TIL for Patients With Advanced Solid Tumor

NCT06334783 | Terminated Phase 1

• 1 other identifier: HV-IIT
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief 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. 1.Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests.
2. 2.Freshly resected patient tumors were dissected by the surgeon.
3. 3.TIL cells were isolated from the patient's tumor tissue, then cultured in vitro, activated and expanded.
4. 4.At last TIL cells will be re-infused into the patients.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Safety of TIL

  The safety of TIL will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase.

  Day 0 - Day 730

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  Day 0 - Day 730

• Duration of Response (DOR)

  Day 0 - Day 730

• Disease Control Rate (DCR)

  Day 0 - Day 730

• Progression free survival (PFS)

  Day 0 - Day 730

• Overall survival (OS)

  Day 0 - Day 730

Study Arms (1)

TILs

EXPERIMENTAL

Biological: TILs Drug: IL-2

Biological: Autologous tumor-infiltrating lymphocyte cells

Interventions

Autologous tumor-infiltrating lymphocyte cells BIOLOGICAL

On day 0, all patients will receive autologous tumor-infiltrating lymphocyte cells administered.

TILs

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
• Age ≥ 18 years and ≤ 75 years.
• Expected survival time \> 3 months.
• ECOG score 0-1.
• At least one lesion that could undergo surgery or biopsy to obtain tumor tissue for TIL preparation.
• At least 1 measurable lesion (according to RECIST v1.1).
• 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.
• 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.
• The bone marrow function of the subject's meets the following requirements:
• Absolute neutrophil count (ANC) ≥ 1.5× 10e9/L.
• Platelet (PLT） ≥ 75× 10e9/L.
• Hemoglobin (HGB) ≥ 90 g/L.
• Liver and kidney function:
• Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min.
• Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of ULN.

You may not qualify if:

• Female subjects who are in pregnancy or lactation or have a positive baseline blood pregnancy test.
• Individuals who have experienced severe allergic reactions to any drug or its components in this trial in the past.
• Received any investigational medication within 28 days prior to TIL cell transfusion or participated in another clinical study at the same time.
• History of other known malignant tumors within the previous 5 years.
• Primary central nerve system (CNS) cancer, or Participants with CNS metastasis after localized treatment.
• History or syndrome of autoimmune diseases.
• History of immunodeficiency, including testing positive for Human Immunodeficiency Virus (HIV), or having other acquired or congenital immunodeficiency diseases.
• 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.
• History of hereditary or acquired hemorrhagic diseases.
• Clinical cardiovascular diseases or symptoms.
• Active infection present.
• Active pulmonary tuberculosis infection.
• positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody.
• Syphilis spirochete antibody positive.
• Patients received major surgery or under severe injury within 28 days before TIL infusion.

Sponsors & Collaborators

• Jinling Hospital, China: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator
• Hervor Therapeutics: lead
• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center: collaborator

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, Guangdong, China

Location

Nanjing Jinling Hospital

Nanjing, Jiangsu, 210000, China

Location

Wowen's hospital, School of medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: May 30, 2023
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)