HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma

NCT07406724 | Not Yet Recruiting Phase 2

• 1 other identifier: HS-IT101ST01-Ⅱ
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Melanoma (Excluding Uveal Melanoma)

Keywords

Advanced Melanoma

Outcome Measures

Primary Outcomes (1)

• PFS

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

  1 year

Secondary Outcomes (6)

• OS

  1 year

• ORR

  1 year

• DCR

  1 year

• DOR

  1 year

• TTR

  1 year

Study Arms (2)

HS-IT101 monotherapy

EXPERIMENTAL

Tumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy

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 Regimens

ACTIVE COMPARATOR

Drug: Investigator's selection of appropriate chemotherapy regimen

Interventions

Tumor Tissue Sampling PROCEDURE

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

HS-IT101 monotherapy

Lymphodepletion Conditioning DRUG

Intravenous Infusion of Cyclophosphamide and Fludarabine

HS-IT101 monotherapy

Infusion of HS-IT101 Injection DRUG

Single intravenous infusion of HS-IT101 Injection following lymphodepletion conditioning

HS-IT101 monotherapy

IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy DRUG

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

HS-IT101 monotherapy

Investigator's selection of appropriate chemotherapy regimen DRUG

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

Investigator's Choice of Chemotherapy Regimens

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.）
• 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.

Sponsors & Collaborators

• Qingdao Sino-Cell Biomedicine Co., Ltd.: lead

MeSH Terms

Conditions

Melanoma

Interventions

Toll-Like Receptor 1; Therapeutics

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Toll-Like Receptors; Receptors, Pattern Recognition; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 12, 2026
• Study Start: February 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share