A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
NCT05142475 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-12-11
Summary
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Conditions
- Breast Cancer
- Treatment Side Effects
- Advanced Breast Cancer
- Effects of Immunotherapy
Interventions
- BIOLOGICAL
-
Tumor Infiltrating Lymphocytes (TIL)
Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.
Sponsors & Collaborators
-
Shanghai 10th People's Hospital
collaborator OTHER -
Shanghai Juncell Therapeutics
lead INDUSTRY
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
- 2021-11-19
- Primary Completion
- 2026-12-20
- Completion
- 2027-12-20
Countries
- China
Study Locations
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