AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT06334783

TIL for Patients With Advanced Solid Tumor

A Phase 1 study testing Autologous tumor-infiltrating lymphocyte cells in people with Advanced Solid Tumor, run by Hervor Therapeutics at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
Autologous tumor-infiltrating lymphocyte cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
3 sitesChina
Study dates
30 May 2023to 31 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 23Show fewer
  • 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.
  • Total bilirubin (TBIL) ≤ 1.5 times of ULN.
  • Blood coagulation function:
  • Prothrombin time (PT) ≤ 1.5 ULN.
  • International Normalized Ratio (INR) ≤ 1.5 ULN.
  • or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
  • Left Ventricular Ejection Fractions (LVEF）≥45%.
  • Forced Expiratory Volume in the first second (FEV1）≥50%.
  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • Patients who received live vaccine or attenuated live vaccine 28 days before TIL infusion.
  • Patients who have drug addiction history, alcoholism, or drug users.
  • Patients who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.)
  • Patients not suitable for the clinical trial evaluated by the investigators.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Wowen's hospital, School of medicine, Zhejiang University

    Hangzhou, Zhejiang

  • Nanjing Jinling Hospital

    Nanjing, Jiangsu, 210000

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong

Other trials in China

About this study

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

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.

Read more

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.
Being tested
Autologous tumor-infiltrating lymphocyte cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous tumor-infiltrating lymphocyte cellsBiological

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

Study groups in NCT06334783
Study groupRoleWhat they receive
TILsExperimentalBiological: TILs Drug: IL-2
Receives: Biological: Autologous tumor-infiltrating lymphocyte cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 - Day 730

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 and iRECIST as assessed by the investigator.

    Measured: Day 0 - Day 730

  2. Duration of Response (DOR)

    To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 and iRECIST as assessed by the investigator until disease progression or death due to any cause.

    Measured: Day 0 - Day 730

  3. Disease Control Rate (DCR)

    To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 and iRECIST as assessed by the investigator.

    Measured: Day 0 - Day 730

  4. Progression free survival (PFS)

    To evaluate the time from the date of TIL infusion until disease progression per RECIST v1.1 and iRECIST as assessed by the investigator or death due to any cause.

    Measured: Day 0 - Day 730

  5. Overall survival (OS)

    To evaluate the time from the date of TIL infusion to death due to any cause.

    Measured: Day 0 - Day 730

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start30 May 2023
  3. Primary completion31 Jan 2025
  4. Study completion31 Jul 2025

Why it stopped: Portfolio prioritization

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334783
Sponsor's protocol ID
HV-IIT
Status last verified
Jan 2026
First submitted
21 Mar 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous tumor-infiltrating lymphocyte cells in people with Advanced Solid Tumor, run by Hervor Therapeutics at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Portfolio prioritization). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of TIL (time frame: Day 0 - Day 730). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334783.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in