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

NCT06761677 — Phase 1 / Phase 2, Suspended, 43 participants, SymBio Pharmaceuticals

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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

Registry	NCT06761677
Status	Suspended - Due to challenges in recruiting eligible patients under the protocol.
Phase	Phase 1 / Phase 2
Study type	Interventional; na, sequential, masking: none, treatment
Enrollment	43 (Estimated)
Sponsor	SymBio Pharmaceuticals (Industry)
Conditions	Relapsed or Refractory Lymphoma Including ENKL
Interventions	Brincidofovir (Drug)
Dates	start 2025-06-09, primary completion 2027-10-23 (estimated), completion 2029-05-08 (estimated), first posted 2025-01-07, last updated 2026-02-05
Locations	8 sites in China, Japan, Singapore

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
Brincidofovir twice weekly (BIW) via intravenous infusion	Experimental	Drug: Brincidofovir

Brincidofovir (Drug), also known as SyB V-1901, BCV: 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).

+Outcome measures

Primary outcomes

Phase 1b part (Dose Escalation Part) [28 days]: Adverse events (AEs) that meet the protocol-defined DLT criteria in Cycle 1 and the number of participants that developed these AEs
Phase 2 part (Expansion Part) [7 months]: Best Overall Response as of end of treatment

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (8)

Facility	City	Country
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