Actively Recruiting
Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study
Led by Hebei Senlang Biotechnology Inc., Ltd. · Updated on 2026-02-27
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study on the Use of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis: A Preliminary Exploration of 12-Week Clinical Remission with Autologous CAR-T Cell Injection in Refractory and Relapsing Ulcerative Colitis.
CONDITIONS
Official Title
Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject or guardian must provide voluntary informed consent
- Diagnosed with ulcerative colitis based on clinical, imaging, pathological, and endoscopic assessments, with follow-up over 3 months
- Moderate to severe active ulcerative colitis with a clinical modified Mayo score of 6-12 and endoscopic Mayo score 8 2 within 10 days prior to baseline
- Previous treatment failure with all approved UC medications including immunosuppressive drugs, biologics, and small molecules
- Hematological, liver, kidney, cardiopulmonary, and coagulation functions meet required criteria
You will not qualify if you...
- Women who are pregnant or lactating
- Any condition increasing risk or affecting trial results as judged by the Investigator
- Diagnosis of Crohn's Disease, indeterminate colitis, or other colitis/enteritis types confounding efficacy
- Fulminant colitis and/or toxic megacolon
- Ulcerative colitis limited to the rectum
- Current or likely need for colostomy or ileostomy
- Previous total proctocolectomy or partial colectomy
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody with detectable HBV DNA, hepatitis C virus antibodies and RNA, HIV antibodies, cytomegalovirus DNA, Epstein-Barr virus DNA, or syphilis antibodies
- Uncontrolled active infections at consent
- Severe, opportunistic, or chronic/recurrent extra-intestinal infections within 2 months prior to screening
- Active or latent tuberculosis or active herpes zoster infection within specified timeframes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Foresea Life Insurance Guangzhou General Hospital
Guangzhou, China
Actively Recruiting
Research Team
Y
Yingdi Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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