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

NCT07435779 | Recruiting Early Phase 1 DMC

• 1 other identifier: S103IBD01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

UC

Keywords

UC；CAR-T

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (13)

• Clinical response rate: 12 weeks and 52 weeks

  1 year

• Clinical remission rate: 12 weeks and 52 weeks

  1 year

• Endoscopic mucosal healing rate: 12 weeks and 52 weeks

  1 year

• Endoscopic response rate: 12 weeks and 52 weeks

  1 year

• IBDQ score assessment

  1 year

Study Arms (1)

BCMA CAR-T or CD19 CAR-T or CD19×BCMA

EXPERIMENTAL

Autologous BCMA/CD19/CD19×BCMA-targeting CAR T cells

Drug: BCMA CAR-T or CD19 CAR-T or CD19×BCMA

Interventions

BCMA CAR-T or CD19 CAR-T or CD19×BCMA DRUG

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

Also known as: Biological: BCMA/CD19/CD19×BCMA CAR-T

BCMA CAR-T or CD19 CAR-T or CD19×BCMA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Foresea Life Insurance Guangzhou General Hospital

Guangzhou, China

RECRUITING

Study Officials

• Jianping Wang

  Foresea Life Insurance Guangzhou General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingdi Chen

CONTACT

13763381162; chenyd193@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 27, 2026
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 4, 2027
• Study Completion (Estimated): February 4, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)