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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 - 1.5 years for reporting.

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 more

Trial 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

13 Previous Clinical Trials

896 Total Patients Enrolled

Nitin Jain, MDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center (MDACC)

4 Previous Clinical Trials

1,650 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims are the researchers seeking to achieve with this experimental program?

"This clinical trial will monitor a range of efficacy, safety and pharmacokinetic measures in order to assess the Dose-Limiting Toxicity (DLT) of TT-01488. Specifically, secondary outcomes include Objective Response Rate (ORR), Mean Residence Time (MRT), as well as any adverse events that might be linked with treatment. In addition, CTCAE v5.0 parameters such as laboratory tests and vital signs will also be monitored over 28 days after first dose ."

Answered by AI

Is enrollment in this trial still an option for potential participants?

"According to information published on clinicaltrials.gov, the recruitment phase of this trial is now open. The study was posted online on June 1st 2022, with its most recent update occurring just a week later."

Answered by AI

Has the FDA authorized TT-01488 for commercial use?

"There is limited evidence of TT-01488's safety and efficacy, thus it was given a score of 1."

Answered by AI

How many participants can the researchers include in this experiment?

"Affirmative, the clinicaltrials.gov website indicates that this medical trial is currently looking for participants to enrol. The initial posting on June 1st 2022 was followed by a final edit on June 8th of the same year. This study needs 37 volunteers from two sites in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies

2022. "Study to Evaluate the Safety and Tolerability of TT-01488 in Patients With B-Cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05275504.