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

Summary

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.

Eligibility

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.

Conditions2

Interventions2

Browse More Trials