臨床研究等提出・公開システム

Japanese

Date of registration	June. 03, 2024
Last modified on	June. 03, 2024
Trial ID	jRCT1030240137

Scientific Title	Elucidation of the kinetics and mechanism of action of EPHB4-CAR-T cells in the human body:Phase I study of non-viral gene-modified CAR-T cell therapy for malignant solid tumors with expression of EPHB4 receptor (Elucidation of the kinetics and mechanism of action of EPHB4-CAR-T cells in the human body:Phase I study of non-viral gene-modified CAR-T cell therapy for malignant solid tumors with expression of EPHB4 receptor)
Public Title	Translational research:CARTiEr study (Translational research:CARTiEr study)

Scientific Title

Elucidation of the kinetics and mechanism of action of EPHB4-CAR-T cells in the human body:Phase I study of non-viral gene-modified CAR-T cell therapy for malignant solid tumors with expression of EPHB4 receptor (Elucidation of the kinetics and mechanism of action of EPHB4-CAR-T cells in the human body:Phase I study of non-viral gene-modified CAR-T cell therapy for malignant solid tumors with expression of EPHB4 receptor)

Public Title

Translational research:CARTiEr study (Translational research:CARTiEr study)

Contact for Scientific Queries	Name	Nakatsura Testuya
	Affiliation	National Cancer Center Hospital
	Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
	Telephone	+81-4-7133-1111
	E-mail	cartier_core@east.ncc.go.jp
Contact for Public Queries	Name	Suzuki Toshihiro
	Affiliation	National Cancer Center Hospital
	Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
	Telephone	+81-4-7133-1111
	E-mail	cartier_core@east.ncc.go.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 03, 2024
Target sample size		18
Study Type		Observational
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 enrolled in CARTiEr study 2.Written consent has been obtained from the patient for this ancillary study.
	Exclusion Criteria	1.Written consent has not been obtained from the patient for this ancillary study. 2.Patients who are regarded as inappropriate for enrollment by investigators.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Ewing's sarcoma or solid tumors diagnosed as advanced relapsed with no standard treatment or refract
Primary Outcome(s)		Incidence of Secondary Cancer Incidence of delayed toxicity
Secondary Outcome(s)		Overall survival:OS CAR gene copy number CAR-positive cells number in peripheral blood Phenotypic Analysis TCR Repatoir Analysis Plasma protein measurement scRNA sequencing analysis Immunostaining of tumor specimens CAR gene expression analysis and immunostaining of secondary cancer specimens Functional analysis of CAR-T cells

Primary Sponsor	National Cancer Center Hospital

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan, Tokyo, Tokyo
Telephone	+81-3-3542-2511
E-Mail	NCC_IRBoffice@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	Oct. 03, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none