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This is a single-arm, open-label phase 2 study to evaluate the safety and efficacy of single agent balstilimab in participants with relapsed/refractory lymphoma. The study will enroll participants with relapsed/refractory classical Hodgkin lymphoma or primary mediastinal B-cell lymphoma. The participants will receive balstilimab (BAL) 300 mg IV every 3 weeks. BAL infusions will be administered within 30 minutes (± 5 min) using an infusion pump.
The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods:
Screening Period: approximately 28 days
Treatment Period: up to 24 months, or until any criterion for stopping the study drug or withdrawal from the study occurs
Follow-up Period: up to 24 months from last dose of study treatment for every patient who is alive
Study Duration
- Recruitment: 2 years
- Treatment: 2 years
- Follow-up: 2 years
Sponsor: Immune Oncology Research Institute
Collaborators: Agenus Inc.
Study Director: Gevorg Tamamyan, MD, PhD, DSc, Immune Oncology Research Institute
Study Chair: Samvel Bardakhchyan, MD, PhD, Immune Oncology Research Institute
Principal Investigator: Astghik Voskanyan, MD, Hematology Center named after Prof. R. Yeolyan
More information can be found at
Study Details | Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001) | ClinicalTrials.gov
About IMMONC
Immune Oncology Research Institute (IMMONC) is dedicated to advancing research aimed at preventing, treating, and ultimately curing cancer while making these innovations accessible to those who need them. If you're interested in joining our team, please feel free to contact us at [email protected] or at +374-41 310-048.