Actively Recruiting
Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors
Led by Peking University · Updated on 2025-08-24
10
Participants Needed
2
Research Sites
165 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
Y
Yingkai Saiwei（Beijing）Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.
CONDITIONS
Official Title
Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Willing and able to give informed consent
- HLA-A*11:01 positive
- Tumor samples testing positive for MAGE-A4 (at least 30% positive cells)
- Diagnosed with recurrent or metastatic advanced solid tumors that failed or are intolerant to standard treatments
- At least one measurable tumor lesion per RECIST 1.1
- No systemic anti-tumor therapy within 2 weeks before blood collection
- ECOG performance status of 0 or 1 and expected survival of 3 months or more
- Blood oxygen saturation of 95% or higher without oxygen
- Acceptable blood counts and chemistry, including neutrophils, lymphocytes, platelets, hemoglobin, kidney and liver function
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception for at least 1 year after last treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV, syphilis, or hepatitis C virus
- Uncontrolled active infections including active tuberculosis or hepatitis B
- Symptomatic brain metastases
- Unresolved adverse events from prior treatments except for hair loss or mild lab abnormalities
- Allergies to study drugs or treatment components, including fludarabine, cyclophosphamide, or penicillin
- History of coronary artery reconstruction
- Tumor lesions invading large blood vessels with high bleeding risk
- Blood clots within 6 months before treatment
- Major surgery or severe trauma within 4 weeks before blood collection
- History or pending organ transplantation
- Serious uncontrolled medical conditions such as poorly controlled diabetes, hypertension, heart failure, heart attack, arrhythmia, lung disease, or abnormal lung function
- Expected to require immunosuppressive therapy during the study (except low-dose steroids)
- Long-term use of aspirin or blood thinners
- Participation in other clinical trials within 2 weeks
- Drug addiction or history of drug abuse
- Unable or unwilling to follow study protocol as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of GI Oncology, Peking University Cancer Hospital Recruiting Beijing, Beijing, China, 100142
Beijing, China
Not Yet Recruiting
2
Peking University Cancer Hospital & Institute
Beijing, China
Actively Recruiting
Research Team
L
Lin Shen
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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