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)

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061240096

Enrollment

Registered

2024-12-24

Start date

2025-06-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory lymphoma including ENKL

Interventions

Phase 1b part: - The BCV dose will be escalated using the 3+3 design, evaluate the DLTs of BCV in each cohort (intravenous infusion of any of the doses in cohorts 1-3, twice a week), and investigate

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
- (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.)	—

Measure

Time frame

- (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.)

—

Countries

Hong Kong, Japan, Korea, Singapore

Contacts

Public ContactContact for Clinical Tiral information

SymBio Pharmaceuticals Limited

DL-ClinicalTrials_SyB@symbiopharma.com+81-3-5472-1127

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026