Clinical Trials Logo

Clinical Trial Summary

This is a 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 NCT05683717
Study type Interventional
Source TransThera Sciences (Nanjing), Inc.
Contact Sun Caixia, PhD
Phone 025-58216298
Email clinicaltrial@transtherabio.com
Status Recruiting
Phase Phase 1
Start date March 30, 2023
Completion date October 30, 2028

See also
  Status Clinical Trial Phase
Completed NCT02343120 - Study of the Safety and Pharmacokinetics of BGB-3111 in Subjects With B-Cell Lymphoid Malignancies Phase 1/Phase 2
Completed NCT02018861 - A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101) Phase 1/Phase 2
Terminated NCT03701438 - Immune Response to Influenza Vaccine in Adults With B-cell Malignancies Treated With Idelalisib
Completed NCT02327078 - A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204) Phase 1/Phase 2
Completed NCT04551963 - Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Participants With B-Cell Malignancies Phase 1
Completed NCT01775631 - Combination Study of Urelumab and Rituximab in Patients With B-cell Non-Hodgkins Lymphoma Phase 1
Active, not recruiting NCT01905813 - Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies Phase 1
Recruiting NCT05275504 - Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies Phase 1
Active, not recruiting NCT02457598 - Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies Phase 1
Recruiting NCT03050190 - A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies Phase 1/Phase 2
Recruiting NCT03125577 - Combination CAR-T Cell Therapy Targeting Hematological Malignancies Phase 1/Phase 2
Recruiting NCT04170283 - Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies Phase 3
Recruiting NCT04509700 - Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) Phase 2
Not yet recruiting NCT03642496 - Clinical Study of ET019002-T Cell Therapy for Refractory/Relapsed B-Cell Malignancies Early Phase 1
Completed NCT00983619 - A Clinical Study Using MEDI-551 in Adult Participants With Relapsed or Refractory Advanced B-Cell Malignancies Phase 1/Phase 2