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.
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.
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.
Sequential
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
Biological/VaccineAnti-BCMA, Anti-CD19 Compound CAR-T cells
Number of Adverse Events (AEs) after ICG318 CAR-T infusion.
Number of participants with AEs, Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), and Dose Limiting Toxicities (DLTs).
Determine the recommended phase 2 dose (RP2D) regimen.
The protocol is based on cohort schema with dose escalation from 1×10\^6/kg to 4×10\^6/kg.
The proportion of subjects who achieved drug-free remission.
Clinical, endoscopic, and histological remission maintained without any IBD-directed therapy.
Fecal calprotectin levels.
Cmax
Maximum serum concentration of ICG318 CAR-T.
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iCell Gene Therapeutics
Lead sponsor
iCAR Bio Therapeutics Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
