Actively Recruiting
KSX01-TCRT Injection Project in Solid Tumors
Led by TCRx Therapeutics Co.Ltd · Updated on 2023-04-13
50
Participants Needed
1
Research Sites
303 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
KSX01-TCRT Injection Project in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 70 years inclusive
- Have malignant solid tumors unresponsive to or lacking standard treatments
- Have tumor lesions that can be safely biopsied for TCR sequence screening
- Recovery from prior treatment side effects to grade 0-1 or stable
- Adequate organ function without medical support including:
- Hemoglobin ≥90 g/L without recent transfusion or erythropoietin
- Neutrophils ≥1.5 x10^9/L without recent growth factor treatment
- Platelets ≥100 x10^9/L without liver lesions or ≥75 x10^9/L with liver lesions and no recent platelet-support treatments
- Absolute lymphocyte count ≥0.7 x10^9/L
- Liver enzymes and bilirubin within specified limits
- Creatinine clearance ≥50 ml/min
- Urine protein ≤1+ or ≤1 g/24h if higher
- Coagulation within specified ranges or stable anticoagulation therapy
- ECOG performance status 0-1
- Expected survival of at least 12 weeks
- At least one evaluable or measurable lesion per RECIST 1.1
- Sufficient blood cells can be collected for TCR-T cell preparation
- Autologous TCR-T cells of sufficient quantity and quality available for infusion
- Negative pregnancy test for women of childbearing age; use of approved contraception for women and men as specified
You will not qualify if you...
- History of severe allergies or allergies to study drug components
- Previous treatment with other cell or gene therapy products
- Significant bleeding or clotting disorders or recent bleeding events
- Unhealed wounds, ulcers, or fractures within 28 days
- Recent live or attenuated vaccines, cytotoxic chemotherapy, targeted therapy, major surgery, or certain medications within specified washout periods
- Presence of systemic bone metastases
- History of leptomeningeal cancer
- Brain metastases or spinal cord compression unless stable and asymptomatic
- Primary immune deficiency or active autoimmune disease with expected recurrence
- Active liver or biliary disease excluding specific conditions
- Recent serious cardiovascular events or unstable heart conditions
- Uncontrolled effusions
- Certain cardiac conditions or severe uncontrolled diseases
- Interstitial pneumonia or pulmonary fibrosis requiring oxygen
- Any condition increasing risk or interfering with treatment as judged by researchers
- Fever of unknown origin above 38.5°C
- Severe active infections within 4 weeks
- Positive tests for HIV, syphilis, hepatitis B or C with high viral loads
- Expected need for other anti-tumor therapies during study
- History of organ transplantation
- Pregnancy or breastfeeding
- History of substance abuse or significant neurological/mental disorders
- Other conditions deemed inappropriate by researchers for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of Guang Xi medical university
Nanning, Guangxi, China, 530000
Actively Recruiting
Research Team
C
clinical trials ksh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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