臨床研究等提出・公開システム

Japanese

Date of registration	May. 11, 2021
Last modified on	July. 21, 2023
Trial ID	jRCT2013210008

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

Contact for Scientific Queries	Name	Aso Hiroya
	Affiliation	Gilead Sciences, K.K.
	Address	1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-6837-0710
	E-mail	ClinicalTrialGSJ@gilead.com
Contact for Public Queries	Name	Clinical Operations
	Affiliation	Gilead Sciences, K.K.
	Address	1-9-2, Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-6837-0710
	E-mail	JPClinicalOperations@gilead.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 01, 2021
Actual date of first enrollment		May. 29, 2023
Target sample size		00
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion Criteria	Patients for whom the principal investigator or the subinvestigator judged that participation in the clinical trial was inappropriate.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		DLBCL, PMBCL, TFL, HGBCL
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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		To evaluate safety of non-standard commercial products based on adverse events.
Secondary Outcome(s)		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.

Primary Sponsor	Gilead Sciences K.K.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
Telephone	+81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 21, 2023	(this page)	Changes
3	June. 20, 2023	Detail	Changes
2	May. 19, 2022	Detail	Changes
1	May. 11, 2021	Detail

List of change history