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An Open- Label, Single-arm, Dose-escalation Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ST002 in the Treatment of Patients with NF2 Mutation-related Solid Tumors
This is an open-label, single-arm, dose-escalation pilot study to evaluate the safety, tolerability and preliminary efficacy of ST002 in the treatment of patients with NF2 mutation-related solid tumors. ST002 injection is a gene therapy product designed for NF2. By reinserting the normal XXX gene into genetically deficient tumor cells, the product expresses Merlin. This regulates gene transcription in tumor cells, controls the tumor microenvironment, and inhibits tumor growth and invasion, achieving therapeutic effects.
This is an open-label, single-arm, dose-escalation pilot study to evaluate the safety, tolerability and preliminary efficacy of ST002 in the treatment of patients with NF2 mutation-related solid tumors. Using a 3+3 dose escalation design, three dose groups are formulated, and three to six patients are expected to be enrolled in each dose group. A total of nine to eighteen - patients with NF2 gene mutation related solid tumors will be enrolled.
Age
16 - No limit years
Sex
ALL
Healthy Volunteers
No
Shuhang Wang
Beijing, Beijing Municipality, China
Start Date
February 15, 2025
Primary Completion Date
February 1, 2026
Completion Date
February 1, 2027
Last Updated
February 19, 2025
9
ESTIMATED participants
ST002
GENETIC
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Data Source & Attribution
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