KSX01-TCRT Injection Project in Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRx Therapeutics Co.Ltd
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
KSX01-TCRT injection
Drugindividualization TCR-T cell injection
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: TCR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Subject safety
Number of participants with treatment-related adverse events assessed by CTCAE v4.0.
Time frame
about 2 years2
tumor efficacy
Changes in overall tumor diameter.
Time frame
about 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov