BIOLOGICAL | A single infusion of KTE-C19 CAR-T cells administered intravenously |
| Atezolizumab | BIOLOGICAL | Administered intravenously |
| Cyclophosphamide | DRUG | Administered intravenously |
| Fludarabine | DRUG | Administered intravenously |
Key Inclusion Criteria: 1. Histologically confirmed DLBCL 2. Chemotherapy-refractory disease, defined as one or more of the following: * Stable disease (duration of stable disease must be less than or equal to 6 months) or progressive disease as best response to most recent chemotherapy contain...