An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors

An Early Clinical Study to Evaluate the Safety and Efficacy of CLDN18.2 CAR T Cell Injection in Subjects With CLDN18.2-Positive Advanced Malignant Solid Tumors

An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.

This study is an open, single/multiple infusion, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of CAR-CLDN18.2 T cell therapy, and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumor with positive claudin 18.2 expression and failed to standard systemic treatment.

Inclusion Criteria:

• Willing to sign the Informed Consent Form (ICF) and comply with predefined visits and related procedures;
• Age 18 to 75, male or female;
• Cytology or histology confirmed advanced malignant solid tumors, with moderate to high expression of CLDN18.2;
• Locally advanced or metastatic solid tumors that are failed of, or refractory to, or contraindicated for standard of care;
• ECOG PS 0-1;
• The life expectency ≥ 3 months;
• Has sufficient organ and bone marrow function.

Exclusion Criteria:

• Have active central nervous system metastases or infiltration;
• Has previously received a bone marrow or organ transplant (including, but not limited to, a liver transplant) or is awaiting a transplant;
• History of or concurrent other malignancies (cured cervical carcinoma in situ with no recurrence within at least 2 years prior to screening, non-invasive basal cell or squamous cell carcinoma of the skin, locally advanced prostate cancer treated with radical surgery, or post-radical surgery ductal carcinoma in situ may be eligible for the study).
• Infectious disease;
• Adverse events caused by prior anti-tumor therapy that have not resolved to grade 1 or baseline, except for alopecia, grade 2 peripheral neuropathy, and stable hypothyroidism with hormone replacement therapy;
• Have received live attenuated vaccine within one month before screening, or plan to receive live attenuated vaccine during the study;
• Have major surgery (except liver space-occupying biopsy) within one month before screening, or have planned major surgery during the study.