Active, not recruiting
Phase 2
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Condition(s) studied
Relapsed/Refractory Mantle Cell LymphomaRelapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Investigational drug(s) / intervention(s)
KTE-X19: A single infusion of chimeric antigen receptor (CAR) T cells
Cyclophosphamide: Administered intravenously
Fludarabine: Administered intravenously
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
Eligibility
Key Inclusion Criteria:
MCL Cohort:
* Pathologically confirmed MCL, with documentation of 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 remission (CR) to the last regimen
* At least 1 measurable lesion. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
* If the only measurable disease is lymph node disease, at least 1 lymph node should be ≥ 2 cm
ALL Cohort:
* 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 allogeneic transplant provided individuals is at least 100 days from SCT at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
* Morphological disease in the bone marrow (\> 5% blasts)
* Individuals with Philadelphia-positive (Ph+) disease are eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
Key Exclusion Criteria:
MCL Cohort:
* History of malignancy other than nonmelanomatous skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease-free for at least 3 years
* Autologous SCT (autoSCT) within 6 weeks of planned KTE-X19 infusion
* History of alloSCT with the exception of individuals 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
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19
ALL Cohort:
* Diagnosis of Burkitt's leukemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukemia lymphoid blast crisis
* History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
* History of hypersensitivity to any of the ingredients of KTE-X19 or to any of the animal-derived ingredients (bovine and rodent) used in the manufacturing process of KTE-X19
Note: Other protocols defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
- MCL Cohort: Objective Response Rate (ORR) Per Investigator Assessment — Up to 24 months
ORR is defined as the incidence of a complete remission (CR) or a partial remission (PR) per the Lugano Classification.
- ALL Cohort: Overall Complete Remission (OCR) Rate — Up to 24 months
OCR rate is defined as the percentage of participants achieving CR/complete remission with incomplete hematologic recovery (CRi) per investigator assessment.
Trial sites (9)
| Facility | City | Region | Status |
| 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 |
|
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