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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07479797 | Study Evaluating the Efficacy of KITE-753 Versus Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma After First-Line Therapy | PHASE3 | RECRUITING | 550 | — | — | Aug 1, 2026 | May 1, 2031 | May 12, 2026 | 1 | United States |
Participants who would be in CR at Month 6 postinfusion of KITE-753 or axi-cel and prior to subsequent anti-lymphoma therapy. This will be assessed by the Lugano Classification by the blinded central assessment.
EFS is defined as the time from randomization to the earliest occurrence of the following EFS events: a) Death due to any cause, b) Disease progression/relapse per blinded central assessment, and c) Initiation of any non-protocol specified subsequent anti-lymphoma therapy for the treatment of residual disease (including stable disease and partial response as per International Working Group (IWG) Lugano Response Criteria for Malignant Lymphoma).
| Arm | Type | Description |
|---|---|---|
| Lymphodepleting Chemotherapy: KITE-753 | EXPERIMENTAL | Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-cluster of differentiation 19 (CD19)/CD20 chimeric antigen receptor (CAR) T cells/kg of KITE-753. |
| Lymphodepleting Chemotherapy: Axicabtagene Ciloleucel (axi-cel) | EXPERIMENTAL | Participants with r/r LBCL will receive the following treatment during the study: * A conditioning chemotherapy regimen of fludarabine and cyclophosphamide. * A single infusion at a target dose of anti-CD19/CD20 CAR T cells/kg of axi-cel. |
| Name | Type | Description |
|---|---|---|
| KITE-753 | DRUG | A single infusion of CAR-transduced autologous T cells administered as intravenous infusion. |
| Axicabtagene Ciloleucel | DRUG | A single infusion of CAR-transduced autologous T cells administered as intravenous infusion. |
| Fludarabine | DRUG | Administered intravenously |
| Cyclophosphamide | DRUG | Administered intravenously |
Key Inclusion Criteria: * Individuals with any of the following large B-cell lymphomas, as determined by the investigator, are eligible for the study as defined below: * World Health Organization (WHO): * Individuals with chemorefractory disease to first-line therapy (primary refractory dis...