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BTK Inhibitor
TT-01488 for B-Cell Cancers
Phase 1
Recruiting
Led By Nitin Jain, MD
Research Sponsored by TransThera Sciences (Nanjing), Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 - 1.5 years
Awards & highlights
Study Summary
This trial is testing a new drug to treat B-cell malignancies in adults. The safety and preliminary efficacy of the drug will be evaluated in this phase I dose escalation study.
Eligible Conditions
- B Cell Cancers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 - 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 - 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose recommend for dose expansion (DRDE)
Dose-Limiting Toxicity (DLT) of TT-01488
Maximum Tolerated Dose (MTD), if reached, of TT-01488
Secondary outcome measures
Area under the concentration time curve (AUC 0-last)
Disease Control Rate (DCR)
Duration of Response (DOR)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion for TT-01488Experimental Treatment1 Intervention
TT-01488 tablets will be administered once daily in 28-day cycles to verify the safety and preliminary efficacy as observed in the dose escalation cohorts.
Group II: Dose Escalation for TT-01488Experimental Treatment1 Intervention
TT-01488 tablets will be administered once daily in a 28-day cycle in increasing strength in order to determine the recommended dose for dose expansion.
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Who is running the clinical trial?
TransThera Sciences (Nanjing), Inc.Lead Sponsor
14 Previous Clinical Trials
874 Total Patients Enrolled
Nitin Jain, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center (MDACC)
4 Previous Clinical Trials
1,650 Total Patients Enrolled
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