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Advanced Non-Small Cell Lung CancerPhase 1NCT07105176

HS-IT101 Injection for Advanced NSCLC(FASTIL-Lung01)

A Phase 1 study testing Cyclophosphamide, Fludarabine and IL-2 (interleukin 2) in people with Advanced Non-Small Cell Lung Cancer, run by Hangzhou Huasai Biomedicine Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Cyclophosphamide, Fludarabine and IL-2 (interleukin 2)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
30 Aug 2026to 30 Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • Age: 18 to 75 years old;
  • Patients with advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) who have been confirmed by cytology or histology and have failed at least one line of standard first-line therapy. Patients with non-squamous NSCLC who are negative for EGFR/ALK/ROS1 driver mutations.
  • There must be at least one tumor lesion that has not undergone radiation therapy or other local treatments within the past 28 days, which will be used to prepare autologous tumor-infiltrating lymphocytes, and it must meet the tissue sampling requirements.
  • After sampling, there must be at least one measurable lesion that meets the RECIST 1.1 criteria definition, and this lesion has not undergone radiotherapy or other local treatments;
  • ECOG score ≤ 1;
  • The expected survival time is ≥ 3 months;
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  • During the screening period, the assessments showed adequate organ and bone marrow function,
  • Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%; no arrhythmias requiring treatment; QT interval corrected by the Fridericia method (QTcF) ≤470 ms; baseline blood oxygen saturation >91% in ambient air conditions;
  • Prior to tumor sampling, adverse reactions induced by previous treatments have recovered to Grade 1 (5.0) or below according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0;
  • From the signing of the informed consent form to one year after TIL cell infusion, agree to adopt effective non-pharmacological contraception measures;
  • Those who fully understand this trial and voluntarily sign the informed consent form, and are able to comply with the visits and related procedures stipulated in the protocol.

Who cannot join

  • Patients who have previously experienced severe allergic reactions to drugs used during the research process;
  • Presence of any uncontrolled clinical conditions, including but not limited to: poorly controlled hypertension; congestive heart failure;
  • Within the past 6 months, the following conditions have occurred: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
  • Autoimmune diseases that are active and require systemic treatment during the study period;
  • Organ transplantation or a history of hematopoietic stem cell transplantation;
  • Within 4 weeks prior to tumor tissue sampling, the subject has used any immunosuppressive drugs, such as steroid medications, or the investigator determines that there are comorbid conditions requiring the use of immunosuppressive drugs during the trial. However, physiological doses of glucocorticoids are permitted, and intranasal or local use of steroid medications is allowed;
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  • Individuals who have received systemic anti-tumor treatment within the 4 weeks prior to pre-treatment or those planning to participate in other interventional clinical trials during the study period;
  • Presence of acute or chronic infections, active infections requiring systemic treatment, or active tuberculosis infection;
  • Individuals who have undergone major organ surgery or suffered significant trauma within the past 4 weeks, or who require elective surgery during the trial period;
  • Patients with pre-selection surgical complications or delayed healing, and those judged by the researcher to be at increased risk for lymph node clearance pretreatment, adoptive TIL therapy, and IL-2 adjuvant therapy;
  • Within the 5 years prior to screening, diagnosed with concurrent other primary malignant tumors, excluding completely resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or in situ carcinoma that has undergone radical excision;
  • Suffering from severe respiratory diseases;
  • Patients with gastrointestinal bleeding requiring surgical treatment, or those with localized intestinal ischemia or perforation;
  • Patients with known leptomeningeal metastasis; patients with other central nervous system metastases that are not effectively controlled by treatment or have not been treated;
  • Has previously received similar cell therapy products;
  • Pregnant or lactating women;
  • Individuals with known mental illnesses, alcoholism, drug or substance abuse, or those deemed unsuitable by other researchers to participate in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

WenNa.Liu contact

（86）400-6786-208

med@sino-cellbiomed.com

China1 site, 1 recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    YiLong Wu, 86-020-83525173, gdghospital_ec@gdph.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Single-arm Clinical Study of HS-IT101 Injection for Advanced NSCLC

An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.

Read the detailed description

A Single-Arm, Open-Label, Interventional Study Evaluating Adoptive Cell Therapy (ACT) with Autologous Tumor-Infiltrating Lymphocytes (HS-IT101) Following Lymphodepleting Conditioning with Fludarabine and Cyclophosphamide, Followed by IL-2 in Patients with Advanced NSCLC.

Being tested
Cyclophosphamide, Fludarabine, IL-2 (interleukin 2)

What participants receive

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

  • CyclophosphamideDrug

    Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.

  • FludarabineDrug

    Fludarabine is administered once daily via intravenous infusion for 3 consecutive days.

  • IL-2 (interleukin 2)Drug

    IL-2 is administered subcutaneously or intravenously once daily. The dose may be adjusted based on the subject's tolerance, including modifications to the dose, dosing frequency, or complete discontinuation of treatment, Up to three administrations.

Study groups in NCT07105176
Study groupRoleWhat they receive
HS-IT101 monotherapyExperimentalTIL Injection administered by intravenous infusion over 30-60 minutes.
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2 (interleukin 2)

What is being measured

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

  1. Adverse Events (AE)

    To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of adverse events

    Measured: 12 months

  2. Serious Adverse Events (SAE)

    To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of serious adverse events

    Measured: 12 months

  3. Objective Response Rate (ORR)

    To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor, based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1

    Measured: Up to 36 months

  4. Time-to-response (TTR)

    To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor by assessing the time-to-response (TTR) as assessed by the Investigator per RECIST v1.1

    Measured: Up to 36 months

  5. Duration of Response (DOR)

    To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor by assessing the duration of response (DOR) as assessed by the Investigator per RECIST v1.1

    Measured: Up to 36 months

  6. Disease Control Rate (DCR)

    To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor, based on the disease control rate (DCR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1

    Measured: Up to 36 months

Secondary outcomes (4)

  1. Progression-Free-Survival (PFS)

    To evaluate progression-free-survival (PFS) in patients with advanced solid tumor

    Measured: Up to 36 months

  2. Overall Survival (OS)

    To evaluate overall survival (OS) in patients with advanced solid tumor

    Measured: Up to 36 months

  3. Pharmacokinetic (PK) detection parameters for HS-IT101

    peripheral blood lymphocyte subsets .

    Measured: Up to 6 months

  4. Pharmacokinetic (PK) detection parameters for HS-IT101

    T-cell receptor (TCR) clonality

    Measured: Up to 6 months

Timeline

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

  1. First posted5 Aug 2025
  2. Study start30 Aug 2026
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2028 (estimated)

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
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105176
Sponsor's protocol ID
HS-IT101ST01-Ⅰ b-02
Status last verified
Jul 2026
First submitted
22 Jul 2025
Last updated
14 Oct 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 Cyclophosphamide, Fludarabine and IL-2 (interleukin 2) in people with Advanced Non-Small Cell Lung Cancer, run by Hangzhou Huasai Biomedicine Co., Ltd. at 1 site 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 11 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact WenNa.Liu (（86）400-6786-208, med@sino-cellbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AE) (time frame: 12 months). The study lists 6 primary outcomes in all. 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 NCT07105176.

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 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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