Actively Recruiting
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
264 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.
CONDITIONS
Official Title
Personalized KSX01-TCRT in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who understand and consent to participate in the study
- Aged 18 to 70 years old
- Histologically or cytologically confirmed incurable or metastatic solid tumors with no effective standard treatment
- Expected survival time longer than 6 months
- ECOG performance status of 0 or 1
- Adequate organ function including specified blood counts, liver and kidney function
- Positive HLA-I class molecule expression by immunohistochemistry
- Available tumor lesions for tissue collection and TCR sequence screening
- Agreement to peripheral monocyte collection after screening
- Negative pregnancy test for women of childbearing potential and use of contraception
- Male participants agree to use contraception and avoid sperm donation during study
- At least one measurable lesion by iRECIST or evaluable lesions with serum markers
- Toxicities from prior treatments resolved to Grade 1 except for insignificant effects such as hair loss
You will not qualify if you...
- Prior systemic chemotherapy at third line or beyond
- History of other malignant tumors within 2 years except certain low-risk cancers
- Active liver diseases including hepatitis B or C infection unless well controlled
- Recent significant heart diseases or unstable cardiac conditions
- Tumor invading heart or large blood vessels or presence of permanent indwelling tubes
- Primary immune deficiency or HIV positive status
- Prior allogeneic stem cell transplant within 6 months
- Previous genetically modified T cell therapies other than the study treatment
- Known allergy to study drug components
- History of autoimmune diseases except stable hypothyroidism or controlled type 1 diabetes
- Cognitive or psychiatric conditions impairing participation
- Alcohol or substance abuse history
- Abnormal lung function with FEV1/FVC ratio below 70%
- Recent severe infections or major surgery within study period
- Use of systemic corticosteroids or immunosuppressants within 7 days prior to monotherapy except specific exceptions
- Active CNS tumors or symptomatic brain metastases except under specified stable conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
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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