Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT06658951
Brief Summary:
This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.
Detailed Description:
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine, cyclophosphamide and ABRAXANE followed by Anti-HER2 CAR-T cell injection.The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-HER2 CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-HER2 CAR-T cell injection, and establish recommended phase 2 dose (RP2D).
Study:
NCT06658951
Study Brief:
Protocol Section:
NCT06658951