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
After completing at least 24 months in the study, all participants who received an infusion of KTE-X19 will be transitioned to a separate long-term follow-up (LTFU) study (KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
A single infusion of chimeric antigen receptor (CAR) T cells
Administered intravenously
Administered intravenously
Chiba University Hospital
Chiba, Japan
Kyushu University Hospital
Fukuoka, Japan
Hokkaido University Hospital
Hokkaido, Japan
Kyoto University Hospital
Kyoto, Japan
Tohoku University Hospital
Miyagi, Japan
Okayama University Hospital
Okayama, Japan
National Cancer Center Hospital
Tokyo, Japan
Juntendo University Hospital
Tokyo, Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Tokyo, Japan
MCL Cohort: Objective Response Rate (ORR) Per Investigator Assessment
ORR is defined as the incidence of a complete remission (CR) or a partial remission (PR) per the Lugano Classification.
Time frame: Up to 24 months
ALL Cohort: Overall Complete Remission (OCR) Rate
OCR rate is defined as the percentage of participants achieving CR/complete remission with incomplete hematologic recovery (CRi) per investigator assessment.
Time frame: Up to 24 months
MCL Cohort: Duration of Response (DOR)
DOR is defined as time from first objective response to disease progression per indication specific response criteria or death from any cause.
Time frame: Up to 24 months
MCL Cohort: Best Objective Response (BOR)
BOR is defined as the incidence of CR, PR, Stable disease (SD) or progressive disease (PD) or unevaluable as best response to treatment.
Time frame: Up to 24 months
MCL Cohort: Progression-Free Survival (PFS)
PFS is defined as time from enrollment or KTE-X19 infusion to disease progression per indication specific response criteria or death from any cause.
Time frame: Up to 24 months
MCL Cohort: Levels of Cytokines in Serum
Time frame: Up to Day 28
ALL Cohort: Minimal Residual Disease (MRD) Negativity Rate
The incidence of a minimal residual disease response (MRD-). MRD- is defined as MRD \< 10\^-6 per the standard assessment.
Time frame: Up to 24 months
ALL Cohort: Allogeneic Stem Cell Transplant (alloSCT) rate
The percentage of participants receiving alloSCT as the 1st next therapy after KTE-X19 infusion.
Time frame: Up to 24 months
ALL Cohort: Relapse-Free Survival (RFS)
RFS is defined as the time from enrollment or KTE-X19 infusion date to the date of disease relapse or death from any cause.
Time frame: Up to 24 months
ALL Cohorts: DOR
DOR is defined as the time between their first complete remission (CR or CRi) to relapse or any death in the absence of documented relapse.
Time frame: Up to 24 months
MCL and ALL Cohort: Levels of Anti-Cluster of Differentiation 19 (Anti-CD19) CAR T Cells in Blood
Time frame: Up to 24 months
MCL and ALL Cohorts: Percentages of Participants Experiencing Treatment-emergent Adverse Event (TEAEs), Serious Adverse Event (SAEs) and Deaths
Time frame: First infusion date up to 24 months
MCL and ALL Cohorts: Overall Survival (OS)
OS is defined as the time from enrollment or KTE-X19 infusion to death from any cause.
Time frame: Up to 24 months
MCL and ALL Cohorts: Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
Time frame: First infusion date up to 24 months
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