Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
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Keep this study
Lead
Kite, A Gilead Company
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
