Randomized, Controlled, Open-label Phase 2 Clinical Trial of HS-IT101 Injection Versus Chemotherapy for Patients With Advanced Melanoma
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- PFS
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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.
排除标准
- •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:
研究组 & 干预措施
HS-IT101 monotherapy
Tumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
干预措施: Tumor Tissue Sampling (Procedure)
HS-IT101 monotherapy
Tumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
干预措施: Lymphodepletion Conditioning (Drug)
HS-IT101 monotherapy
Tumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
干预措施: Infusion of HS-IT101 Injection (Drug)
HS-IT101 monotherapy
Tumor Tissue Sampling、Bridging Therapy、Lymphodepletion Conditioning、Infusion of HS-IT101 Injection、IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy
干预措施: IL-2 Administration for Tumor-Infiltrating Lymphocyte (TIL) Therapy (Drug)
Investigator's Choice of Chemotherapy Regimens
干预措施: Investigator's selection of appropriate chemotherapy regimen (Drug)
结局指标
主要结局
PFS
时间窗: 1 year
Progression-Free Survival (PFS) assessed by Independent Review Committee (IRC)
次要结局
- OS(1 year)
- ORR(1 year)
- DCR(1 year)
- DOR(1 year)
- TTR(1 year)
- PFS(1 year)