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HS-IT101 Injection in the Treatment of Advanced Melanoma

NCT06941818 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-14

No results posted yet for this study

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

Interventions

DRUG

HS-IT101 Injection

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

Sponsors & Collaborators

  • Qingdao Sino-Cell Biomedicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jun Guo, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-05-30
Completion
2027-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06941818 on ClinicalTrials.gov