Actively Recruiting
KSH01-R02-101 Solid Tumors
Led by TCRx Therapeutics Co.Ltd · Updated on 2023-04-03
50
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. . safety and tolerance 2. . objective response rate
CONDITIONS
Official Title
KSH01-R02-101 Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent and ability to complete all procedures
- Male or female aged 18 to 70 years inclusive
- Malignant solid tumors that failed standard treatments
- Positive for HLA-A *02 and tumor target positive with more than 30% of cancer cells showing 2+ or 3+ staining
- Previous anti-tumor treatment toxicities resolved to grade 0-1 or acceptable level
- Adequate organ function with specific blood counts, liver, kidney, and coagulation parameters within defined limits
- ECOG performance status 0-1
- Expected survival time of at least 12 weeks
- At least one measurable or evaluable lesion per RECIST 1.1
- Sufficient PBMC cells collected for autologous TCR-T cell preparation
- Autologous TCR-T cells prepared in adequate quantity and quality for reinfusion
- Female subjects of childbearing potential must have a negative pregnancy test within 3 days before transfusion and agree to effective contraception or abstinence for 6 months
- Male subjects must agree to effective contraception or abstinence for 6 months and not donate sperm during this time
- Provision of tumor tissue samples suitable for target analysis, either archived or fresh biopsy (excluding bone biopsy) with positive target expression
You will not qualify if you...
- History of serious allergic reactions or known allergy to study drugs or components
- Previous coronary artery reconstruction
- Major bleeding disorders or recent thrombosis/embolism
- Recent clinically significant hemoptysis or tumor hemorrhage
- Recent anticoagulant or antiplatelet therapy beyond allowed limits
- Unhealed wounds, recent live vaccine, or recent prohibited anti-tumor treatments
- Recent corticosteroid use beyond permitted cases
- Leptomeningeal metastasis or uncontrolled/symptomatic CNS metastasis
- Primary immunodeficiency or active autoimmune disease requiring intervention
- Severe cardiac events or conditions within 6 months prior
- Uncontrolled pleural, pericardial, or peritoneal effusions
- Specific cardiac abnormalities or poor lung function
- Fever of unknown cause above 38.5°C during screening
- History of allograft transplantation
- Known substance abuse history
- History of significant neurological or psychiatric disorders
- Known AIDS diagnosis
- Serious active infections or positive viral serologies (HIV, CMV, HSV, HPV, EBV, syphilis)
- Hepatitis B or C with active viral replication
- Investigator judgment of increased risk or confounding toxicities
- Expectation to receive other anti-tumor treatments during the study
- Pregnant or lactating women
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, China, 100000
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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