Actively Recruiting
Evaluation of Tumor Infiltrating Lymphocyte Therapy for Adults with Advanced Solid Tumors
Led by Shanghai Juncell Therapeutics · Updated on 2026-08-05
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Sir Run Run Shaw Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte TIL therapy in adults with advanced solid tumors. This early-phase study involves patients who have either relapsed, metastasized, or have primary solid tumors and have failed standard treatments or have no standard options available. The study focuses on patients with measurable tumors and a life expectancy of more than three months. Participants receive an infusion of their own expanded TILs, ranging from 1 billion to 50 billion cells, administered intravenously over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion treatment with hydroxychloroquine a single 600 mg dose and cyclophosphamide. The therapy is given after tumor tissue or malignant fluid is collected for TIL expansion. Throughout the study, participants are closely monitored for adverse events over six months and assessed for tumor response, disease control, duration of response, progression-free survival, and overall survival for up to 36 months. Quality of life changes are also evaluated during this period. Participants must adhere to follow-up visits and assessments to track treatment effects and safety over time.
CONDITIONS
Brief Title
A Clinical Study on TIL for the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years
- Histologically confirmed primary, relapsed, or metastatic solid tumors
- Life expectancy longer than 3 months
- Karnofsky score of 60% or higher, or ECOG score between 0 and 2
- Failed standard treatments or no standard treatments available
- Presence of tumor regions suitable for biopsy or resection, or malignant fluid for TIL isolation
- At least one measurable tumor lesion
- Adequate blood counts and organ function within 7 days before enrollment
- No contraindications to surgery or biopsy
- Use of approved effective contraception during consent and for 1 year after lymphodepletion
- Cessation of any tumor-targeting therapies at least 28 days before TIL collection
- Ability to understand and sign informed consent
- Commitment to follow-up visit plans and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment with daily prednisone dose over 15 mg or immunomodulatory treatment for autoimmune diseases
- Forced expiratory volume in 1 second less than 2 liters or lung diffusing capacity less than 40%
- Severe heart conditions including NYHA Grade III or IV heart failure, low blood pressure, or ejection fraction less than 35%
- Severe cardiac rhythm or conduction problems requiring intervention
- Positive for HIV, active hepatitis B or C, syphilis, or Treponema pallidum antibodies
- Severe physical or mental illness
- Active systemic infections requiring treatment or positive blood cultures
- Receiving other medicines, biologic therapy, chemotherapy, or radiotherapy within the past month or currently
- Allergies to chemical or biologic substances similar to cell therapy
- History of immunotherapy-related adverse events above level 3
- Previous anti-tumor treatment adverse events not resolved to grade 1 or below (except alopecia)
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation or kidney replacement therapy
- Other severe systemic diseases or reasons making participation inappropriate
Research Team
C
Clinical GC
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