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Melanoma (Excluding Uveal Melanoma)Phase 2NCT07406724

HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）

A Phase 2 study testing Tumor Tissue Sampling, Lymphodepletion Conditioning and Infusion of HS-IT101 Injection in people with Melanoma (Excluding Uveal Melanoma), 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
Search all trials

Trial summary

This is a multicenter, randomized controlled, open-label Phase II clinical study designed to evaluate the efficacy and safety of HS-IT101 Injection versus the investigator's choice of chemotherapy in participants with advanced melanoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma (Excluding Uveal Melanoma)
What is being tested?
Tumor Tissue Sampling, Lymphodepletion Conditioning and Infusion of HS-IT101 Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
26 Feb 2026to 31 Dec 2028
Phase
Phase 2
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

  • Participants aged 18 to 75 years, inclusive.
  • Patients with cytologically or histologically confirmed unresectable advanced, recurrent, or metastatic melanoma (excluding uveal melanoma), who have experienced disease progression after failure of systemic therapy recommended in the 2025 CSCO Guidelines.
  • Disease Progression Following Anti-PD-1 Therapy.
  • At least one tumor lesion not treated with radiotherapy or other local therapies within 28 days prior to resection, suitable for autologous tumor-infiltrating lymphocyte (TIL) preparation, with a minimum tissue weight of ≥0.050 g.
  • At least one measurable tumor lesion per RECIST 1.1 after tumor tissue sampling.
  • ECOG performance status ≤ 1.
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  • Expected survival ≥ 3 months.
  • Adequate organ and bone marrow function as confirmed by screening assessments.
  • Documented by echocardiography showing left ventricular ejection fraction (LVEF) ≥50%；Absence of arrhythmia requiring therapeutic intervention；Electrocardiogram (ECG) criteria；QT interval corrected by Frederica's formula (QTcF) ≤470 ms；Baseline peripheral oxygen saturation (SpO₂) >91% in room air.
  • Adverse reactions from prior therapy have resolved to CTCAE v5.0 grade ≤1 before randomization, except for hypothyroidism and alopecia judged by the investigator as non-safety concerns.
  • Effective non-pharmacological contraceptive measures must be used from the signing of the informed consent form until 1 year after TIL cell infusion.
  • The subject fully understands the trial, voluntarily provides written informed consent, and is able to comply with scheduled visits and protocol-specified procedures.

Who cannot join

  • Patients with a history of severe hypersensitivity reactions (e.g., anaphylaxis, Stevens-Johnson syndrome, or toxic epidermal necrolysis) to any component of the following agents.
  • Presence of any uncontrolled clinical conditions, including but not limited to:
  • Poorly controlled hypertension (systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg at rest despite antihypertensive therapy);
  • Congestive heart failure (NYHA Class III/IV).
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE); 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 within the past 6 months.
  • Active autoimmune diseases requiring systemic therapy during the study period（Subjects with the following conditions may be enrolled：Eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy within the last 2 years and not expected to recur, or other autoimmune diseases under stable control;Hypothyroidism requiring only thyroid hormone replacement;Type 1 diabetes requiring only insulin replacement therapy.）
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  • Organ transplant or history of hematopoietic stem cell transplantation.
  • Use of systemic immunosuppressive agents (e.g., corticosteroids) within 4 weeks prior to randomization, or presence of comorbid conditions requiring such medications during the trial period.Exception: Intranasal or topical corticosteroids are permitted.
  • Receipt of systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization, or planned participation in another interventional clinical trial during the study period.
  • Acute or chronic infections, including:
  • HIV-positive status, Treponema pallidum antibody positivity, or clinically active hepatitis B or C(Note: For hepatitis B, HBsAg- or HBeAg-positive individuals with HBV DNA below the lower limit of normal at the study site may be enrolled; for hepatitis C, HCVAb-positive individuals with HCV RNA below the lower limit of normal at the study site may be enrolled);
  • Active infections requiring systemic therapy or active tuberculosis infection.
  • Subjects who received any live attenuated vaccine within 3 months prior to screening or planning to receive live vaccines during the trial period.
  • Subjects who have undergone major organ surgery or experienced clinically significant trauma within 4 weeks prior to screening, or require elective surgery during the trial period.
  • Patients presenting with pre-screening surgical complications or delayed wound healing, and deemed by the investigator to confer increased risks during lymphodepleting pretreatment, adoptive TIL therapy, and high-dose IL-2 adjuvant therapy.
  • Patients with a history of other primary malignancies diagnosed within 5 years prior to screening are excluded, except for radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ.
  • Patients with severe respiratory diseases (including but not limited to a documented history of or concurrent severe interstitial lung disease (ILD), severe chronic obstructive pulmonary disease (COPD), profound pulmonary insufficiency, or symptomatic bronchospasm).
  • Patients requiring surgical intervention for gastrointestinal hemorrhage, localized intestinal ischemia, or intestinal perforation.
  • Patients with symptomatic central nervous system (CNS) metastases
  • Patients with clinical symptoms of central nervous system (CNS) metastases who have received prior therapy for brain metastases and maintained radiographic stability (confirmed by MRI) for at least 12 weeks may be enrolled.
  • Pregnant or lactating women.
  • Individuals with a known history of psychiatric disorders, alcoholism, drug abuse, or substance abuse, as well as any other conditions deemed unsuitable for participation by the investigator .

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

  • Beijing Cancer Hospital

    Beijing

    Jun.Guo, 010-88121122, guoj307@126.com

    Recruiting

Other trials in China

About this study

Official title: Randomized, Controlled, Open-label Phase 2 Clinical Trial of HS-IT101 Injection Versus Chemotherapy for Patients With Advanced Melanoma

This is a multicenter, randomized controlled, open-label Phase II clinical study designed to evaluate the efficacy and safety of HS-IT101 Injection versus the investigator's choice of chemotherapy in participants with advanced melanoma. A total of 90 participants are planned to be enrolled, and eligible participants will be randomly assigned to the experimental group or control group at a 1:1 ratio. The experimental group will receive a single administration of autologous tumor-infiltrating lymphocyte therapy, while the control group will receive chemotherapy regimens selected by the research physicians. Efficacy and safety evaluations will be conducted for all enrolled participants throughout the study.

Being tested
Tumor Tissue Sampling, Lymphodepletion Conditioning, Infusion of HS-IT101 Injection, IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy, Investigator's selection of appropriate chemotherapy regimen
Keywords
Advanced Melanoma
Medical subject headings
Melanoma

What participants receive

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

  • Tumor Tissue SamplingProcedure or surgery

    Surgical procurement of the subject's tumor tissue for autologous tumor-infiltrating lymphocyte (TIL) preparation

  • Lymphodepletion ConditioningDrug

    Intravenous Infusion of Cyclophosphamide and Fludarabine

  • Infusion of HS-IT101 InjectionDrug

    Single intravenous infusion of HS-IT101 Injection following lymphodepletion conditioning

  • IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) TherapyDrug

    Subcutaneous injection of IL-2 following intravenous infusion of HS-IT101 Injection

  • Investigator's selection of appropriate chemotherapy regimenDrug

    Single-agent or combination chemotherapy regimens include dacarbazine, temozolomide, paclitaxel, and carboplatin.

Study groups in NCT07406724
Study groupRoleWhat they receive
HS-IT101 monotherapyExperimentalTumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
Receives: Procedure: Tumor Tissue Sampling; Drug: Lymphodepletion Conditioning; Drug: Infusion of HS-IT101 Injection; Drug: IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
Investigator's Choice of Chemotherapy RegimensActive comparatorNot described
Receives: Drug: Investigator's selection of appropriate chemotherapy regimen

What is being measured

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

  1. PFS

    Progression-Free Survival (PFS) assessed by Independent Review Committee (IRC)

    Measured: 1 year

Secondary outcomes (6)

  1. OS

    Time from randomization to death from any cause, as well as 6-month and 12-month Overall Survival (OS) rates

    Measured: 1 year

  2. ORR

    Proportion of subjects with best overall response (BOR) of either partial response (PR) or complete response (CR)

    Measured: 1 year

  3. DCR

    Proportion of subjects with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among total evaluable cases

    Measured: 1 year

  4. DOR

    The time from first documentation of complete response (CR) or partial response (PR) to first documented progressive disease (PD) or all-cause death, whichever occurs first

    Measured: 1 year

  5. TTR

    Time to First Response (TTR) from randomization in participants with a best overall response (BOR) of Complete Response (CR) or Partial Response (PR)

    Measured: 1 year

  6. PFS

    Progression-Free Survival (PFS) assessed by Investigator

    Measured: 1 year

Timeline

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

  1. First posted12 Feb 2026
  2. Study start26 Feb 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07406724
Sponsor's protocol ID
HS-IT101ST01-Ⅱ
Status last verified
Feb 2026
First submitted
2 Feb 2026
Last updated
27 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 2 study testing Tumor Tissue Sampling, Lymphodepletion Conditioning and Infusion of HS-IT101 Injection in people with Melanoma (Excluding Uveal Melanoma), 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 12 inclusion and 22 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

PFS (time frame: 1 year). 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 NCT07406724.

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 27 Oct 2026.

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