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

Last updated: March 24, 2025
Sponsor: SymBio Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Treatment

Brincidofovir

Clinical Study ID

NCT06761677
BCV-NL01
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are histopathologically diagnosed with ENKL based on the World HealthOrganization (WHO) Classification of Malignant Lymphoma 5th Edition (WHO-HAEM5) (canbe enrolled in the Phase 1b part and the Phase 2 part) or patients diagnosed withEBV-positive nodal T- and NK-cell lymphoma (EBV + nTNKCL), nodal T-follicular helpercell lymphoma (nTFHcL) (including angioimmunoblastic T-cell lymphoma (AITL) asdefined in the WHO Classification, 4th Edition), peripheral T-cell lymphoma nototherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), diffuselarge 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 systemicchemotherapy (history of multidrug chemotherapy including L-asparaginase such asSMILE therapy for ENKL is mandatory) who are ineligible for other systemic therapies

  • Patients with the following Eastern Cooperative Oncology Group (ECOG) PerformanceStatus (PS):

  • Phase 1b part: 0-1

  • Phase 2 part: 0-2

Exclusion

Exclusion Criteria:

  • Patients with another active malignant tumor requiring treatment

  • Patients with NCI-CTCAE Grade 2 or higher diarrhea (increase of 4 or more bowelmovements per day compared to usual number of bowel movements) within 7 days priorto 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

Study Design

Total Participants: 43
Treatment Group(s): 1
Primary Treatment: Brincidofovir
Phase: 1/2
Study Start date:
March 31, 2025
Estimated Completion Date:
May 08, 2029

Connect with a study center

  • National Cancer Center Hospital

    Chuo-ku,
    Japan

    Active - Recruiting

  • Cancer Institute Hospital Of JFCR

    Koto-ku,
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu,
    Japan

    Active - Recruiting

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