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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05070156
Brief Summary:
This is an Open-label, Single Arm study to observe the safety and tolerability of B010-A in the treatment of advanced hepatocellular carcinoma.
Detailed Description:
All subjects participating in this study will receive peripheral blood mononuclear cell collection to produce B010-A injection products after enrollment. Subjects may receive bridging anti-cancer therapy while waiting for the production of B010-A injection. All subjects need to undergo baseline assessment before receiving cell infusion. For all subjects, the baseline assessment includes weight, body surface area, vital signs, physical examination, ECOG score, laboratory examination, coagulation function, etiological examination, 12-lead ECG, echocardiogram, cytokine testing, Tumor marker detection and ICE score, etc. Each subject will receive lymphodepletion prior to B010-A infusion, and dose-limiting toxicity (DLT) assessment will be performed on D28 after the first infusion.
Study:
NCT05070156
Study Brief:
Protocol Section:
NCT05070156