Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Launched by KITE, A GILEAD COMPANY · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called KTE-X19 to see how safe and effective it is for adult Japanese patients with specific types of blood cancers: relapsed or refractory Mantle Cell Lymphoma (MCL) and B-precursor Acute Lymphoblastic Leukemia (B-ALL). The trial aims to find out how well KTE-X19 works in helping patients respond to treatment and achieve complete remission, which means no signs of the disease after treatment.

To be eligible for this study, participants with MCL need to have a confirmed diagnosis and have tried at least a few previous treatments without success. Those with B-ALL must have experienced a relapse or resistance to treatment after one or more therapies. Participants will receive KTE-X19 and will be monitored closely for their response to the treatment and any side effects. It's important to know that this trial is currently recruiting participants, and people interested in joining should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

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.