臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 11, 2025
Last modified on	June. 06, 2025
Trial ID	jRCT2013240076

Scientific Title	A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) (CYTB323I12201)
Public Title	Phase 2 study evaluating rapcabtagene autoleucel in participants with severe active GPA or MPA (CYTB323I12201)

Contact for Scientific Queries	Name	Inoue Ayano
	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.toroku@novartis.com
Contact for Public Queries	Name	Inoue Ayano
	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.toroku@novartis.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 12, 2025
Actual date of first enrollment		Mar. 13, 2025
Target sample size		11
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Men and women, aged >=18 and =< 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria 2. Positive test for ANCA-autoantibodies 3. GPA and MPA participants with severe active disease
	Exclusion Criteria	1. Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study 2. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol 3. Other systemic autoimmune diseases requiring therapy 4. Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy 5. Inadequate organ function
	Age Minimum	18age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
Intervention(s)		Rapcabtagene autoleucel arm: Single infusion of rapcabtagene autoleucel Active Comparator arm: Active comparator option as per protocol
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Event-free survival
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	Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648, Japan, Hokkaido
Telephone	+81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Dec. 24, 2024

Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Plan to share IPD

Yes

Plan description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

Secondary ID(s)	NCT06868290
Issuing Authority	Clinical Trials.gov

Countries of Recruitment（Except Japan）	Singapore/United States

History of Changes

No	Publication date
2	June. 06, 2025	(this page)	Changes
1	Mar. 11, 2025	Detail

List of change history