Tests a cell therapy in adults with hard-to-treat inflammatory bowel disease
Tests ICG318 CAR-T cells for safety in adults with relapsed or refractory inflammatory bowel disease.
Plain-language title generated from the registry record
Registry title: BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
Key facts
- Where
- Zhongshan, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07544160, who can take part
Where in China
- Zhongshan People's HospitalZhongshan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iCell Gene Therapeutics
- Trial code
- NCT07544160
- Record updated
- 22 April 2026
- Original description
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with relapsed and/or refractory inflammatory bowel disease.Read full original descriptionShow less
A Single-arm, Open-label Phase I Clinical Study to Evaluate ICG318 CAR-T in Adults With Refractory Inflammatory Bowel Disease
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of ICG318 CAR-T (BCMA-CD19-IL-15/IL15sushi cCAR T cells) in patients with relapsed and/or refractory inflammatory bowel disease.
Inclusion: All subjects or legal guardians must sign an ethics committee-approved informed consent form in writing prior to initiation of any screening procedures; Male or female subject over 18 years old and under 70 years old at the time of evaluation; Weight ≥ 40 kg; Diagnosed with inflammatory bowel disease assessed by the investigator and the disease course has been ≥ 3 months before signing informed consent (clinical manifestations, endoscopy and histopathological reports consistent with the diagnosis of inflammatory bowel disease are required); The subject has documented inadequate response, loss of response, or intolerance to at least one advanced therapy for IBD; Patients with IBD during the screening period need to meet the requirements of moderate to severe IBD; UC: active ulcerative colitis, defined as per the adapted Mayo score criteria. CD: CD subjects with moderate to severe active CD, defined as interpreted by SES-CD; Life expectancy greater than 6 months; Female individuals with fertility (defined as all females who are physiologically capable of becoming pregnant) must provide informed consent, have a negative blood pregnancy test result, and agree to use highly effective contraception from the time of informed consent until 1 year after CAR-T cell infusion. Male individuals with fertility must agree to use effective barrier contraception from the time of informed consent until 1 year after CAR-T cell infusion, and should not donate semen or sperm during the entire study period; Indeterminate colitis is permitted.
Exclusion: Subjects who have previously received any BCMA and/or CD19 targeted cell therapy products or CAR-T therapy for any target before signing the informed consent form; Hospitalization for IBD-related complications within 30 days prior to screening; 11） Clinically significant central nervous system disease determined by the investigator to impair the subjects ability to participate safely in this trial; 12） Subjects with prior or concurrent malignancies. Exceptions may be determined at the discretion of the investigator; 13） Vaccination within 30 days before screening and vaccination within 3 months after planned cell ICG318 CAR-T infusion; 14） Subjects who are receiving or have received another investigational drug or drugs without adequate washout time as determined by the principal investigator; 15） Those who are judged by the investigator to be unfit for leukapheresis, or whose IBD disease severity and trajectory are not compatible with infusion with ICG318 CAR-T cells, or any critical steps of the trial evaluation such as but not limited to contraindications to colonoscopy; 16） Female subjects who are pregnant or lactating. 17） Autoimmune diseases judged by the investigator to require systemic treatment and affect the evaluation of efficacy; 18） Suicidal tendencies, tobacco use, substance use, or alcohol abuse as determined by the investigator; 19） Those who have a history of a severe drug allergy, or are allergic to the test drug ingredients, excipients or combined therapeutic drugs; 20） Other conditions that the investigator believes should not participate in this clinical trial; Undiagnosed type colitis, fulminant colitis, Hirschsprung-associated enterocolitis (HAEC), microscopic colitis, ischemic colitis, radiation colitis, colitis-related diverticular disease, or other colitis or enteritis type that may confound the evaluation of efficacy; Subjects with malignant tumors or dysplasia on endoscopy; Active hepatitis B, HCV positive, HIV antibody positive, Treponema pallidum antibody positive, Active tuberculosis; History of bleeding within 30 days determined by the investigator to exclude the patient; Infectious diseases: subjects with acute, life-threatening bacterial, viral or fungal infections that have not been controlled; Subjects with severely impaired vital organ function; Impaired bone marrow function; Presence of any IBD related complications determined by the investigator to interfere with the study of ICG318 CAR-T in refractory IBD.