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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT07245251
Brief Summary:
This is a single-arm, single-center, open-label, multiple-dose, dose-escalation early clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of STR-P004 in subjects with relapsed/refractory CD19-positive acute lymphoblastic leukemia.
Detailed Description:
The study adopts a dose-escalation approach combining "accelerated titration" and "traditional 3+3" design. Five dose-escalation cohorts are planned within the dose range of AA mg/kg to BB mg/kg. The escalation follows a modified Fibonacci sequence (i.e., 2, 1.67, 1.5, 1.4, 1.33, 1.33… multiples), with faster escalation in the early stages to minimize patient exposure to ineffective doses and quickly reach the predicted effective dose range, followed by reduced escalation rates to ensure safety and explore efficacy.
Study:
NCT07245251
Study Brief:
Protocol Section:
NCT07245251