NCT07435779 Autologous CAR-T Cell Therapy for Refractory and Relapsing Ulcerative Colitis: A Single-Center Exploratory Study
| NCT ID | NCT07435779 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Hebei Senlang Biotechnology Inc., Ltd. |
| Condition | UC |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2027-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-02-04 with a primary completion date of 2027-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jianping Wang
PRINCIPAL INVESTIGATOR
Foresea Life Insurance Guangzhou General Hospital
Frequently Asked Questions
Who can join the NCT07435779 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying UC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07435779 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07435779 currently recruiting?
Yes, NCT07435779 is actively recruiting participants. Contact the research team at chenyd193@163.com for enrollment information.
Where is the NCT07435779 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07435779 clinical trial?
NCT07435779 is sponsored by Hebei Senlang Biotechnology Inc., Ltd.. The principal investigator is Jianping Wang at Foresea Life Insurance Guangzhou General Hospital. The trial plans to enroll 12 participants.