BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)

Korábbi kezelés

• 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.

Más betegség

• 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.

Egyéb

• 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.

• 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.