Actively Recruiting
Single Arm Clinical Study on the Safety and Efficacy of Personalized KSX01-TCRT in Patients With Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-03-26
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating personalized KSX01-TCRT cell therapy in patients with advanced solid tumors that are incurable or metastatic and have failed standard treatments. This early phase I clinical trial aims to investigate the safety and effectiveness of this therapy in a single-arm, open-label setting. The study is divided into two parts: a dose escalation phase and a dose expansion phase, where the dose used must have passed safety assessments during escalation. Participants receive personalized KSX01-TCRT, a biological therapy using their own T cells modified to target tumors. The trial begins with screening and tissue collection to identify suitable TCR sequences for therapy. After confirming safety in the dose escalation stage (Part A), selected patients enter the dose expansion stage (Part B) for further treatment with the established dose. Throughout the study, participants undergo various assessments including tumor tissue collection, blood tests, organ function evaluations, and performance status checks. Safety and tumor response are monitored for about two years. Additional evaluations include HLA typing, TCR sequencing, and regular follow-ups, with careful monitoring of organ functions and adverse events. The trial duration depends on individual patient response and treatment course.
CONDITIONS
Brief Title
Personalized KSX01-TCRT in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and able to complete all testing procedures
- Age between 18 and 70 years old
- Confirmed incurable or metastatic solid tumors that have failed standard treatment
- Expected survival time longer than 6 months
- ECOG performance status of 0 or 1
- Sufficient organ function including blood counts, liver, and kidney function within specified limits
- Positive HLA-I class molecule expression
- Tumor lesions available for collection or recent archived tissue for TCR screening
- Agree to peripheral monocyte collection post testing
- Negative pregnancy test for women of childbearing potential and use of contraceptives
- Male participants agree to use contraceptives and not donate sperm during treatment period
- At least one measurable lesion according to iRECIST or approval for evaluable lesions
- Toxicity from prior treatments resolved to Grade 1 or below (excluding minor effects such as hair loss)
You will not qualify if you...
- Received third-line or higher systemic chemotherapy before enrollment
- History of other malignant tumors within past 2 years except certain low-risk cancers
- Active or uncontrolled liver diseases or hepatitis infections
- Significant heart diseases within 6 months prior to enrollment
- Tumor lesions invading heart or large vessels
- Permanent indwelling tubes unless removable before treatment
- Primary immune deficiency or HIV positive
- Allogeneic stem cell transplant within 6 months
- Prior CAR T cell or genetically modified T cell therapy
- Allergies to study treatment components
- History of autoimmune diseases except stable hypothyroidism or controlled type 1 diabetes
- Conditions impairing understanding or adherence to study
- History of alcohol or drug abuse
- Neurological or psychiatric disorders such as epilepsy or schizophrenia
- Conditions increasing risk or complicating treatment interpretation
- Pregnancy or lactation
- Recent infections or major surgery within specified periods
- Abnormal lung function indicated by specific test results
- Use of systemic corticosteroids or immunosuppressive drugs within 7 days prior to treatment, except allowed exceptions
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 personalized KSX01-TCRT cell therapy, a patient autologous T cell therapy for advanced solid tumors.
Regular visits during treatment as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
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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