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Recruiting Early Phase 1

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

NCT07435779 · tracked via the Priya Life Science China tracker
Phase
Early Phase 1
Started
2026-02-04
Last updated
2026-02-27

Condition(s) studied

UC

Investigational drug(s) / intervention(s)

BCMA CAR-T or CD19 CAR-T or CD19×BCMA →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of CRS and ICANS — 28 days
    Evaluate the occurrence of cytokine release syndrome and severe neurotoxic adverse events within 28 days after CAR-T cell infusion.

Trial sites (1)

FacilityCityRegionStatus
Foresea Life Insurance Guangzhou General Hospital Guangzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07435779 on ClinicalTrials.gov ↗ ← All trials in China