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 - JKART-1

Asou Hiroya0 sites21 target enrollmentJanuary 30, 2024

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2024

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Asou Hiroya

•\- Pathologically confirmed MCL with documentation or 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 chemotherapy, and
•\- Anti\-CD20 monoclonal antibody therapy, and
•\- Bruton's tyrosine kinase inhibitor (BTKi)
•\- Relapsed or refractory disease, defined by the following:
•\- Disease progression after last regimen, or
•\- Refractory disease is defined failure to achieve partial response (PR) or complete response (CR) to the last regimen
•\- At lease 1 measurable lesion
•\- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

•\- Autologous stem cell transplant (autoSCT) within 6 weeks of planned KTE\-X19 infusion
•\- History of allogenic stem cell transplant (alloSCT) with the exception of subjects with no donor cells detected on chimerism \> 100 days after alloSCT
•\- Prior CD19 targeted therapy
•\- Prior CAR therapy or other genetically modified T\-cell therapy
•\- Subjects with detectable cerebraospinal fluid (CSF) malignant cells or brain metastases or with a history of Central Nervous System (CNS) lymphoma, CSF malignant cells, or brain metastases
•\- CNS abnormalities
•\- Presence of CNS\-2 or CNS\-3 disease (those with CNS\-1 or CNS\-2 without clinically evident neurological changes are eligible to participate in the study)
•\- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement, posterior reversible encephalopathy syndrome, or cerebral edema within the last 2 years
•\- Presence of CNS\-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with \>\= 5 WBCs per mm3 with or without neurological changes, and
•\- Presence of CNS\-2 disease defined as detectable cerebrospinal blast cells in a sample of CSF with \<5 WBCs per mm3 with neurological changes