NCT06253663

A Phase 2 Multicenter Study Evaluating the Safety and the Efficacy of KTE-X19 in Adult Japanese Subjects With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Study Summary

The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL). The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by: * Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL * Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL

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Interventions

KTE-X19DRUG
A single infusion of chimeric antigen receptor (CAR) T cells
CyclophosphamideDRUG
Administered intravenously
FludarabineDRUG
Administered intravenously

Study Locations

FacilityCityStateCountry
Chiba University HospitalChibaJapan
Kyushu University HospitalFukuokaJapan
Hokkaido University HospitalHokkaidoJapan
Kyoto University HospitalKyotoJapan
Tohoku University HospitalMiyagiJapan
Okayama University HospitalOkayamaJapan
National Cancer Center HospitalTokyoJapan
Juntendo University HospitalTokyoJapan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome HospitalTokyoJapan

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026