Study of KTE-X19 in Adult Japanese Subjects with Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
- Conditions
- Relapsed/Refractory (r/r) Mantle Cell Lymphoma or r/r B-precursor Acute Lymphoblastic Leukemia
- Registration Number
- JPRN-jRCT2063230095
- Lead Sponsor
- Asou Hiroya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 21
- 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
- Relapsed or refractory B-ALL defined as one of the following:
- Relapsed or refractory disease after one line of systemic therapy:
- Primary refractory, or
- First relapse if first remission <=12 months
- Relapsed or refractory disease after two or more lines of systemic therapy
- Relapsed or refractory disease after allogenic transplant
- Morphological disease in the bone marrow (> 5% blasts)
- Subjects with Ph+ disease are eligible if they are intoleratnt to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/ refractory disease despite treatment with at least 2 different TKIs
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- In subjects previously treated with blinatumab, CD19 tumor expression on blasts obtained from bone marrow or peripheral blood is documented after completion of the most recent prior line of therapy
- 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
- History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, or cerebral edema within the last 2 years
- Those with the below prior medications:
- Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to enrollment
- Prior CD19 directed therapy other than blinatumomab
- History of Grade 4 neurologic event or Grade 4 CRS {Lee 2019} with prior CD19-directed therapy
- Any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment
- Acute graft versus host disease (GVHD) Grade II-IV by Glucksberg criteria or severity B-D by IBMTR index; acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method