臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 31, 2022
Last modified on	June. 05, 2025
Trial ID	jRCT2013210066

Scientific Title	Phase I/II, open label, multicenter study of rapcabtagene autoleucel in adult patients with CLL/SLL, 3L+ DLBCL, ALL and 1L HR LBCL
Public Title	Phase I/II study of rapcabtagene autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL

Contact for Scientific Queries	Name	Yamauchi Kyosuke
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com
Contact for Public Queries	Name	Yamauchi Kyosuke
	Affiliation	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Telephone	+81-120-003-293
	E-mail	rinshoshiken.toroku2@novartis.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 18, 2022
Actual date of first enrollment		Jan. 18, 2022
Target sample size		11
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	- ECOG performance status 0-1 - DLBCL diagnosis by local histopathology - DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT) - Refractory or relapsed CD19-positive ALL - ALL with morphologic disease in the bone marrow - 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis: - IPI score of 3, 4 or 5 - MYC and BCL2 and/or BCL6 rearrangement (DH/THL)
	Exclusion Criteria	- Prior CD19-directed therapy - Prior administration of a genetically engineered cellular product - Prior allogeneic HSCT - Richter's transformation - Active CNS lymphoma - Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		DLBCL, ALL, CLL
Intervention(s)		DLBCL, ALL : Single infusion of YTB323 CLL : Single infusion of YTB323 and daily ibrutinib
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		1. Dose recommendation: incidence and nature of Dose Limiting Toxicities (Dose Escalation part only) [ Time Frame: 24 months ] 2. Safety: incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs [ Time Frame: 24 months ] 3. Tolerability: ibrutinib dose modifications in the CLL/SLL arm [ Time Frame: 24 months ] 4. Manufacture success: number of patients infused with planned target dose [ Time Frame: 24 months ] 5. Phase 2: Complete Response Rate (CRR) as assessed by local Investigator [ Time Frame: 24 months ] CRR defined as best overall response (BOR) of CR after rapcabtagene autoleucel infusion as per Lugano criteria for 3L+ Diffuse Large B-Cell Lymphoma (DLBCL) and 1L High Risk Large B-Cell (HR LBCL)
Secondary Outcome(s)

Primary Sponsor	Novartis Pharma. 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	Kita14, Nishi5, Kita-ku, Sapporo, Hokkaido 060-8648, Japan, Hokkaido
Telephone
E-Mail
Approval Status	Approval
Date of approval	July. 20, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT03960840
Issuing Authority	Clinical Traials.gov

Countries of Recruitment（Except Japan）	United States/Australia/Austria/France/Italy/Spain

History of Changes

No	Publication date
3	June. 05, 2025	(this page)	Changes
2	Sept. 29, 2023	Detail	Changes
1	Jan. 31, 2022	Detail

List of change history