drugset / Trial / NCT06253663
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2024-03-18
- Primary completion
- 2027-07
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexucabtagene Autoleucel | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | Brexucabtagene Autoleucel | Cell therapy | 2e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 900 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |