Clinical trial NCT06761677: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Refractory Lymphoma Including ENKL
Keywords: SyB V-1901
BCV
Relapsed or refractory Lymphoma
Extranodal Natural Killer/T-cell Lymphoma
ENKL
EBV-positive nodal T- and NK-cell lymphoma
EBV + nTNKCL
nodal T-follicular helper cell lymphoma
nTFHcL
angioimmunoblastic T-cell lymphoma
AITL
peripheral T-cell lymphoma not otherwise specified
PTCL-NOS
anaplastic large cell lymphoma
ALCL
diffuse large B-cell lymphoma
DLBC
DLBCL-NOS
adult T-Cell Leukemia Lymphoma
ATLL
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


Eligibility 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:

* 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

Primary outcomes:
measure: Phase 1b part (Dose Escalation Part)
timeFrame: 28 days
measure: Phase 2 part (Expansion Part)
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Bunkyō-Ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital Of JFCR
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
References: