Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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;

• Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;

• Subjects must have received the first and second line standard treatment scheme;

• The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and/or surgery/immunosuppressant at the checkpoint, or refuse surgical resection

• Within 2 weeks before cell therapy, no antibody drugs were used;

• ECOG score is 0-2;

⁃ The subjects had no contraindication for peripheral blood collection;

⁃ The expected survival period is more than 3 months.

Locations
Other Locations
China
Li Yu
RECRUITING
Shenzhen
Contact Information
Primary
Li Yu, Dr
liyu@vip.163.com
+8675521839178
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 20
Treatments
Experimental: Treatment group
Patients treated with Claudin 18.2 CAR-T cells.
Related Therapeutic Areas
Sponsors
Leads: Shenzhen University General Hospital

This content was sourced from clinicaltrials.gov

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