Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on TIL for the Treatment of Brain Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04943913
Recruitment Status : Recruiting
First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Collaborator:
Second Affiliated Hospital of Soochow University
Information provided by (Responsible Party):
Shanghai Gencells Therapeutics Co., Ltd.

Brief 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 fludarabine and cyclophosphamide.

Condition or disease Intervention/treatment Phase
Glioma Biological: Tumor Infiltrating Lymphocytes (TIL) Early Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Safety and Efficacy Study on TIL for the Treatment of Glioma
Actual Study Start Date : May 6, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tumor Infiltrating Lymphocytes
1x10^9-3x10^11 in vitro expanded autologous TILs will be infused i.v. to patients with brain glioma after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.
Biological: Tumor Infiltrating Lymphocytes (TIL)
Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.




Primary Outcome Measures :
  1. Safety [ Time Frame: 1 month ]
    Number of Adverse Events related to TIL infusion

  2. Objective Response Rate (ORR) [ Time Frame: Up to 36 months ]
    PET/CT scan will be performed to evaluate the clinical response to TIL infusion in patients as determined by objective response rate (ORR), which contains complete response (CR) and partial response (PR), using the RECIST v1.1, as assessed by the Investigator. ( Except baseline evaluation within 28 days before TIL infusion,PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 1 year, and then every six months after that for up to 3 years)

  3. Disease Control Rate (DCR) [ Time Frame: Up to 36 months ]
    Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1

  4. Duration of Response (DOR) [ Time Frame: Up to 36 months ]
    The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

  5. Progression-Free Survival (PFS) [ Time Frame: Up to 36 months ]
    The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

  6. Overall Survival (OS) [ Time Frame: Up to 36 months ]
    The length of time from the date of the start of TIL treatment that the patients are still alive


Secondary Outcome Measures :
  1. Complete Response(CR) [ Time Frame: Up to 36 months ]
    Patients with complete response per RECIST 1.1 to TIL treatment

  2. Partial Response (PR) [ Time Frame: Up to 36 months ]
    Percentage of patients with partial response per RECIST 1.1 to TIL treatment

  3. Stable Disease (SD) [ Time Frame: Up to 36 months ]
    Patients with stable disease per RECIST 1.1 to TIL treatment

  4. Progressive Disease (PD) [ Time Frame: Up to 36 months ]
    Patients with progressive disease per RECIST 1.1 to TIL treatment

  5. Change in Quality of Life [ Time Frame: Up to 36 months ]
    Comparison of patients' quality of life before and after TIL treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Absolute count of white blood cells≥2.5×10^9/L, absolute count of neutropils≥1.5×10^9/L, platelet count≥100×10^9, hemoglobin≥90 g/L;
  9. Serum creatinine clearance 50mL/min or higher; creatinine≤1.5×ULN; ALT/AST less than three times that of normal group, ALT/AST of test subjects with liver metastasis less than five times that of normal group; bilirubin≤1.5×ULN; Activated partial thromboplastin time (APTT) less than or equal to 1.5xULN; international normalized ratio (INR) less than or equal to 1.5xULN;
  10. Enough venous accessibility, no absolute or relative contraindications to operation or biopsy;
  11. 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;
  12. Any malignant tumor-targeting therapies, including radiotherapy, 13.chemotherapy and biologics must cease 28 days before obtaining TILs;

14.Be able to understand and sign the informed consent document; 15.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);
  2. Autoimmune diseases requiring immunomodulatory treatment;
  3. Serum creatinine >1.5×ULN; serum glutamic-oxalacetic transaminase (SGOT) greater than 5×ULN; bilirubin >1.5×ULN;
  4. Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
  5. 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.
  6. 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;
  7. Severe physical or mental diseases;
  8. Blood culture positive or imaging proof;
  9. Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
  10. History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
  11. Having received immunotherapy and developed irAE level greater than Level 3;
  12. 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);
  13. Females in pregnancy or lactation;
  14. Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04943913


Contacts
Layout table for location contacts
Contact: Feng Pan +86 21 69110327 pan-f@gencells.cn

Locations
Layout table for location information
China, Jiangsu
The Second Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China
Contact: Lan Qing    +86 0512 67784089    szlq006@163.com   
Sponsors and Collaborators
Shanghai Gencells Therapeutics Co., Ltd.
Second Affiliated Hospital of Soochow University
Investigators
Layout table for investigator information
Principal Investigator: Qing Lan Second Affiliated Hospital of Soochow University
Layout table for additonal information
Responsible Party: Shanghai Gencells Therapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT04943913    
Other Study ID Numbers: GC101-JD-LK
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue