Using tumor-infiltrating lymphocytes to treat advanced solid tumors

Tumor Infiltrating Lymphocyte (TIL) Therapy for the Treatment of Advanced Solid Tumors

This study is testing a new treatment that uses immune cells taken from a patient's own tumor to see if it can help people with advanced solid tumors who haven't responded to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hervor Therapeutics (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 3 sites (Shenzhen, Guangdong and 2 other locations)
• Trial ID: NCT06334783 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of tumor-infiltrating lymphocyte (TIL) therapy for patients with advanced solid tumors. The approach involves harvesting lymphocytes from the patient's tumor, culturing and amplifying them in a laboratory, and then reinfusing them back into the patient. Eligible participants will undergo screening tests to ensure they meet the criteria, and the trial aims to assess the therapeutic potential of this innovative cellular therapy. The study focuses on patients who have not responded to standard treatments or are unsuitable for them.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced solid tumors that have not responded to standard treatments.

Not a fit: Patients with early-stage tumors or those who are currently receiving effective standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: Previous studies have shown promising results for TIL therapy in various solid tumors, indicating a potential for success in this approach.

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.

Where this trial is running

Shenzhen, Guangdong and 2 other locations

• Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center — Shenzhen, Guangdong, China (Recruiting)
• Nanjing Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)
• Wowen's hospital, School of medicine, Zhejiang University — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Tangfeng Lv, PhD

Conditions Advanced Solid Tumor