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Clinical Trial Summary

This is a first-in-human (FIH), multicenter, open-label Phase I dose escalation study to evaluate the safety and preliminary efficacy of the TT-01488 tablet, a non-covalent reversible BTK inhibitor, for the treatment of adult patients with B-cell malignancies.


Clinical Trial Description

The study will consist of two parts, dose escalation and dose expansion. A modified 3+3 design will be used to guide the dose escalation and the determination of the dose recommended for dose expansion (DRDE). A sentinel cohort comprising of one subject will be enrolled at a starting dose of 50 mg q.d. Subsequently, patients will be enrolled according to the standard 3+3 dose escalation design to determine the DRDE. Once the DRDE has been selected, TT-01488 of DRDE will be further tested in the dose expansion cohort to verify the safety and preliminary efficacy as observed in the dose escalation cohorts. A recommended Phase II dose (RP2D) may be determined based on the totality of safety, pharmacokinetics, and efficacy data from the dose escalation cohorts and dose expansion cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05275504
Study type Interventional
Source TransThera Sciences (Nanjing), Inc.
Contact Caixia Sun, PhD
Phone 025-58216298
Email clinicaltrial@transtherabio.com
Status Recruiting
Phase Phase 1
Start date June 2022
Completion date April 2023

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