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Trial Title:
TIL for Patients With Advanced Solid Tumor
NCT ID:
NCT06334783
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Autologous tumor-infiltrating lymphocyte cells
Description:
On day 0, all patients will receive autologous tumor-infiltrating lymphocyte cells
administered.
Arm group label:
TILs
Summary:
Background:
Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by
harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro
and then infusing back to patients.
TIL therapy has shown strong efficacy for the treatment of solid tumors and has achieved
high objective response rates in multiple cancers, such as melanoma, NSCLC, and cervical
cancer.
Objective:
To evaluate the safety and efficacy of TIL for the patients with advanced solid tumor.
Eligibility:
Adults aging 18-75 with advanced solid tumor.
Design:
1. Patients will undergo screening tests, including imaging procedures, heart and lung
tests, and lab tests.
2. Freshly resected patient tumors were dissected by the surgeon.
3. TIL cells were isolated from the patient's tumor tissue, then cultured in vitro,
activated and expanded.
4. At last TIL cells will be re-infused into the patients.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. Be able to understand and sign the Informed of Consent Document. Be willing to
follow the procedure and protocol of the clinical trial.
2. Age ≥ 18 years and ≤ 75 years.
3. Expected survival time > 3 months.
4. ECOG score 0-1.
5. At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for
TIL preparation.
6. At least 1 measurable lesion (according to RECIST v1.1).
7. Metastatic or recurrent solid tumor, confirmed by histopathology. Patients who have
failed previous standard treatment or currently do not have standard treatment, or
who have been determined by the researcher to be unsuitable for current standard
treatment due to other reasons.
8. Any previous anti-tumor treatment must exceed 28 days when collecting tumor tissue;
The tumor tissue used for collecting and preparing TIL should not have undergone
local treatment.
9. The bone marrow function of the subject's meets the following requirements:
1. Absolute neutrophil count (ANC) ≥ 1.5× 10e9/L.
2. Platelet (PLT) ≥ 75× 10e9/L.
3. Hemoglobin (HGB) ≥ 90 g/L.
10. Liver and kidney function:
1. Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine
clearance ≥ 60 ml/min.
2. Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤
2.5 times of ULN.
3. Total bilirubin (TBIL) ≤ 1.5 times of ULN.
11. Blood coagulation function:
1. Prothrombin time (PT) ≤ 1.5 ULN.
2. International Normalized Ratio (INR) ≤ 1.5 ULN.
3. or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
12. Left Ventricular Ejection Fractions (LVEF)≥45%.
13. Forced Expiratory Volume in the first second (FEV1)≥50%.
14. Women or men of childbearing potential should be ascetic or take contraception since
the signing of ICF to 24 weeks or later after the last administration of drug.
Exclusion criteria:
1. Female subjects who are in pregnancy or lactation or have a positive baseline blood
pregnancy test.
2. Individuals who have experienced severe allergic reactions to any drug or its
components in this trial in the past.
3. Received any investigational medication within 28 days prior to TIL cell transfusion
or participated in another clinical study at the same time.
4. History of other known malignant tumors within the previous 5 years.
5. Primary central nerve system (CNS) cancer, or Participants with CNS metastasis after
localized treatment.
6. History or syndrome of autoimmune diseases.
7. History of immunodeficiency, including testing positive for Human Immunodeficiency
Virus (HIV), or having other acquired or congenital immunodeficiency diseases.
8. Have a history of ≥ grade 3 thromboembolic events within the past 6 months or are
currently receiving thrombolytic or anticoagulant treatment due to high risk of
thrombosis.
9. History of hereditary or acquired hemorrhagic diseases.
10. Clinical cardiovascular diseases or symptoms.
11. Active infection present.
12. Active pulmonary tuberculosis infection.
13. positive hepatitis B surface antigen or positive hepatitis B core antibody or
positive hepatitis C virus antibody.
14. Syphilis spirochete antibody positive.
15. Patients received major surgery or under severe injury within 28 days before TIL
infusion.
16. Patients who received live vaccine or attenuated live vaccine 28 days before TIL
infusion.
17. Patients who have drug addiction history, alcoholism, or drug users.
18. Patients who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.)
19. Patients not suitable for the clinical trial evaluated by the investigators.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiugui Sheng, PhD
Email:
hanxiuchen@yeah.net
Facility:
Name:
Nanjing Jinling Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tangfeng Lv, PhD
Phone:
+86 25 8086 0114
Email:
bairoushui@163.com
Facility:
Name:
Wowen's hospital, School of medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Wang, PhD
Email:
5198008@zju.edu.cn
Start date:
May 30, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Hervor Therapeutics
Agency class:
Industry
Collaborator:
Agency:
Jinling Hospital, China
Agency class:
Other
Collaborator:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Source:
Hervor Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06334783