Health TrialsbyHealthPanel

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

ConditionMelanoma (Excluding Uveal Melanoma)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorQingdao Sino-Cell Biomedicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tumor Tissue Sampling

    Procedure/Surgery

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

  • Lymphodepletion Conditioning

    Drug

    Intravenous Infusion of Cyclophosphamide and Fludarabine

  • Infusion of HS-IT101 Injection

    Drug

    Single intravenous infusion of HS-IT101 Injection following lymphodepletion conditioning

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

    Drug

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

  • Investigator's selection of appropriate chemotherapy regimen

    Drug

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

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: HS-IT101 monotherapyExperimental treatment 4 interventions
Group B: Investigator's Choice of Chemotherapy RegimensActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

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

Time frame
1 year

Secondary outcomes

1

OS

Time from randomization to death from any cause, as well as 6-month and 12-month Overall Survival (OS) rates

Time frame
1 year
2

ORR

Proportion of subjects with best overall response (BOR) of either partial response (PR) or complete response (CR)

Time frame
1 year
3

DCR

Proportion of subjects with best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) among total evaluable cases

Time frame
1 year
4

DOR

The time from first documentation of complete response (CR) or partial response (PR) to first documented progressive disease (PD) or all-cause death, whichever occurs first

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingdao Sino-Cell Biomedicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: