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HS-IT101 Injection in the Treatment of Advanced Melanoma | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATIONPHASE1

HS-IT101 Injection in the Treatment of Advanced Melanoma

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

NCT06941818•Qingdao Sino-Cell Biomedicine Co., Ltd.

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.

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 75 years (inclusive).
•2. 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.
•3. 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.
•4. 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.
•5. ECOG performance status ≤1.
•6. Life expectancy ≥3 months.
•7. 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:
+20 more criteria

Exclusion Criteria

•1. 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).
•2. 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).
•3. 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.
•4. 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).
•5. History of organ transplantation or hematopoietic stem cell transplantation.
•6. 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);
+3 more criteria

Locations (1)

Peking University Cancer Hospital

Beijing, China

Key Dates

Start Date

July 10, 2025

Primary Completion Date

May 30, 2026

Completion Date

May 30, 2027

Last Updated

August 14, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Melanoma

Interventions

HS-IT101 Injection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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HS-IT101 Injection in the Treatment of Advanced Melanoma

Inclusion Criteria

Exclusion Criteria

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