HS-IT101 Injection in the Treatment of Advanced Melanoma

NCT06941818 | Enrolling By Invitation Phase 1

• 1 other identifier: HS-IT101ST01-Ⅰ b
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (8)

• Adverse Events (AE)

  To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of adverse events

  12 months

• 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

  12 months

• 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

  Up to 36 months

• 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

  Up to 36 months

• 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

  Up to 36 months

• 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

  Up to 36 months

• Progression-Free-Survival (PFS)

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

  Up to 36 months

• Overall Survival (OS)

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

  Up to 36 months

Secondary Outcomes (1)

• Pharmacokinetic (PK) detection parameters for HS-IT101

  Up to 6 months

Study Arms (1)

HS-IT101 monotherapy

EXPERIMENTAL

TIL Injection administered by intravenous infusion over 30-60 minutes.

Drug: HS-IT101 Injection

Interventions

HS-IT101 Injection DRUG

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

HS-IT101 monotherapy

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Peking University Cancer Hospital

Beijing, China

Location

Study Officials

• Jun Guo, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 24, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)