Trials / Recruiting
RecruitingNCT06431100
a Single-arm, Single-center, Open Clinical Study
Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (estimated)
- Sponsor
- Beijing Geekgene Technology Co., LTD · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.
Conditions
- Gastric Cancer
- Esophageal Cancer
- Cervical Cancer
- Non-Small Cell Lung Cancer NSCLC
- Triple Negative Breast Cancer TNBC
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TCR T-cells | The strengthened T cells are re-infused into the patient to achieve the killing effect |
Timeline
- Start date
- 2023-07-19
- Primary completion
- 2026-07-19
- Completion
- 2026-11-19
- First posted
- 2024-05-28
- Last updated
- 2024-05-28
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06431100. Inclusion in this directory is not an endorsement.