NCT07316907

A Clinical Study of Allogenic CD19-CAR-T in the Treatment of R/R B-Cell Hematologic Malignancies

An Exploratory Clinical Study of the Safety and Efficacy of Allogenic CD19-Targeted Chimeric Antigen Receptor T-Cell Injection in the Treatment of Relapsed/Refractory B-Cell Hematologic Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: YANRU WANG · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label pilot study to evaluate the safety and efficacy of CD19-targeted allogenic CAR-T cells (19UCART) in patients with relapsed/refractory B-cell hematologic malignancies. 12 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The secondary objective is to evaluate the efficacy of 19UCART for the treatment of relapsed/refractory B-cell hematologic malignancies. The exploratory objective is to evaluate expansion, persistence and ability of 19UCART to deplete CD19 positive cells in patients with relapsed/refractory B-cell hematologic malignancies.

Conditions

• Hematologic Malignancies
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	19UCART injection	19UCART injection is a CD19-targeted allogenic CAR-T. A single infusion of CAR-T cells will be administered intravenously.

Timeline

• Start date: 2025-12-22
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2026-01-05
• Last updated: 2026-01-05

Locations

1 site across 1 country: China