A Clinical Safety and Efficacy Study on TIL for the Treatment of Glioma

Who is this study for? Patients with Glioma
What treatments are being studied? Tumor Infiltrating Lymphocytes (TIL)
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age: 18 years to 75 years;

• Histologically diagnosed as primary/relapsed/metastasized brain glioma;

• Expected life-span more than 3 months;

• Karnofsky≥60% or ECOG score 0-2;

• Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.

• Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;

• At least 1 evaluable tumor lesion;

• Hematology and Chemistry(within 7 days prior to enrollment):

‣ Absolute count of white blood cells≥2.5×10\^9/L;

⁃ Absolute count of neutropils≥1.5×10\^9/L;

⁃ Absolute count of lymphocytes ≥0.7×109/L;

⁃ Platelet count≥100×10\^9;

⁃ hemoglobin≥90 g/L;

⁃ Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);

⁃ International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days);

⁃ Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min;

⁃ Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN);

⁃ Totol bilirubin≤1.5×ULN;

• No absolute or relative contraindications to operation or biopsy;

⁃ Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion;

⁃ Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;

⁃ Be able to understand and sign the informed consent document;

⁃ Be able to stick to follow-up visit plan and other requirements in the agreement.

Locations
Other Locations
China
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
GC Clinical
clinicaltrials@juncell.com
086-18001759113
Time Frame
Start Date: 2021-05-06
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 50
Treatments
Experimental: Tumor Infiltrating Lymphocytes
1x10\^9-5x10\^10 in vitro expanded autologous TILs will be infused i.v. to patients with brain glioma after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Juncell Therapeutics
Collaborators: Second Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov