← Back to all trials
Recruiting
NCT05811975
KSX01-TCRT Injection Project in Solid Tumors
Conditions: TCR-T Cells, Refractory Solid Tumors, Relapsed Solid Tumors
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 50
Sponsor: TCRx Therapeutics Co.Ltd
Location: The first affiliated hospital of Guang Xi medical university Nanning Guangxi
Summary
1\) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
Eligibility Criteria
Inclusion Criteria:
* 1\) Voluntary participation in clinical research; Fully understand the study and voluntarily sign an informed consent form; Willing to follow and capable of completing all test procedures.
* 2\) Age: 18 to 70 years old (including boundary value).
* 3\) Malignant solid tumors that have failed standard treatment or currently have no standard treatment available.
* 4\) Patients with tumor lesions that can be punctured and can be screened for a pharmaceutically acceptable TCR sequence can be enrolled in the study.
* 5\) Remission from previous surgical or treatment related adverse events to a level of 0-1, stable, or acceptable for inclusion/exclusion criteria (according to NCI CTCAE Version 5.0), or to an acceptable level for inclusion/exclusion criteria; Except for other toxicity that researchers believe does not pose a safety risk to the subject, such as hair loss, pigmentation, and peripheral neuropathy.
* 6\) Adequate organ function (without medical support such as blood transfusion, granulocyte colony stimulating factor, etc. during pre harvest and baseline periods) is defined as follows:
* 6.1) Blood system:
* 6.1.1) Hemoglobin 90 g/L (no blood transfusion or erythropoietin treatment within 14 days before the first administration);
* 6.1.2) The absolute value of neutrophils is 1.5 109/L (no treatment with granulocyte colony stimulating factor or granulocyte macrophage colony stimulating factor within at least 14 days before chemotherapy);
* 6.1.3) Platelet count is 100 109/L in the absence of significant liver lesions (primary or metastatic), or 75 109/L in the presence of liver lesions (no platelet transfusion, thrombopoietin, or interleukin-11 treatment was received within 14 days before the first administration);
* 6.1.4) Absolute lymphocyte count (ALC) 0.7 109/L;
* 6.2) Liver function:
* 6.2.1) Total bilirubin (TBIL) ≤ 2.0 in the absence of significant liver lesions (primary or metastatic) × Upper limit of normal (ULN), subjects with liver lesions or Gilbert disease ≤ 3 × ULN;
* 6.2.2) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 × ULN (liver metastasis or hepatocellular carcinoma can be ≤ 5 × ULN); Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN);
* 6.3) Renal function:
* 6.3.1) Creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula: (\[140 age\] × Body weight \[kg\] × \[0.85, female only\])/(72 × Creatinine (mg/dl));
* 6.3.2) Qualitative determination of urinary protein ≤ 1+; If the qualitative analysis of urine protein is ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative analysis is\
Source: ClinicalTrials.gov (NCT05811975). StuddyBuddy aggregates publicly available trial information.