Relapsed or Refractory Lymphoma Including ENKL
Conditions
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
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).
Interventions
DRUGBrincidofovir
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).
Sponsors
SymBio Pharmaceuticals
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China, Japan, Singapore
Outcome results
None listed