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Monoclonal Antibodies

ABC008 for Large Granular Lymphocytic Leukemia

Phase 1 & 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0

Secondary outcome measures

Electrocardiogram

Change from baseline in ECG (Rhythm)

Change from baseline in ECG parameters

+25 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abcuro, Inc.Lead Sponsor

2 Previous Clinical Trials

261 Total Patients Enrolled

Media Library

Large Granular Lymphocytic Leukemia Clinical Trial 2023: ABC008 Highlights & Side Effects. Trial Name: NCT05532722 — Phase 1 & 2

Frequently Asked Questions

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

Is there a limit to the number of participants in this medical experiment?

"Affirmative. The information on clinicaltrials.gov indicates that this trial has been actively searching for participants since September 28th 2022 and was recently amended the 16th of November, with a quota of 15 patients from one medical centre."

Answered by AI

Are enrolments still open for this trial?

"Affirmative. The information hosted by clinicaltrials.gov confirms that this research is actively searching for participants, with the first posting being made on September 28th 2022 and last updated November 16th 2022. Fifteen patients are required from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)

2022. "ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05532722.