Actively Recruiting
Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)
Led by Shenzhen Celconta Life Science Co., Ltd. · Updated on 2025-01-17
18
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors
CONDITIONS
Official Title
Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Advanced solid tumors with moderate to high Claudin18.2 expression (intensity 2+ or higher and tumor cell positive rate 250%) not relieved or progressing after adequate treatment
- At least one measurable lesion by RECIST 1.1 (non-lymph node lesion 210 mm or lymph node lesion short diameter 215 mm)
- Estimated life expectancy greater than 12 weeks
- ECOG physical status score of 0 or 1
- Laboratory tests meeting specified blood count, liver, kidney, and coagulation function thresholds
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and for one year after treatment
- Male participants with female partners of childbearing potential must use effective contraception or be surgically sterilized during and for one year after treatment
- Discontinuation of therapeutic steroids and immunosuppressive drugs at least 4 weeks before treatment, with some exceptions
- Willingness to participate and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Active infection requiring antibiotics
- Received immune cell therapy within one year
- Previous Claudin18.2 targeted therapy
- Live vaccine within 4 weeks prior to collection
- Surgery within 2 weeks before apheresis
- Active coronary heart disease or recent major arrhythmia requiring treatment (except certain conditions)
- Left ventricular ejection fraction below 50% or severe heart failure
- Uncontrolled diabetes or hypertension
- Active autoimmune disease requiring ongoing medication
- Other malignancies within 5 years excluding certain skin and cervical cancers
- Symptomatic central nervous system disease or tumor involvement
- Extensive tumor metastasis involving more than two organs or rapidly progressing tumor
- Difficult airway conditions
- Fingertip blood oxygen saturation below 95% before procedures
- Unstable or active gastrointestinal conditions requiring emergency treatment
- Pleural or abdominal effusion greater than grade 2 not controlled by drainage or diuretics
- Current use of anticoagulants that cannot be stopped
- Allergy or intolerance to study drugs or related medications
- Deemed unsuitable by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AnYang Tumor Hospital
Anyang, Henan, China, 455000
Actively Recruiting
Research Team
B
Baozhong Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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