Advanced NSCLCPhase 1NCT07830342
A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer(FASTIL-Lung02)
A Phase 1 study testing Cyclophosphamid, Fludarabine and Interleukin 2 subcutaneous injection in people with Advanced NSCLC, run by Hangzhou Huasai Biomedicine Co., Ltd. at 1 site in China.
Trial summary
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced NSCLC
- What is being tested?
- Cyclophosphamid, Fludarabine and Interleukin 2 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2026to Oct 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;
- Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;
- At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and/or biopsied for the preparation of autologous tumor-infiltrating lymphocytes;
- After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
- ECOG performance status ≤ 1;
- Adequate organ and bone marrow function as assessed during the screening period;
Show all 10Show fewer
- Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography; no arrhythmia requiring treatment; Fridericia-corrected QT interval (QTcF) ≤ 470 ms; baseline oxygen saturation > 91% on room air;
- Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor sampling;
- Agree to use effective non-pharmacological contraceptive measures from the time of signing informed consent until 1 year after TIL cell infusion;
- Fully understand the trial and voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.
Who cannot join
- Patients with a history of severe hypersensitivity reactions to any drug used during the study;
- Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
- Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
- Active autoimmune disease requiring systemic treatment during the study;
- History of organ transplantation or hematopoietic stem cell transplantation;
- Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease that, in the investigator's judgment, requires immunosuppressive medication during the study. However, physiological doses of glucocorticoids, intranasal or topical corticosteroids are allowed;
Show all 17Show fewer
- Received systemic anticancer therapy within 4 weeks prior to preconditioning, or plan to participate in another interventional clinical trial during the study;
- Presence of acute or chronic infection, including: HIV positive, positive Treponema pallidum antibody, or clinically active hepatitis B or C; Active infection requiring systemic treatment or active tuberculosis infection;
- Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study;
- Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of lymphodepleting preconditioning, adoptive TIL therapy, and IL-2 adjuvant therapy;
- Diagnosis of another primary malignancy within 5 years prior to screening, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ;
- Severe respiratory disease;
- Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation;
- Known leptomeningeal metastasis; known other central nervous system metastases that are not effectively controlled after treatment or untreated;
- Previous treatment with a similar cell therapy product;
- Pregnant or breastfeeding women;
- Known psychiatric disorders, alcoholism, drug abuse, or substance abuse, and any other condition that the investigator considers unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shengxiang Ren Chief Physician, 021-65115006, harry_ren@126.com
About this study
Official title: A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer.
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
- Conditions
- Advanced NSCLC
- Being tested
- Cyclophosphamid, Fludarabine, Interleukin 2 subcutaneous injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamidDrug
Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.
FludarabineDrug
Fludarabine is administered once daily via intravenous infusion for 3 consecutive days.
Interleukin 2 subcutaneous injectionDrug
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 group | Role | What they receive |
|---|---|---|
| HS-IT101 monotherapy | Experimental | TIL Injection administered by intravenous infusion over 30-60 minutes Receives: Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Interleukin 2 subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Measured: 2 years
Evaluate the preliminary efficacy of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Measured: 2 years
Secondary outcomes (1)
Evaluate the pharmacokinetic (PK) characteristics of HS-IT101 injection.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start21 Sep 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Huasai Biomedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830342
- Sponsor's protocol ID
- HS-IT101-105
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT07830342
- Acronym / sponsor ID
- HS-IT101-105
- Conditions
- Advanced NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hangzhou Huasai Biomedicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-IT101 monotherapy | Experimental | Drug: Cyclophosphamid, Drug: Fludarabine, Drug: Interleukin 2 subcutaneous injectionTIL Injection administered by intravenous infusion over 30-60 minutes |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 75 years;
- Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;
- At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and/or biopsied for the preparation of autologous tumor-infiltrating lymphocytes;
- After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
- ECOG performance status ≤ 1;
Key exclusion criteria (17 listed)
- Patients with a history of severe hypersensitivity reactions to any drug used during the study;
- Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
- Any of the following events within 6 months prior to screening: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
- Active autoimmune disease requiring systemic treatment during the study;
- History of organ transplantation or hematopoietic stem cell transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamidCyclophosphamide administered via intravenous infusion once daily for 3 consecutive days. | Drug | HS-IT101 monotherapy |
| FludarabineFludarabine is administered once daily via intravenous infusion for 3 consecutive days. | Drug | HS-IT101 monotherapy |
| Interleukin 2 subcutaneous injectionIL-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. | Drug | HS-IT101 monotherapy |
Primary outcome
Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Time frame: 2 years
Evaluate the preliminary efficacy of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.
Time frame: 2 years
1 secondary outcome
Evaluate the pharmacokinetic (PK) characteristics of HS-IT101 injection.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced NSCLC
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 3
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
Non-small Cell Lung Cancer
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingPhase 1/2
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Non-small Cell Lung Cancer (NSCLC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamid, Fludarabine and Interleukin 2 subcutaneous injection in people with Advanced NSCLC, 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 10 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.