NCT07368270

Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

A Prospective, Open-label and Single-arm Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma.

Detailed description

This is a prospective, open-label, single-arm clinical study to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).The study plans to explore across three dose levels (1.00 × 10\^6, 3.00 × 10\^6, 9.00 × 10\^6 CAR+ T cells/kg), and 6.00×10\^8 CAR+T cells as maximum dose, aiming to evaluate the safety, tolerability of anti-PD1 armored CD19 CAR-T Cells in r/r DLBCL, explore Maximum Tolerated Dose (MTD) and determine the recommended dose for Phase II. Besides, efficacy, pharmacokinetics and persistence profile of CAR-T cells are also study objectives.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Anti-PD1 armored CD19 CAR-T cells	Anti-PD1 armored CD19 CAR-T cells, single intravenous infusion

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2026-01-26
• Last updated: 2026-01-28

Locations

1 site across 1 country: China