NCT05342506

Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies

A Open, Single Arm, Phase IIa Clinical Study on the Safety, Pharmacokinetics, and Efficacy of ScTIL (Genetically Modified Tumor Infiltrating Lymphocytes) in the Treatment of Gynecological Malignancies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The primary endpoint was objective response rate, defined as the proportion of patients with complete or partial response. Secondary endpoints were duration of response (time from the first evidence of response to disease progression or death, whichever came first), progression-free survival (time from the treatment initiation to disease progression or death, whichever came first), overall survival (time from the treatment initiation to the date of death or end of follow-up).

Conditions

• Cervical Cancer
• Ovarian Cancer
• Malignant Trophoblastic Tumor

Interventions

Type	Name	Description
DRUG	Toripalimab + ScTIL	Toripalimab (80 mg iv) 24 hours before or concomitantly with ScTIL 3-5x10\^9 intravenous reinfusion.

Timeline

• Start date: 2022-04-18
• Primary completion: 2024-02-28
• Completion: 2024-05-31
• First posted: 2022-04-22
• Last updated: 2022-04-22