NCT05680038

Penpulimab in Maintenance Therapy in Lymphoma

A Real-world Study of Efficacy and Safety of Penpulimab in Maintenance Therapy in Patients With Post-transplant or Transplant-intolerant Lymphoma

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 167 (estimated)
• Sponsor: WEI XU · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Panpulimab is a modified PD1 inhibitor, which innovated the use of IgG1 subtype. On the basis of ensuring the stability of the antibody, it eliminated ADCC, ADCP, CDC and other effects that were not conducive to the efficacy of T cells and reduced the effect of ADCR by modifying the Fc segment. There have been no studies on the safety and efficacy of Panpulimab in maintenance therapy after transplantation or in patients with transplant-intolerant lymphoma. The maintenance treatment of Panpulimab in our center has been preliminarily explored in clinic, and the results show good efficacy and safety. Therefore, based on the mechanism of PD1 monoclonal antibody maintenance therapy in lymphoma and the results of related clinical studies, this study proposed a regimen of peamprilizumab maintenance therapy for post-transplant or transplant intolerant lymphoma patients in real world studies, with the main purpose of observing the efficacy and safety of this regimen in lymphoma patients.

Detailed description

After the completion of first-line induction and consolidation therapy, the lymphoma patients who received transplantation or were intolerant to transplantation were treated with Panpulimab monotherapy, 200 mg, once every three weeks, and were evaluated after six months of maintenance therapy. The patients who were evaluated as CR were excluded from the group, and the patients who did not reach CR were continued to take medication until CR. Review every 3 months from the first year of maintenance treatment and every 6 months from the second year to the fifth year.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Penpulimab	Penpulimab is a modified PD1 inhibitor, which innovated the use of IgG1 subtype. On the basis of ensuring the stability of the antibody, it eliminated ADCC, ADCP, CDC and other effects that were not conducive to the efficacy of T cells and reduced the effect of ADCR by modifying the Fc segment

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2023-01-11
• Last updated: 2023-01-11