臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 24, 2024
Last modified on	Dec. 24, 2024
Trial ID	jRCT2061240096

Scientific Title	A Multi-Center, Global, Open-Label, Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma As Well As to Evaluate the Safety and Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma Using The Recommended Phase 2 Dose (BCV-NL01)
Public Title	A Phase 1b/2 Study of IV Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma (BCV-NL01)

Scientific Title

A Multi-Center, Global, Open-Label, Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma As Well As to Evaluate the Safety and Efficacy of Intravenous Brincidofovir in Patients With Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma Using The Recommended Phase 2 Dose (BCV-NL01)

Public Title

A Phase 1b/2 Study of IV Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma (BCV-NL01)

Contact for Scientific Queries	Name	Tobinai Kensei
	Affiliation	National Cancer Center Hospital
	Address	4-1-28 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-5472-1127
	E-mail	DL-ClinicalTrials_SyB@symbiopharma.com
Contact for Public Queries	Name	Contact for Clinical Tiral information
	Affiliation	SymBio Pharmaceuticals Limited
	Address	4-1-28 Toranomon, Minato-ku, Tokyo
	Telephone	+81-3-5472-1127
	E-mail	DL-ClinicalTrials_SyB@symbiopharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 20, 2024
Actual date of first enrollment
Target sample size		43
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	dose comparison control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients who are histopathologically diagnosed with ENKL based on the World Health Organization (WHO) Classification of Malignant Lymphoma 5th Edition (WHO-HAEM5) (can be enrolled in the Phase 1b part and the Phase 2 part) or patients diagnosed with EBV-positive nodal T- and NK-cell lymphoma (EBV + nTNKCL), nodal T-follicular helper cell lymphoma (nTFHcL) (including angioimmunoblastic T-cell lymphoma (AITL) as defined in the WHO Classification, 4th Edition), peripheral T-cell lymphoma not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), diffuse large B-cell lymphoma (DLBCL) (e.g., DLBCL, NOS), or adult T-Cell Leukemia Lymphoma (ATLL) (can only be enrolled in the Phase 1b part) - Patients with relapsed or refractory lymphoma and previously treated with systemic chemotherapy (history of multidrug chemotherapy including L-asparaginase such as SMILE therapy for ENKL is mandatory) who are ineligible for other systemic therapies - Patients with the following Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): - Phase 1b part: 0-1 - Phase 2 part: 0-2
	Exclusion Criteria	- Patients with another active malignant tumor requiring treatment - Patients with National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2 or higher diarrhea (increase of 4 or more bowel movements per day compared to usual number of bowel movements) within 7 days prior to starting the first dose of BCV - Graft-Versus-Host Disease (GVHD) patients requiring immunosuppressive agents - Patients with a history of CDV intolerance - Patients with a history of being diagnosed with cirrhosis
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Relapsed or refractory lymphoma including ENKL
Intervention(s)		Phase 1b part: - The BCV dose will be escalated using the 3+3 design, evaluate the DLTs of BCV in groups of 3 participants in each cohort (intravenous infusion of any of the doses in cohorts 1-3, twice a week), and investigate the recommended dosage and administration prior to the start of the Phase 2 part. Phase 2 part: - BCV RP2D determined in the Phase Ib part will be administered via intravenous infusion twice weekly.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		- (Phase 1b Part only) Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs - Incidence of treatment-emergent adverse events (TEAEs) after initiation of BCV treatment (particularly the incidence of AEs and serious adverse events [SAE] of NCI-CTCAE Grade 3 or higher) - (Phase 2 Part only) Best Overall Response as of end of treatment (EOT) - PK exposure dose by participants estimated using population PK analysis (maximum plasma concentration [Cmax] and the area under the concentration-time curve [AUC], etc.)
Secondary Outcome(s)

Primary Sponsor	SymBio Pharmaceuticals Limited

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	IRB of Okayama University Hospital
Address	2-5-1, Shikata-cho, Kita-ku, Okayama-city, Okayama, Okayama
Telephone	+81-86-235-7534
E-Mail	chiken@okayama-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 19, 2024

Name of Certified Review Board	Institutional Review Board, Mie University Hospital
Address	2-174 Edobashi, Tsu, Mie, Okayama
Telephone	+81-59-231-5246
E-Mail	chiken-jk@med.mie-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 19, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	Korea/Singapore/Hong Kong