ABC008 for Large Granular Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Abcuro, 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 day 1 and throughout the 48 weeks of follow up

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for adults with T-cell Large Granular Lymphocytic Leukemia.

Who is the study for?

Adults with T-cell Large Granular Lymphocytic Leukemia (T-LGLL) who have low neutrophil or hemoglobin levels, frequent infections, or symptoms of anemia can join. They must be over 18, have a BMI ≤35 kg/m2, and proper liver and kidney function. Excluded are those with more than three prior treatments for T-LGLL (except prednisone), other autoimmune diseases besides specified ones, active infections including TB, recent vaccinations or surgeries, organ transplants, HIV/HTLV positive status.

What is being tested?

The trial is testing ABC008 in adults with T-LGLL to see how they respond to different doses. It's an open-label study which means everyone knows what treatment they're getting; there's no placebo group.

What are the potential side effects?

Potential side effects of ABC008 aren't listed but may include reactions similar to other monoclonal antibodies such as allergic reactions or infusion-related issues since participants with known hypersensitivity to mAb therapies are excluded.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and throughout the 48 weeks of follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and throughout the 48 weeks of follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and throughout the 48 weeks of follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in ECG parameters

Change from baseline in safety lab (Coagulation)

Change from baseline in safety lab (Complement)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: ABC008 Dose Level 5 CohortExperimental Treatment1 Intervention

3.0 mg / kg ABC008 Subjects receive ABC008 every 4 weeks. Cohorts receive escalating doses of ABC008 until completion of cohort 5 or any cohort is determined to have exceeded the maximum tolerated dose.

Group II: ABC008 Dose Level 4 CohortExperimental Treatment1 Intervention

3.0 mg / kg ABC008 Subjects receive ABC008 every 8 weeks OR 1.5 mg / kg Subjects receive ABC008 every 4 weeks. Cohorts receive escalating doses of ABC008 until completion of cohort 5 or any cohort is determined to have exceeded the maximum tolerated dose.

Group III: ABC008 Dose Level 3 CohortExperimental Treatment1 Intervention

1.5 mg / kg ABC008 Subjects receive ABC008 every 8 weeks. Cohorts receive escalating doses of ABC008 until completion of cohort 5 or any cohort is determined to have exceeded the maximum tolerated dose.

Group IV: ABC008 Dose Level 2 CohortExperimental Treatment1 Intervention

0.75 mg / kg ABC008 Subjects receive ABC008 every 8 weeks. Cohorts receive escalating doses of ABC008 until completion of cohort 5 or any cohort is determined to have exceeded the maximum tolerated dose.

Group V: ABC008 Dose Level 1 CohortExperimental Treatment1 Intervention

0.25 mg / kg ABC008 Subjects receive ABC008 every 8 weeks. Cohorts receive escalating doses of ABC008 until completion of cohort 5 or any cohort is determined to have exceeded the maximum tolerated dose.

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