Inflammatory Bowel Diseases (IBD)Phase 1/2NCT07544160
BCMA-CD19 cCAR T for the Treatment of Refractory Inflammatory Bowel Disease (IBD)
A Phase 1/2 study testing ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T in people with Inflammatory Bowel Diseases (IBD), run by iCell Gene Therapeutics at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases (IBD)
- What is being tested?
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2026to 7 Apr 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan people's hospital
Zhongshan, Guangdong, 528403
Weishan Ruan, M.D., Ph.D., +86 0760 88823566, zsruanws@163.com
About this study
Official title: 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.
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic, immune-mediated disease of the gastrointestinal (GI) tract. IBD may result in GI lesions as well as extraintestinal manifestations affecting the joints, skin, eyes, and biliary system. IBD is driven by humoral immune cells including B cells, plasma cells and long-lived plasma cells.
ICG318 CAR-T, the investigational agent in this clinical trial, is an armored, compound chimeric antigen receptor (cCAR) composed of two independently functioning CARs that target the CD19 surface antigen and the BCMA surface antigen on B cells and plasma/long-lived plasma cells, respectively.
This study is being conducted to evaluate the safety and efficacy of ICG318 CAR-T in patients with refractory IBD. A single dose of ICG318 CAR-T will be evaluated after cyclophosphamide and fludarabine lymphodepletion.
- Conditions
- Inflammatory Bowel Diseases (IBD)
- Being tested
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T
- Keywords
- Ulcerative Colitis, Crohn's disease, Inflammatory Bowel Disease, IBD, UC, CD, CAR-T, Cellular Therapy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR TBiological
Anti-BCMA, Anti-CD19 Compound CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Biologic Infusion | Experimental | Not described Receives: Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Starting day 0 and up to 2 years after ICG318 CAR-T infusion.
Secondary outcomes (19)
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.
Measured: Starting day 0 and assessed 2 years after ICG318 CAR-T infusion.
The proportion of subjects who achieved drug-free remission.
Clinical, endoscopic, and histological remission maintained without any IBD-directed therapy.
Measured: At 6 months, 12 months, 24 months after ICG318 CAR-T infusion.
Fecal calprotectin levels.
Measured: 28 days, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
Cmax
Maximum serum concentration of ICG318 CAR-T.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Tmax
Time to maximum serum concentration of ICG318 CAR-T.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
T1/2
Half-life of ICG318 CAR-T serum concentration.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
AUC
Plasma ICG318 CAR-T concentration versus time. Total systemic exposure to ICG318 CAR-T over time.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Rate of B cell elimination and naïve B-Cell recovery
B cell subsets will be assessed by flow cytometry panels and B-Cell receptor sequencing.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Recovery of immunoglobulins
Immunoglobulins IgG, IgM and IgA levels.
Measured: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical remission from Crohn's Disease (CD)
CD activity index (CDAI) remission
Measured: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical response from CD
CDAI reduction
Measured: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic remission from CD
SES-CD remission.
Measured: 12 months, 24 months after ICG318 CAR-T.
The proportion of subjects who achieved endoscopic response from CD
SES-CD reduction
Measured: 12 months, 24 months after ICG318 CAR-T.
Histological Remission from CD
Absence of inflammation on tissue samples collected from endoscopic biopsy.
Measured: 12 months, 24 months after ICG318 CAR-T.
The proportion of subjects who achieved clinical remission from Ulcerative Colitis (UC)
Adapted Mayo score remission.
Measured: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical response from UC
Adapted Mayo score response.
Measured: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic remission from UC
Mayo Endoscopic Subscore (MES) remission.
Measured: 12 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic response from UC
MES response.
Measured: 12 months, 24 months after ICG318 CAR-T infusion.
Histological remission from UC
Nancy Histological Index (NHI) scoring. Evaluation performed on tissue samples collected from endoscopic biopsy.
Measured: 12 months, 24 months after ICG318 CAR-T infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start7 Apr 2026 (estimated)
- Primary completion7 Apr 2028 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCell Gene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544160
- Sponsor's protocol ID
- ICG318-002
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Phase I Clinical Study to Evaluate ICG318 CAR-T in Adults With Refractory Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07544160
- Acronym / sponsor ID
- ICG318-002
- Conditions
- Inflammatory Bowel Diseases (IBD)
- Keywords
- Ulcerative Colitis, Crohn's disease, Inflammatory Bowel Disease, IBD, UC, CD, CAR-T, Cellular Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- iCell Gene TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- iCAR Bio Therapeutics Ltd.
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- 7 Apr 2028 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Inflammatory bowel disease (IBD) is a chronic, immune-mediated disease of the gastrointestinal (GI) tract. IBD may result in GI lesions as well as extraintestinal manifestations affecting the joints, skin, eyes, and biliary system. IBD is driven by humoral immune cells including B cells, plasma cells and long-lived plasma cells.
ICG318 CAR-T, the investigational agent in this clinical trial, is an armored, compound chimeric antigen receptor (cCAR) composed of two independently functioning CARs that target the CD19 surface antigen and the BCMA surface antigen on B cells and plasma/long-lived plasma cells, respectively.
This study is being conducted to evaluate the safety and efficacy of ICG318 CAR-T in patients with refractory IBD. A single dose of ICG318 CAR-T will be evaluated after cyclophosphamide and fludarabine lymphodepletion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Biologic Infusion | Experimental | Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR TAnti-BCMA, Anti-CD19 Compound CAR-T cells | Biological | Single Arm Biologic Infusion |
Primary outcome
Number of Adverse Events (AEs) after ICG318 CAR-T infusion.
Time frame: Starting day 0 and up to 2 years 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).
19 secondary outcomes
Determine the recommended phase 2 dose (RP2D) regimen.
Time frame: Starting day 0 and assessed 2 years after ICG318 CAR-T infusion.
The proportion of subjects who achieved drug-free remission.
Time frame: At 6 months, 12 months, 24 months after ICG318 CAR-T infusion.
Fecal calprotectin levels.
Time frame: 28 days, 2 months, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
Cmax
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Tmax
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
T1/2
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
AUC
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Rate of B cell elimination and naïve B-Cell recovery
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
Recovery of immunoglobulins
Time frame: Assessed as per schedule of events up to 2 years after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical remission from Crohn's Disease (CD)
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical response from CD
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic remission from CD
Time frame: 12 months, 24 months after ICG318 CAR-T.
The proportion of subjects who achieved endoscopic response from CD
Time frame: 12 months, 24 months after ICG318 CAR-T.
Histological Remission from CD
Time frame: 12 months, 24 months after ICG318 CAR-T.
The proportion of subjects who achieved clinical remission from Ulcerative Colitis (UC)
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved clinical response from UC
Time frame: 3 months, 6 months, 12 months, 18 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic remission from UC
Time frame: 12 months, 24 months after ICG318 CAR-T infusion.
The proportion of subjects who achieved endoscopic response from UC
Time frame: 12 months, 24 months after ICG318 CAR-T infusion.
Histological remission from UC
Time frame: 12 months, 24 months after ICG318 CAR-T infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T in people with Inflammatory Bowel Diseases (IBD), run by iCell Gene Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Pinz, MS (6315386218, kevin.pinz@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) after ICG318 CAR-T infusion. (time frame: Starting day 0 and up to 2 years after ICG318 CAR-T infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.