MedTrace Logo

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

NCT07309744 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Principal Investigators

  • Xiaohua Hou, Prof. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-20
Primary Completion
2027-12-30
Completion
2028-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309744 on ClinicalTrials.gov