Actively Recruiting
A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory/Recurrent Solid Tumors
Led by TCRx Therapeutics Co.Ltd · Updated on 2023-04-03
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of KSH01-TCR-T cell therapy for adults aged 18 to 70 years with refractory or relapsed solid tumors. This early phase 1 study focuses on patients who have no standard treatment options, have failed previous treatments, or cannot tolerate standard therapies and whose tumors express the target protein. The study also aims to understand how these TCR-T cells activate and multiply in the body and to measure participants' survival time. Participants will receive an injection of KSH01 TCR-T cells, which are specially prepared immune cells designed to target tumor cells. The study includes a dose escalation phase for patients without other treatment options and a dose expansion phase for those who have progressed on first-line therapy. The treatment is personalized, using each participant's own cells, and patients must have tumors that express the target to qualify. The study monitors treatment-related side effects and changes in tumor size over about two years. Throughout the trial, participants will be closely monitored with regular assessments of tumor response, safety, and immune system markers over a period of up to five years. Researchers will collect biological samples and track any side effects, as well as the pharmacokinetic and biomarker profiles of the treatment. The study also evaluates the maximum tolerated dose and overall anti-tumor effects, ensuring careful observation of participants' health and treatment response.
CONDITIONS
Brief Title
KSH01-TCRT Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Male or female, aged 18 to 70 years
- Diagnosed with advanced malignant solid tumors confirmed by histology or cytology
- For dose escalation: no standard treatment available or failed/relapsed after standard treatment, or cannot tolerate standard treatment with positive target expression
- For dose expansion: target-positive subjects who progressed on first-line therapy
- Positive for HLA-A*02 and tumor target expression (≥30% of cancer cells with 2+ or 3+ staining intensity)
- Previous anti-tumor therapy toxicities resolved to grade 0-1 or acceptable level
- Adequate blood, liver, renal, and coagulation function without recent medical support
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- Able to provide sufficient peripheral blood mononuclear cells for TCR-T preparation
- Prepared autologous TCR-T cells meet quality and quantity standards for reinfusion
- Female participants with fertility potential have negative pregnancy test and agree to contraception
- Male participants agree to contraception and avoid sperm donation during and after treatment
- Provide tumor tissue specimens for target analysis with positive expression
You will not qualify if you...
- History of severe allergies or known allergy to study drugs/components
- Previous coronary artery reconstruction
- Significant bleeding disorders or recent bleeding events
- Recent anticoagulant or antiplatelet therapy beyond allowed exceptions
- Recent unhealed wounds, live vaccine, or certain chemotherapy treatments before reinfusion
- Recent corticosteroid use beyond allowed exceptions
- Known leptomeningeal or uncontrolled symptomatic central nervous system metastases
- Primary immunodeficiency
- Active or expected relapse of autoimmune diseases except specific stable conditions
- Recent major cardiovascular events or unstable cardiac conditions
- Uncontrolled pleural, pericardial, or ascites effusions
- Certain cardiac abnormalities and poorly controlled diabetes or hypertension
- Low lung function or need for supplemental oxygen
- Unexplained fever >38.5°C except tumor-related
- History of organ transplantation
- History of substance abuse
- History of neurological or mental disorders like epilepsy or dementia
- Known AIDS or severe active infections
- Positive tests for HIV, CMV, HSV, HPV, EBV, syphilis, or active hepatitis B/C
- Any condition increasing risk with study treatment or confounding safety assessments
- Expected to receive other antitumor treatments during study
- Pregnant or breastfeeding women
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 2 years
Participants receive KSH01-TCR-T cell injections as treatment for refractory or recurrent solid tumors.
Visit schedule depends on treatment administration and monitoring protocols
Duration - Up to about 3 years after treatment
Participants are monitored for safety and treatment effects after the treatment period.
Periodic visits for long-term monitoring
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
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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