Trials / Recruiting
RecruitingNCT06716619
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
A Phase I Clinical Trial of the Safety and Tolerability of Tumor-Associated Lymph Node T-Cell Injection (TAL-T) in Subjects With Advanced Malignant Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer.
Detailed description
The study was divided into two phases, the dose-range exploration study and the expanded enrollment study. Exploration of the dosage range phase and the expanded enrollment phase were designed to evaluate the safety, tolerability, and initial efficacy of TAL-T cell therapy in patients with advanced solid tumors
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tumor Associated Lymph node T cell | At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells . After lymphodepletion, patients are infused with TAL-T. |
| DRUG | Serplulimab Injection | Srulizumab injection was given intravenous infusion both before and after the TAL-T cells infusion. |
Timeline
- Start date
- 2025-02-13
- Primary completion
- 2026-12-19
- Completion
- 2027-12-19
- First posted
- 2024-12-04
- Last updated
- 2025-03-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06716619. Inclusion in this directory is not an endorsement.