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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

NCT ID: NCT06761677

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-09

Study Completion Date

2029-05-08

Brief Summary

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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).

Detailed Description

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Conditions

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Relapsed or Refractory Lymphoma Including ENKL

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brincidofovir twice weekly (BIW) via intravenous infusion

Group Type EXPERIMENTAL

Brincidofovir

Intervention Type DRUG

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).

Interventions

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Brincidofovir

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).

Intervention Type DRUG

Other Intervention Names

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SyB V-1901 BCV

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SymBio Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Queen Mary Hospital

Hong Kong, , China

Site Status

Tokyo Metropolitan Komagome Hospital

Bunkyō City, , Japan

Site Status

National Cancer Center Hospital

Chūōku, , Japan

Site Status

Cancer Institute Hospital Of JFCR

Kōtoku, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

Mie University Hospital

Tsu, , Japan

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Countries

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China Japan Singapore

Other Identifiers

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BCV-NL01

Identifier Type: -

Identifier Source: org_study_id