Actively Recruiting
Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma
Led by Shenzhen University General Hospital · Updated on 2022-11-22
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying advanced pancreatic and gastric cancers, focusing on a protein called Claudin that is highly present in these cancer types. This research aims to test the safety and effectiveness of Claudin18.2 CAR-T cell therapy in patients with these advanced cancers, as current treatments need improvement. The study is led by Shenzhen University General Hospital and involves evaluating this new biological treatment. Participants in the study will receive Claudin18.2 CAR-T cells, which are designed to target cancer cells expressing the Claudin 18.2 protein. This treatment is given during the study period, and researchers will monitor its effects and safety. The study does not involve placebo or masking and includes patients with advanced, non-resectable cancers confirmed by pathology and specific criteria. During the trial, participants will be closely followed with careful monitoring of side effects from the infusion up to 30 days after treatment. Researchers will also assess tumor response and remission rates over up to two years. The study includes regular health assessments, blood tests, and tumor evaluations, with participants expected to have a survival outlook of more than three months. The total participation age range is 18 to 75 years old.
CONDITIONS
Brief Title
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Voluntary participation with signed informed consent
- Confirmed non-resectable, locally advanced recurrent or metastatic gastric or pancreatic cancer by histopathology
- Stage III or IV cancer according to the 8th edition AJCC TNM staging system
- Measurable and evaluable lesions according to RECIST 1.1 criteria
- Moderate to high Claudin 18.2 expression confirmed by immunohistochemistry
- Received first and second line standard treatments
- Not suitable for or refusing radical treatments like surgery, chemotherapy, radiotherapy, or immunosuppressants
- No antibody drugs used within 2 weeks before cell therapy
- ECOG performance status between 0 and 2
- No contraindications for peripheral blood collection
- Expected survival longer than 3 months
You will not qualify if you...
- History of allergy to any component of the cell products
- Abnormal blood counts: WBC ≤ 1 × 10⁹/L, ANC ≤ 0.5 × 10⁹/L, ALC ≤ 0.5 × 10⁹/L, or platelets ≤ 25 × 10⁹/L
- Abnormal liver or kidney function: bilirubin ≥ 1.5 mg/dl; ALT or AST > 2.5 times upper normal limit; creatinine ≥ 2.0 mg/dl
- Severe heart issues: NYHA class III or IV cardiac insufficiency or LVEF < 50%
- Low blood oxygen saturation (<92%) on room air
- Recent serious heart events within 12 months
- Grade 3 hypertension poorly controlled by medication
- History of serious brain injuries or neurological disorders
- Autoimmune diseases, immunodeficiency, or requiring immunosuppressive treatment
- Active uncontrolled infections
- Prior CAR-T or genetically modified T cell therapy
- Live vaccine received within 4 weeks before enrollment
- Positive for HIV, HBV, HCV, or syphilis
- History of alcohol or drug abuse, or mental illness
- Participation in other clinical trials within 3 months
- Pregnancy, breastfeeding, pregnancy plans, or inability to use effective contraception in women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From infusion to 30 days after infusion
Participants receive Claudin18.2 CAR-T cell therapy for advanced pancreatic or gastric cancer.
1 infusion visit and follow-up visits up to 30 days post-infusion
Duration - Up to 2 years
Participants are monitored for safety and efficacy outcomes for up to 2 years after treatment.
Periodic visits during follow-up up to 2 years
Trial Site Locations
Total: 1 location
1
Li Yu
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Li Yu, Dr
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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