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A phase3b study of KTE-C19 (at the time of manufacture of commercially available products) in patients with the indication on the package insert

A phase3b study of KTE-C19 (at the time of manufacture of commercially available products) in patients with the indication on the package insert

1

One participant was enrolled, leukapheresed, received lymphodepleting chemotherapy, and dosed with OOS axicabtagene ciloleucel.

One participant was enrolled, leukapheresed, received lymphodepleting chemotherapy, and dosed with OOS axicabtagene ciloleucel. The participant died on Day 205 due to progressive disease (PD) related to the primary malignancy.

The participant experienced a Grade 1 neurologic event (delirium) that was determined to be unrelated to OOS axicabtagene ciloleucel. The event started on Day 80 and resolved on Day 89. The participant had 24 events of Grade 3 or higher cytopenias, including a Grade 4 event of serious neutrophil count decreased that started on Day 0 and was ongoing at the time of death, and a Grade 3 event of serious febrile neutropenia that started on Day 46 and resolved on Day 101. Both events were deemed related to OOS axicabtagene ciloleucel. All other events of cytopenia were nonserious. The participant experienced Grade 1 CRS that was deemed related to OOS axicabtagene ciloleucel. The event started on Day 0 and resolved on Day 7. The participant died on Day 205 after OOS axicabtagene ciloleucel infusion due to PD related to the primary malignancy.

Efficacy assessments were not collected or reported for this study.

The primary objective of this study was to evaluate the safety of OOS axicabtagene ciloleucel.The 1 participant who was enrolled and treated with OOS axi-cel experienced Grade 4 neutrophil count decreased, Grade 3 febrile neutropenia, Grade 2 tumor fever, Grade 1 CRS, and Grade 1 neurologic event. No new safety signals were reported in this study. The safety profile of OOS axicabtagene ciloleucel was consistent with that of commercially available products.

Jan. 31, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2013210008

Aso Hiroya

Gilead Sciences, K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

ClinicalTrialGSJ@gilead.com

Clinical Operations

Gilead Sciences, K.K.

1-9-2, Marunouchi, Chiyoda-ku, Tokyo

+81-3-6837-0710

JPClinicalOperations@gilead.com

Complete

July. 01, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1)Patients who have been identified and manufactured to meet the requirements for treatment with commercially available axicabtagene ciloleucel. The product does not conform to the commercial product specification and cannot be shipped as a commercial product. However, the product conforms to the clinical trial product specification and the sponsor determines that the product can be diverted to the clinical trial product.
2)Patients for whom the principal investigator or the subinvestigator has assessed the patient's condition and disease, and determined that they cannot wait for remanufacturing of the product that meets the commercially available specifications from the re-leukocyte apheresis or from the excess PBMC frozen at the manufacturing site.

Patients for whom the principal investigator or the subinvestigator judged that participation in the clinical trial was inappropriate.

Both

DLBCL, PMBCL, TFL, HGBCL

KTE-C19 will be administered to achieve target dose of anti-CD19 CAR T cells 2.0 X 10^6 cells/kg. For a subject weighing > 100 kg, KTE-C19 will be administered to achieve the maximum fixed dose of 2.0 X 10^8 cells.

To evaluate safety of non-standard commercial products based on adverse events.

To evaluate efficacy of the indication in the package insert based on objective response rate (ORR) and overall survival (OS) in patients with the indication on the package insert. To evaluate pharmacokinetics in vivo of KTE-C19.

+81-11-706-7061

Jan. 19, 2021

none