Actively Recruiting
Study of XKDCT225 (Claudin18.2-CAR-T) Cell Injection in Claudin18.2-Positive Advanced Solid Tumors Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy in a Single-Arm, Dose-Escalation Trial
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
Researchers are investigating the safety, tolerability, pharmacokinetics, and preliminary efficacy of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid tumors who have not responded to or cannot tolerate standard treatments. This Phase 1, single-center, single-arm, dose-escalation trial focuses on tumors with moderate to high Claudin18.2 expression. The study enrolls 9 to 18 patients and uses accelerated titration and 3+3 dose-escalation designs to explore the effects of the treatment. Participants receive a single infusion of the autologous targeted Claudin18.2 chimeric antigen receptor T cell injection (XKDCT225). The study evaluates escalating doses to identify dose-limiting toxicities and maximum tolerated dose. Patients are monitored closely during the 28 days following infusion to assess these safety markers. Throughout the trial, researchers conduct imaging to evaluate tumor lesions and perform laboratory tests to monitor blood counts, liver and kidney function, and coagulation. They also track adverse events over one year to assess safety. The study measures treatment pharmacokinetics and observes anti-tumor responses, with participant involvement lasting through the dose-escalation and follow-up periods to gather comprehensive safety and efficacy data.
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
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Trial Site Locations
Total: 1 location
1
AnYang Tumor Hospital
Anyang, Henan, China, 455000
Actively Recruiting
Research Team
B
Baozhong Li
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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