study of kte-x19 in adult japanese participants with relapsed/refractory mantle cell lymphoma or relapsed/refractory b-precursor acute lymphoblastic leukemia

Conditions: Relapsed/Refractory Mantle Cell Lymphoma; Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

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

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.

Eligibility criteria:
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.