Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Trial end date:
2028-12-30
Target enrollment:
Participant gender:
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 1010 CAR+T cells/kg respectively. The initial dose group is 310 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.
Phase:
EARLY_PHASE1
Details
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology