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Advanced MelanomaPhase 1NCT06941818

HS-IT101 Injection in the Treatment of Advanced Melanoma(FASTIL-Mela01)

A Phase 1 study testing HS-IT101 Injection in people with Advanced Melanoma, run by Hangzhou Huasai Biomedicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced melanoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Melanoma
What is being tested?
HS-IT101 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
10 Jul 2025to 1 Oct 2026
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

  • Age between 18 and 75 years (inclusive).
  • Histologically or cytologically confirmed advanced, recurrent, or metastatic melanoma (excluding uveal melanoma) that has failed at least one prior line of standard systemic therapy. Subjects with BRAF V600 mutations must have failed BRAF-targeted therapy or been intolerant to such therapy due to toxicity. The necessity and appropriateness of targeted therapy shall be determined by the investigator based on the subject's clinical status.
  • At least one tumor lesion (not subjected to radiotherapy or local therapy within 28 days prior to sampling) must be available for autologous tumor-infiltrating lymphocyte (TIL) preparation, with a minimum tissue weight of ≥0.050 g.
  • At least one measurable lesion (per RECIST 1.1 criteria) must remain after sampling. This lesion must not have received prior radiotherapy or local therapy unless performed >28 days before tumor sampling and demonstrating clear progression.
  • ECOG performance status ≤1.
  • Life expectancy ≥3 months.
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  • Adequate organ and bone marrow function at screening, defined as:
  • Hematology:
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet count (PLT) ≥90×10⁹/L; Hemoglobin (HGB) ≥90 g/L (no transfusion or erythropoietin within 14 days).
  • Liver function:
  • ALT/AST ≤2.5×ULN (≤5×ULN for liver metastases); Total bilirubin (TBil) ≤1.5×ULN (≤3×ULN if Gilbert's syndrome is confirmed).
  • Renal function:
  • Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥60 mL/min (Cockcroft-Gault formula).
  • Coagulation:
  • Activated partial thromboplastin time (APTT) ≤1.5×ULN; International normalized ratio (INR) and prothrombin time (PT) ≤1.5×ULN.
  • Cardiac function criteria:
  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; No clinically significant arrhythmias requiring treatment; QTcF interval ≤470 ms (calculated using Fridericia's formula: QTcF = QT/(RR⁰.³³), where RR = 60/heart rate. If initial result is abnormal, repeat twice at 5-minute intervals; use mean value for eligibility); Baseline oxygen saturation >91% in room air.
  • Prior treatment-related toxicities resolved to CTCAE v5.0 Grade ≤1 (excluding alopecia or other toxicities deemed non-risk by the investigator) before tumor sampling.
  • Agreement to use effective non-pharmacologic contraception from informed consent signing until 1 year post-TIL infusion.
  • Willing and able to comply with study visits/procedures, with full understanding of the trial and provision of written informed consent.

Who cannot join

  • History of severe allergic reactions to medications used in the study (including but not limited to cyclophosphamide, fludarabine, IL-2, gentamicin, amphotericin B, or components of TIL infusion).
  • Uncontrolled clinical conditions, including:
  • Poorly controlled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medication);
  • Congestive heart failure (NYHA Class III/IV).
  • Within 6 months prior to screening:
  • Deep vein thrombosis, pulmonary embolism, myocardial infarction, severe/unstable arrhythmia, angina pectoris, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, cerebrovascular accident, transient ischemic attack, or cerebral embolism.
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  • Active autoimmune diseases requiring systemic therapy during the study period (except: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in the past 2 years; hypothyroidism managed with thyroid hormone replacement; type 1 diabetes managed with insulin; or autoimmune conditions deemed non-recurrent by the investigator).
  • History of organ transplantation or hematopoietic stem cell transplantation.
  • Use of immunosuppressive drugs (e.g., corticosteroids) within 4 weeks prior to tumor sampling, or concurrent conditions requiring immunosuppressive therapy during the study. Exceptions:
  • Physiological-dose glucocorticoids (≤12 mg/m²/day hydrocortisone or equivalent);
  • Topical or intranasal steroids.
  • Systemic anticancer therapy within 4 weeks prior to preconditioning (including investigational drugs; applies to agents with a half-life <4 weeks [whichever is shorter]) or plans to participate in other interventional trials during the study.
  • Acute/chronic infections, including:
  • HIV positivity, syphilis antibody positivity, or active hepatitis B/C (subjects with HBsAg/HBeAg positivity are eligible if HBV DNA is below the lower limit of detection [LLOD]; HCVAb-positive subjects are eligible if HCV RNA is below LLOD);
  • Active infections requiring systemic therapy or active tuberculosis.
  • Major organ surgery, significant trauma within 4 weeks prior to screening, or planned elective surgery during the trial.
  • Surgical complications or delayed wound healing (investigator-assessed to increase risks of preconditioning, TIL therapy, or IL-2 administration).
  • Other primary malignancies diagnosed within 5 years prior to screening (exceptions: radically treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ).
  • Severe respiratory diseases (e.g., interstitial lung disease, severe COPD, pulmonary insufficiency, symptomatic bronchospasm).
  • Gastrointestinal bleeding requiring surgery, intestinal ischemia, or perforation.
  • Leptomeningeal metastasis or uncontrolled/untreated CNS metastases (excludes asymptomatic CNS metastases stable for ≥4 weeks post-treatment without corticosteroids/anticonvulsants).
  • Prior treatment with cell therapy products of the same class.
  • Pregnancy, lactation, or refusal to use contraception.
  • Psychiatric disorders, substance abuse, or other investigator-determined contraindications.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Melanoma

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced melanoma.

Read the detailed description

HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with advanced melanoma. The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide, followed by infusion of autologous TIL, then finnaly followed by the administration of a regimen of IL-2.

Being tested
HS-IT101 Injection

What participants receive

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

  • HS-IT101 InjectionDrug

    Adoptive transfer of 5x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes.

Study groups in NCT06941818
Study groupRoleWhat they receive
HS-IT101 monotherapyExperimentalTIL Injection administered by intravenous infusion over 30-60 minutes.
Receives: Drug: HS-IT101 Injection

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

  7. Progression-Free-Survival (PFS)

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

    Measured: Up to 36 months

  8. Overall Survival (OS)

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

    Measured: Up to 36 months

Secondary outcomes (1)

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

    Pharmacokinetic (PK) detection parameters for HS-IT101 injection include peripheral blood lymphocyte subsets and 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 posted24 Apr 2025
  2. Study start10 Jul 2025
  3. Primary completion20 Feb 2026
  4. Study completion1 Oct 2026

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
NCT06941818
Sponsor's protocol ID
HS-IT101ST01-Ⅰ b
Status last verified
Jul 2025
First submitted
15 Apr 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 HS-IT101 Injection in people with Advanced 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 20 inclusion and 24 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: finished, 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse Events (AE) (time frame: 12 months). The study lists 8 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 NCT06941818.

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.

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