💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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