Actively Recruiting
Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
364 weeks
Total Duration
On this page
Sponsors
G
Guangzhou FineImmune Biotechnology Co., LTD.
Lead Sponsor
S
Sun Yat-Sen University Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor . The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .
CONDITIONS
Official Title
Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years old, regardless of gender
- Diagnosed with solid tumors confirmed by histopathology, with detectable or evaluable tumor lesions
- Completed standard treatment or lack effective treatment options
- Willing to participate and sign informed consent
- Physical status ECOG score 0-1
- Expected survival time greater than 3 months
- Negative for HIV antibody, hepatitis B surface antigen, and hepatitis C antibody
- Normal blood routine and coagulation tests; lymphocyte count greater than 0.8 x 10^9/L; hemoglobin over 100 g/L
- Negative pregnancy test for women with fertility potential
- Left ventricular ejection fraction of at least 50% by cardiac ultrasound
- Serum ALT/AST less than 2.5 times the upper normal level; serum creatinine below 1.6 mg/dL; total bilirubin less than 1.5 mg/dL (less than 3 mg/dL for Gilbert's Syndrome)
- At least 4 weeks since last systemic treatment with toxicity resolved to grade 1 or lower (except alopecia or vitiligo)
- Minor surgery allowed within 3 weeks prior if toxicity resolved to grade 1 or lower
- Ability to attend regular visits for detection, evaluation, and management throughout the study
- No anti-tumor drugs or treatments used for 4 weeks before TCR-T cell infusion
- Tumor lesions available for surgery or biopsy with successful isolation of tumor-infiltrating T cells
- Peripheral blood T cells able to proliferate and expand at least 10 times in pre-culture
- Benefits of participation outweigh risks as evaluated by researchers based on patient status
You will not qualify if you...
- Presence of any primary immunodeficiency disease (e.g., severe combined immunodeficiency)
- Moderate to severe infection or possible opportunistic infection
- History of autoimmune diseases such as SLE or psoriasis
- Acute systemic infection, coagulation disorders, or serious heart/lung diseases
- Use of large doses of glucocorticoids or other immunosuppressive agents within 4 weeks
- Allergy to any drugs used in this study
- Central nervous system metastases with clinical instability or acute meningitis (except clinically stable patients meeting specific criteria)
- Pregnant or breastfeeding women
- Patients unable or unwilling to use contraception during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China, 510700
Actively Recruiting
Research Team
X
Xuzhi Pan
CONTACT
H
Haiping Liu
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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