NCT07435779

Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study

A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection in Refractory and Relapsing Ulcerative Colitis.

Detailed description

The primary objective： Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis. The secondary objectives： Evaluate the 12-Week and 52-Week Clinical Response Rates, Endoscopic Parameters (Endoscopic Response Rate, Endoscopic Remission Rate, Mucosal Healing), Ultrasound and Imaging (Response Rate, Remission Rate), Improvement in Quality of Life, and Safety of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis.

Conditions

• UC

Interventions

Type	Name	Description
DRUG	BCMA CAR-T or CD19 CAR-T or CD19×BCMA	Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1\*10\^6/kg, intravenous injection once

Timeline

• Start date: 2026-02-04
• Primary completion: 2027-02-04
• Completion: 2028-02-04
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: China