Trials / Recruiting
RecruitingNCT05430373
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
A Single-arm Phase I Clinical Study of GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Grit Biotechnology · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes： 1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine). 2. GT101 infusion. 3. post-infusion treatment (interleukin-2 intravenous push).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GT101 | Autologous tumor infiltrating lymphocyte injection |
Timeline
- Start date
- 2022-05-23
- Primary completion
- 2025-09-25
- Completion
- 2026-06-30
- First posted
- 2022-06-24
- Last updated
- 2026-04-14
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05430373. Inclusion in this directory is not an endorsement.