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

NCT07544160 | Not Yet Recruiting Phase 1

• 1 other identifier: ICG318-002
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases (IBD)

Keywords

Ulcerative Colitis; Crohn's disease; Inflammatory Bowel Disease; IBD; UC; CD; CAR-T; Cellular Therapy

Outcome Measures

Primary Outcomes (1)

• 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).

  Starting day 0 and up to 2 years after ICG318 CAR-T infusion.

Secondary Outcomes (19)

• Determine the recommended phase 2 dose (RP2D) regimen.

  Starting day 0 and assessed 2 years after ICG318 CAR-T infusion.

• The proportion of subjects who achieved drug-free remission.

  At 6 months, 12 months, 24 months after ICG318 CAR-T infusion.

• Fecal calprotectin levels.

  28 days, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.

• Cmax

  Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.

• Tmax

  Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.

Study Arms (1)

Single Arm Biologic Infusion

EXPERIMENTAL

Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T

Interventions

ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T BIOLOGICAL

Anti-BCMA, Anti-CD19 Compound CAR-T cells

Single Arm Biologic Infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Infectious diseases: subjects with acute, life-threatening bacterial, viral or fungal infections that have not been controlled.
• Hospitalization for IBD-related complications within 30 days prior to screening.
• ） Clinically significant central nervous system disease determined by the investigator to impair the subjects ability to participate safely in this trial.
• ） Subjects with prior or concurrent malignancies. Exceptions may be determined at the discretion of the investigator.
• ） Vaccination within 30 days before screening and vaccination within 3 months after planned cell ICG318 CAR-T infusion.
• ） Subjects who are receiving or have received another investigational drug or drugs without adequate washout time as determined by the principal investigator.
• ） 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.

Sponsors & Collaborators

• iCell Gene Therapeutics: lead
• iCAR Bio Therapeutics Ltd.: collaborator

Study Sites (1)

Zhongshan people's hospital

Zhongshan, Guangdong, 528403, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

Kevin Pinz, MS

CONTACT

6315386218; kevin.pinz@icellgene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 22, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 7, 2028
• Study Completion (Estimated): April 7, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)