NCT05891821

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Immune Oncology Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed/refractory lymphomas. Participants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.

Detailed description

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

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Balstilimab	An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody

Timeline

• Start date: 2023-09-01
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2023-06-07
• Last updated: 2025-05-08

Locations

1 site across 1 country: Armenia

Regulatory

• FDA-regulated drug study