Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KTE-X19 · 1 trial · 2 indications
ORR is defined as the incidence of a complete remission (CR) or a partial remission (PR) per the Lugano Classification.
OCR rate is defined as the percentage of participants achieving CR/complete remission with incomplete hematologic recovery (CRi) per investigator assessment.
| Arm | Type | Description |
|---|---|---|
| MCL Cohort- KTE-X19 | EXPERIMENTAL | Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by KTE-X19 administered intravenously at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of 2 x 10\^8 anti-CD19 CAR T cells will be administered. |
| ALL Cohort- KTE-X19 | EXPERIMENTAL | Participants will receive cyclophosphamide 900 mg/m\^2/day intravenously (IV) for 1 day and fludarabine 25 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by KTE-X19 administered intravenously at a target dose of 1 x 10\^6 19 CAR T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of 1 x 10\^8 anti-CD19 CAR T cells will be administered. |
| Name | Type | Description |
|---|---|---|
| KTE-X19 | DRUG | A single infusion of chimeric antigen receptor (CAR) T cells |
| Cyclophosphamide | DRUG | Administered intravenously |
| Fludarabine | DRUG | Administered intravenously |
Key Inclusion Criteria: MCL Cohort: * Pathologically confirmed MCL, with documentation of either overexpression of cyclin D1 or presence of t(11;14) * Up to 5 prior regimens for MCL. Prior therapy must have included: * Anthracycline-, bendamustine-, or high-dose cytarabine- containing chemother...
KTE-X19 is an investigational therapy being studied for relapsed/refractory mantle cell lymphoma and relapsed/refractory B-precursor acute lymphoblastic leukemia. It is currently in Phase 2 clinical development for these indications.
KTE-X19 is being developed by Gilead Sciences, Inc., which trades on the NASDAQ under the ticker GILD. The company is conducting clinical trials of KTE-X19 in oncology.
KTE-X19 is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. It is being studied in an active but not recruiting clinical trial.
KTE-X19 is being studied in clinical trial NCT06253663, a Phase 2 study in adult Japanese participants with relapsed/refractory mantle cell lymphoma or relapsed/refractory B-precursor acute lymphoblastic leukemia. The trial is active but not recruiting and has an enrollment of 25 participants.
Yes, KTE-X19 is being studied in Japan. The Phase 2 clinical trial NCT06253663 enrolls adult Japanese participants aged 18 years and older with relapsed/refractory mantle cell lymphoma or relapsed/refractory B-precursor acute lymphoblastic leukemia.