NCT07369492

Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma

A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory 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 evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.

Detailed description

This is a prospective open-label, single-arm clinical study to evaluate the safety, tolerability of BAFF-R CAR-T cells in adult subjects with CD19-negative relapsed or refractory B-Cell Lymphoma. 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 BAFF-R CAR-T cells in CD19-negative relapsed or refractory B-Cell Lymphoma, 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

• B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	BAFF-R CAR-T cells	BAFF-R CAR-T cells, single intravenous infusion

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2026-01-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China