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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
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.
Details
| Lead sponsor | Jiangsu Topcel-KH Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 30 |
| Start date | 2026-01 |
| Completion | 2029-01 |
Conditions
- Diffuse Large B Cell Lymphoma
Interventions
- Anti-PD1 armored CD19 CAR-T cells
Primary outcomes
- Incidence of dose-limiting toxicity (DLT) — 1 month after injection
Dose-limiting toxicity for each subject - AE/SAE — 1 month, 3 months, 6 months, 12 months after injection
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
Countries
China