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

Lymphoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT05891821
• Study type: Interventional
• Source: Immune Oncology Research Institute
• Contact: Astghik Voskanyan, MD
• Phone: +374 (10) 283800
• Email: astghikvos@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Completion date: September 2029