ABC008 for Lymphoid leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Huntsman Cancer Institute, University of Utah, Salt Lake City, UT
Lymphoid leukemia+3 More
ABC008 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)

Eligible Conditions

  • Lymphoid leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 28 Secondary · Reporting Duration: Day 1 and throughout the 48 weeks of follow up

Week 48
Duration of response at all time points assessed
Overall survival at Week 48
Percentage of subjects demonstrating complete response at all time points assessed
Percentage of subjects demonstrating overall response (defined as total number of subjects with CR or PR) at all time points assessed
Percentage of subjects demonstrating partial response at all time points assessed
The apparent clearance [CL/F] of ABC008
The apparent volume of distribution [Vd/F] of ABC008
The area under the concentration-time curve [AUC] of ABC008
The change from baseline in levels of KLRG1 expressing lymphocytes over time
The change from baseline in levels of T-LGL counts over time
The change from baseline in levels of lymphocyte subsets over time
The elimination half-life [t½] of ABC008
The maximum serum concentration [CMax] of ABC008
The time to maximum concentration [TMax] of ABC008
Week 48
Change from baseline in ECG (Heart Rate)
Change from baseline in ECG (Rhythm)
Change from baseline in ECG parameters
Change from baseline in safety lab (CMV Viral Load)
Change from baseline in safety lab (Chemistry)
Change from baseline in safety lab (Coagulation)
Change from baseline in safety lab (Complement)
Change from baseline in safety lab (Cytokines)
Change from baseline in safety lab (EBV Viral Load)
Change from baseline in safety lab (Hematology)
Change from baseline in vital sign (Systolic and diastolic blood pressure)
Change from baseline in vital sign (pulse rate)
Change from baseline in vital sign (respiratory rate)
Change from baseline in vital sign (temperature)
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

ABC008 Dose Level 2 Cohort
1 of 4
ABC008 Dose Level 1 Cohort
1 of 4
ABC008 Dose Level 3 Cohort
1 of 4
ABC008 Dose Level 4 Cohort
1 of 4
Experimental Treatment

15 Total Participants · 4 Treatment Groups

Primary Treatment: ABC008 · No Placebo Group · Phase 1 & 2

ABC008 Dose Level 2 Cohort
Drug
Experimental Group · 1 Intervention: ABC008 · Intervention Types: Drug
ABC008 Dose Level 1 Cohort
Drug
Experimental Group · 1 Intervention: ABC008 · Intervention Types: Drug
ABC008 Dose Level 3 Cohort
Drug
Experimental Group · 1 Intervention: ABC008 · Intervention Types: Drug
ABC008 Dose Level 4 Cohort
Drug
Experimental Group · 1 Intervention: ABC008 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 and throughout the 48 weeks of follow up
Closest Location: Huntsman Cancer Institute, University of Utah · Salt Lake City, UT
Photo of Salt Lake City 1Photo of Salt Lake City 2Photo of Salt Lake City 3
2013First Recorded Clinical Trial
0 TrialsResearching Lymphoid leukemia
9 CompletedClinical Trials

Who is running the clinical trial?

Abcuro, Inc.Lead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age.
You have a body mass index (BMI) of less than 35 kg/m2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.