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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT05775666
Brief Summary:
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Detailed Description:
This study will include two parts, dose escalation phase (accelerated titration and 3+3 design) followed by a dose expansion phase (Cohort 1: Malignant mesothelioma; Cohort 2: Advanced malignant tumors of the digestive system; Cohort 3: Other advanced malignant solid tumors.).
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection.
The dose escalation phase will determine the maximum tolerated dose (MTD) of UCLM802 cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of UCLM802 cell injection, and establish recommended phase 2 dose (RP2D).
Study:
NCT05775666
Study Brief:
Protocol Section:
NCT05775666