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.
The subject voluntarily participates in this trial and signs the informed consent form.
Aged ≥ 18 years and ≤ 70 years, regardless of gender.
Liver function: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2 × Upper Limit of Normal (ULN); Total Bilirubin (TBIL) ≤ 2 × ULN (except for Gilbert's syndrome).
Renal function: Creatinine ≤ 1.5 × ULN or Creatinine Clearance ≥ 40 ml/min.
Presence of other coexisting autoimmune diseases that may significantly interfere with the attribution of study disease activity or pose additional safety risks. However, if the subject's condition has been clinically stable for ≥ 3 months and is not expected to interfere with study assessments, enrollment may be permitted after confirmation by the investigator and the sponsor's medical monitor (or their designee).
Single group
RD06-05 CART Cell Infusion
DrugParticipent will receive the infusion of RD06-05 cell injection with dosage of 3, 6, or 10×10⁶ CAR+T cells/kg respectively
Incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Serious Adverse Events (SAEs)
Adverse Events of Special Interest (AESIs)
Proportion of Patients Achieving Clinical Remission
Proportion of Patients Achieving Histologic Remission
Proportion of Patients Achieving Clinical Response
Proportion of Patients Who Were on Oral Glucocorticoids at Baseline
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