NCT07309744

Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease

Clinical Study on Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase I, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). The enrolled population consists of patients with refractory moderate-to-severe inflammatory bowel disease who have received multiple lines of biologic therapy. Two cohorts are established in the study to explore the optimal biological dose (OBD) for each indication: Cohort 1: Ulcerative Colitis Cohort Cohort 2: Crohn's Disease Cohort The study presets 3 dose groups, which are 3, 6, and 10×10⁶ CAR+T cells/kg respectively. The initial dose group is 3×10⁶ CAR+T cells/kg (Dose Group 1), and dose de-escalation or escalation may be conducted based on the assessment of the Safety Review Committee (SRC). It is expected that no more than 9 patients will be enrolled in each cohort.

Conditions

• Moderate-to-severe Ulcerative Colitis
• Crohn's Disease (CD)

Interventions

Type	Name	Description
DRUG	RD06-05 CART Cell Infusion	Participent will receive the infusion of RD06-05 cell injection with dosage of 3, 6, or 10×10⁶ CAR+T cells/kg respectively

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China