drugset / Trial / NCT05342506
Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies
Phase 2
Unknown
30 enrolled
Peking Union Medical College Hospital
Chineo Medicine (Beijing) Co., Ltd. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and clinical efficacy of ScTIL in the treatment of recurrent or refractory cervical cancer, ovarian cancer and malignant trophoblastic tumor, to evaluate the pharmacokinetic characteristics of ScTIL, and to explore and analyze the changes of CTC, ctDNA and immunohistochemical Library of malignant tumor subjects before and after ScTIL treatment.Treatment will be terminated upon progressive disease, unacceptable toxicity, or withdrawal of consent. Subjects with responses other than progressive disease will receive subsequent rounds of ScTIL treatment.
Timeline
- Start
- 2022-04-18
- Primary completion
- 2024-02-28
- Completion
- 2024-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ScTIL | Cell therapy | — | Intravenous |
| Background | Toripalimab | Monoclonal antibody | 80 mg | Intravenous |