drugset / Trial / NCT05730361
Phase Ib Clinical Study on the Safety, the Tolerability, the Pharmacokinetics and the Efficacy of ScTIL Injection (Gene Modified Tumor Infiltrating Lymphocytes) Alone and in Combination With B Lymphocyte Adjuvant in the Treatment of Digestive System Malignant Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
This is an open-lable, single-arm, single-dose escalation and multiple-dose extention clinical study of cell therapy designed to observe and evaluate the tolerance, the pharmacokinetic characteristics, the safety and the efficacy of ScTIL210 injection alone and in combination with B lymphocytes adjuvant in the treatment of digestive system malignant solid tumors.
Timeline
- Start
- 2023-02
- Primary completion
- 2024-05
- Completion
- 2024-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | B lymphocytes adjuvant | Unknown | 5e+09 cells | — |
| Subject | B lymphocytes adjuvant | Unknown | 1.5e+10 cells | — |
| Subject | ScTIL | Cell therapy | 5e+09 cells | Intravenous |
| Subject | ScTIL | Cell therapy | 1.5e+10 cells | Intravenous |