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.
The subject or guardian must provide voluntary informed consent;
Diagnosis based on the "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)": Patients diagnosed with UC (based on comprehensive evaluation including clinical, imaging, pathological, and endoscopic assessments), with a follow-up period of more than 3 months;
Moderate to severe active ulcerative colitis: Patients meeting the criteria of a clinical modified Mayo score of 6-12 points and an endoscopic Mayo score (ES) ≥ 2 points (within 10 days prior to baseline);
Previous treatments with all domestically approved medications for UC, including conventional immunosuppressive drugs, biologics, and small molecule drugs, have failed;
Women who are pregnant or lactating;
Any condition that, in the judgment of the Investigator, could increase the subject's risk or compromise the interpretation of the trial results;
Diagnosed with CD (Crohn's Disease) or indeterminate colitis (IBD-unclassified), or other types of colitis or enteritis that may confound efficacy assessment;
Currently diagnosed with fulminant colitis and/or toxic megacolon;
Single group
BCMA CAR-T or CD19 CAR-T or CD19×BCMA
DrugAutologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1\*10\^6/kg, intravenous injection once
Incidence of CRS and ICANS
Evaluate the occurrence of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.
Clinical response rate: 12 weeks and 52 weeks
Clinical response (based on MMS): MMS decreases by ≥2 points and ≥30% from baseline, along with a reduction in RBS by ≥1 point or an RBS absolute value ≤1.
Clinical remission rate: 12 weeks and 52 weeks
Clinical remission (based on MMS): ES is 0 or 1, no fragility, RBS is 0, and SFS is 0 or 1 and not greater than baseline.
Endoscopic mucosal healing rate: 12 weeks and 52 weeks
No ulcers are observed on endoscopy.
Endoscopic response rate: 12 weeks and 52 weeks
Endoscopic remission: ES = 0.
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