BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD) (NCT07544160) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
China18 participantsStarted 2026-04-07
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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 criteria
What they're measuring
1
Number of Adverse Events (AEs) after ICG318 CAR-T infusion.
Timeframe: Starting day 0 and up to 2 years after ICG318 CAR-T infusion.
. 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.
✕. 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.
✕. Subjects with severely impaired vital organ function.
✕. Impaired bone marrow function.
✕. Active hepatitis B, HCV positive, HIV antibody positive, Treponema pallidum antibody positive, Active tuberculosis.
✕. Presence of any IBD related complications determined by the investigator to interfere with the study of ICG318 CAR-T in refractory IBD.
✕. History of bleeding within 30 days determined by the investigator to exclude the patient.