Moderate to Severe Ulcerative Colitis

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Review clinical trials related to Moderate to Severe Ulcerative Colitis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 30
Trial details
Phase: Early Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUpdated: Dec 30, 2025Locations: 1
Eligibility criteria

The subject voluntarily participates in this trial and signs the informed consen... [+23]

Presence of other coexisting autoimmune diseases that may significantly interfer...