Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KTE-C19 · 1 trial · 1 indication
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...
KTE-C19 is an investigational monoclonal antibody being studied for the treatment of refractory Diffuse Large B Cell Lymphoma (DLBCL). It is being evaluated in combination with atezolizumab in adult patients with this condition. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
KTE-C19 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential role in treating refractory Diffuse Large B Cell Lymphoma, though the precise mechanism of action remains unspecified in public data.
KTE-C19 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy in patients with refractory Diffuse Large B Cell Lymphoma.
KTE-C19 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not received FDA approval and is still undergoing clinical trials to assess its safety and efficacy. The drug is being studied for the treatment of refractory Diffuse Large B Cell Lymphoma.
KTE-C19 has one completed clinical trial registered under NCT02926833, titled 'Study of Safety and Efficacy of KTE-C19 in Combination With Atezolizumab in Adults With Refractory Diffuse Large B-Cell Lymphoma (DLBCL)'. This Phase 1 study enrolled 37 participants in the United States and included adult patients aged 18 years and older.