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

JRCT ID: jRCT2013210008

Registered date:11/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: DLBCL, PMBCL, TFL, HGBCL
• Date of first enrollment: 29/05/2023
• Target sample size: 00
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: To evaluate safety of non-standard commercial products based on adverse events.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

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

Related Information

• Primary Sponsor: Aso Hiroya