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RECRUITINGEarly Phase 1INTERVENTIONAL

Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study

A Single-Center, Open-Label, Single-Arm Exploratory Clinical Study of Autologous CAR-T Cell Therapy Injection for the Treatment of Refractory and Relapsing Ulcerative Colitis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - The subject or guardian must provide voluntary willing to sign a consent form; - 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; - Hematological, liver and kidney function, cardiopulmonary function, and coagulation function meet specific criteria. Who Should NOT Join This Trial: - 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; - UC limited to the rectum; - Currently or likely to require colostomy or ileostomy; - Has previously undergone total proctocolectomy or partial colectomy. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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; * Hematological, liver and kidney function, cardiopulmonary function, and coagulation function meet specific criteria. Exclusion Criteria: * 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; * UC limited to the rectum; * Currently or likely to require colostomy or ileostomy; * Has previously undergone total proctocolectomy or partial colectomy. * Patients who test positive for hepatitis B surface antigen (HBsAg) should be excluded; if HBsAg is negative but hepatitis B core antibody (HBcAb) is positive, and peripheral blood HBV DNA is above the detection limit, they should be excluded; patients who test positive for hepatitis C virus (HCV) antibodies and HCV RNA should be excluded; patients who test positive for human immunodeficiency virus (HIV) antibodies; patients who test positive for cytomegalovirus (CMV) DNA; patients who test positive for Epstein-Barr virus (EBV) DNA; patients who test positive for both treponemal-specific antibodies and non-specific antibodies for syphilis should be excluded. * Any uncontrolled active infection present at the time of signing the ICF. * Subjects who have had severe, opportunistic, or chronic/recurrent extra-intestinal infections within 2 months prior to screening; evidence of active/infectious herpes zoster infection within 8 weeks prior to screening; active tuberculosis or latent tuberculosis infection present at screening.

Treatments Being Tested

DRUG

BCMA CAR-T or CD19 CAR-T or CD19×BCMA

Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells, dosage 1\*10\^6/kg, intravenous injection once

Locations (1)

Foresea Life Insurance Guangzhou General Hospital
Guangzhou, China