Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen University General Hospital
About this trial
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 (≥ 18, ≤ 75), regardless of gender;
Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017);
According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;
Disqualifiers
People who have a history of allergy to any component in cell products;
The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ；
The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl;
According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography;
Trial design
Design model
Single group
Treatments tested in this trial
Claudin18.2 CAR-T cells
Biological/Vaccinepatients treated with Claudin18.2 CAR-T cells
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AE/SAE
adverse events/ severe adverse events
Time frame
From date of infusion to 30 days after infusionSecondary outcomes
1
ORR
overall response rate
Time frame
From admission to the end of follow up, up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov