Study on TIL for the Treatment of Brain Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria. 1. Age: 18 years to 75 years; 2. Histologically diagnosed as primary/relapsed/metastasized brain glioma; 3. Expected life-span more than 3 months; 4. Karnofsky≥60% or ECOG score 0-2; 5. Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. 6. Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated; 7. At least 1 evaluable tumor lesion; 8. 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; 9.
No absolute or relative contraindications to operation or biopsy; 10. 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; 11. Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs; 12. Be able to understand and sign the informed consent document; 13. Be able to stick to follow-up visit plan and other requirements in the agreement.

Exclusion Criteria:

1. Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment; 2. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%; 3. Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc. 4. Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive; 5. Severe physical or mental diseases; 6. Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection); 7. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy; 8. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy; 9. Having received immunotherapy and developed irAE level greater than Level 3; 10. Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded); 11. Females in pregnancy or lactation; 12. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy; 13. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04943913
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Shanghai Juncell Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Qing Lan
Principal Investigator Affiliation Second Affiliated Hospital of Soochow University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioma
Arms & Interventions

Arms

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.

Interventions

Biological: - Tumor Infiltrating Lymphocytes (TIL)

Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Suzhou, Jiangsu, China

Status

Recruiting

Address

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu,

Site Contact

Lan Qing

[email protected]

+86 0512 67784089

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