ABC008 for Large Granular Lymphocytic Leukemia

Recruiting at 7 trial locations

Overseen By Michael McClain

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Abcuro, Inc.

Disqualifiers: Reactive lymphocytosis, Active anemia, Autoimmune diseases, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Eligibility Criteria

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.

Inclusion Criteria

I have low white blood cells or anemia, or I've needed a blood transfusion recently.

Agrees to adhere to the current Centers for Disease Control advice regarding minimizing exposure to severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) from the first Screening Visit until the End of Study (EOS)/Early Termination Visit (ETV)

My liver and kidney functions are normal.

Exclusion Criteria

I have an autoimmune disease other than RA, IBM, SS, or thyroid issues.

Has reactive large granular lymphocytosis

I have had a severe shingles infection that needed hospital care or IV drugs in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of ABC008 every 4 to 8 weeks until completion of cohort 5 or determination of maximum tolerated dose

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Treatment Details

Interventions

• ABC008

Trial Overview 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.

Participant Groups

Group I: ABC008 Dose Level 5 Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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 Cohort Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Abcuro, Inc.

Lead Sponsor

Trials

4

Recruited

540+