Actively Recruiting
Immunotherapy for the Treatment of Advanced Solid Tumor
Led by Tongji Hospital · Updated on 2024-08-13
40
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.
CONDITIONS
Official Title
Immunotherapy for the Treatment of Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years at time of consent
- Have recurrent, metastatic, or persistent carcinoma not treatable with surgery or radiation and no other expected beneficial therapies
- Have at least one lesion suitable for surgical removal to generate TIL, with tumor tissue at least 1.5 cm in diameter
- Have measurable target lesion remaining after tumor resection
- Have progressive disease during or after most recent prior treatment
- Discontinued prior cancer therapies at least 28 days before tumor resection
- ECOG performance status of 0 or 1
- Negative for human immunodeficiency virus (HIV)
- If positive for hepatitis B or C markers, must have undetectable viral load with or without treatment
- Adequate blood counts: neutrophils >1000/mm3 without filgrastim support, WBC ≥3000/mm3, platelets ≥100,000/mm3, hemoglobin >8.0 g/dl
- Adequate liver and kidney function: ALT/AST ≤2.5 times upper limit of normal, creatinine ≤1.6 mg/dl, bilirubin ≤1.5 mg/dl (or ≤3.0 mg/dl if Gilbert's Syndrome)
- Women of childbearing potential must have a negative pregnancy test
You will not qualify if you...
- Prior organ transplant or prior cell transfer therapy
- Current systemic steroid therapy >10 mg prednisone daily or equivalent
- Therapy-related toxicities greater than Grade 1 except peripheral neuropathy, alopecia, or vitiligo
- Allergy or hypersensitivity to TIL therapy components or study drugs
- Active systemic infections, coagulation disorders, or major illnesses affecting heart, lungs, or immune system
- Untreated or symptomatic brain metastases
- Primary or acquired immunodeficiency syndromes including AIDS
- End-stage renal disease requiring dialysis
- Left ventricular ejection fraction <45% or NYHA Class 2 or higher heart failure
- Forced expiratory volume in 1 second (FEV1) ≤60% predicted
- Received live or attenuated vaccine within 28 days before preparative regimen
- Cancer requiring immediate treatment or that would be disadvantaged by study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
H
Hui Wang, MD
CONTACT
Z
Zhiyong Huang, MD
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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