Trials / Recruiting
RecruitingNCT05142475
A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Breast Cancer
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Shanghai Juncell Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tumor Infiltrating Lymphocytes (TIL) | Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes. |
Timeline
- Start date
- 2021-11-19
- Primary completion
- 2026-12-20
- Completion
- 2027-12-20
- First posted
- 2021-12-02
- Last updated
- 2025-12-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05142475. Inclusion in this directory is not an endorsement.