Study Stopped
Due to challenges in recruiting eligible patients under the protocol.
A Phase 1b/2 Study of Intravenous Brincidofovir in Patients With Relapsed or Refractory Lymphoma and Relapsed or Refractory Extranodal Natural Killer/T-cell Lymphoma
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
1 other identifier
interventional
43
3 countries
8
Brief Summary
This study is a multi-center, global, open-label, Phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including Japan, Korea, and Singapore, to reveal the safety, tolerability, dose limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), pharmacokinetics (PK), and preliminary efficacy of BCV in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL). This study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (Phase 1b part: Up to 18 participants \[3 to 6 participants in each of the 3 cohorts\], Phase 2 part: 25 participants).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2025
Longer than P75 for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2024
CompletedFirst Posted
Study publicly available on registry
January 7, 2025
CompletedStudy Start
First participant enrolled
June 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 8, 2029
February 5, 2026
February 1, 2026
2.4 years
December 24, 2024
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase 1b part (Dose Escalation Part)
Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs
28 days
Phase 2 part (Expansion Part)
Best Overall Response as of end of treatment
7 months
Study Arms (1)
Brincidofovir twice weekly (BIW) via intravenous infusion
EXPERIMENTALInterventions
Phase 1b part is dose escalation study evaluating three dose levels of BCV, and participants will be assigned to a dose schedule in the order of study entry. In Phase 2 part, participants will receive BCV BIW at the RP2D (determined in the Phase 1b part).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with another active malignant tumor requiring treatment
- Patients with 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 Cidofovir intolerance
- Patients with a history of being diagnosed with cirrhosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Queen Mary Hospital
Hong Kong, China
Tokyo Metropolitan Komagome Hospital
Bunkyō City, Japan
National Cancer Center Hospital
Chūōku, Japan
Cancer Institute Hospital Of JFCR
Kōtoku, Japan
Kyoto University Hospital
Kyoto, Japan
Okayama University Hospital
Okayama, Japan
Mie University Hospital
Tsu, Japan
National Cancer Centre Singapore
Singapore, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2024
First Posted
January 7, 2025
Study Start
June 9, 2025
Primary Completion (Estimated)
October 23, 2027
Study Completion (Estimated)
May 8, 2029
Last Updated
February 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share