Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KITE-753 · 1 trial · 1 indication
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...
KITE-753 is an investigational small molecule being studied for the treatment of relapsed or refractory large B-cell lymphoma. It is currently in Phase 3 clinical development for this indication, specifically in patients who have not responded to or have relapsed after first-line therapy.
KITE-753 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 3 clinical trial to evaluate the drug's efficacy in patients with relapsed or refractory large B-cell lymphoma.
KITE-753 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to evaluate its efficacy compared to an existing treatment for relapsed or refractory large B-cell lymphoma.
KITE-753 is being studied in a single Phase 3 clinical trial with the identifier NCT07479797. This randomized, controlled trial is comparing KITE-753 against axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma after first-line therapy. The trial is recruiting 550 participants across the United States, Australia, and Canada.
No, KITE-753 is not the same as axicabtagene ciloleucel. KITE-753 is a small molecule, while axicabtagene ciloleucel is a CAR T-cell therapy. The two are being compared directly in a Phase 3 clinical trial to evaluate which is more effective in treating relapsed or refractory large B-cell lymphoma after first-line therapy.