ABC008 for Large Granular Lymphocytic Leukemia

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABC008 for individuals with T-cell Large Granular Lymphocytic Leukemia (T-LGLL), a specific type of blood cancer. The goal is to determine the safest and most effective dose of ABC008. Participants will receive varying doses of the treatment every few weeks. The trial seeks adults with T-LGLL who experience frequent infections or symptoms of anemia, such as fatigue and dizziness. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that ABC008 is likely to be safe for humans?

Research has shown that ABC008, a new treatment, may help manage T-cell Large Granular Lymphocytic Leukemia (T-LGLL). This treatment targets and reduces overactive T cells while leaving other important immune cells unharmed.

In earlier studies, researchers tested ABC008 in patients with inclusion body myositis (IBM) and reported no major safety issues. This finding suggests that ABC008 might be safe to use. However, since this trial is in its early stages, the main goal is to assess its safety and determine the best dose for T-LGLL patients.

Although there is limited information on side effects for T-LGLL, the use of ABC008 in other trials without significant problems is promising. As with any new treatment, researchers will closely monitor participants to ensure safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABC008 because it offers a new approach to treating Large Granular Lymphocytic Leukemia (LGL). Unlike current treatments, which often involve immunosuppressive therapies like methotrexate or cyclosporine, ABC008 targets specific cellular components to modulate the immune response more precisely. This novel mechanism of action could potentially reduce the side effects associated with broader immunosuppression. Additionally, the flexibility in dosing regimens, with options ranging from every 4 to 8 weeks, might offer greater convenience and adaptability for patients.

What evidence suggests that ABC008 might be an effective treatment for T-LGLL?

Research has shown that ABC008 could be a promising treatment for T-cell Large Granular Lymphocytic Leukemia (T-LGLL). In this trial, participants will receive varying doses of ABC008 to assess its effectiveness and safety. ABC008 targets and reduces harmful T cells while sparing beneficial ones. This approach aims to control the disease by reducing aggressive cells without harming the body's natural defenses. Previous studies with similar treatments have demonstrated that targeting specific T cells can effectively manage conditions like T-LGLL. Although more information is needed, early signs suggest that ABC008 might be a helpful option for patients with T-LGLL. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05532722

NCT05532722 | ABC008 in Subjects with T-cell Large ... An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11011145/

Large Granular Lymphocytic Leukemia - PubMed Central - NIH The overall response rate (ORR) for MTX ranges from 38 to 56% [116,120,121,122], with CRR as low as 16% to 21% [43,116]. A prospective phase II study of initial ...

3. targetedonc.com targetedonc.com/view/phase-1-2-study-of-abc008-in-t-cell-large-granular-lymphocytic-leukemia-commences

Phase 1/2 Study of ABC008 in T-Cell Large Granular ... ABC008 is a first-in-class anti-KLRG1 antibody. The agent can selectively deplete highly cytotoxic T cells while also sparing regulatory T cells.

4. abcuro.com abcuro.com/clinical-trials/

Clinical Trials Abcuro has evaluated ulviprubart (ABC008) in a Phase 1 study in patients with inclusion body myositis, or IBM, at several clinics in Australia.

5. ashpublications.org ashpublications.org/blood/article/144/18/1910/516429/A-modern-view-of-LGL-leukemia

A modern view of LGL leukemia | Blood - ASH Publications Large granular lymphocytic leukemia (LGLL) is a rare lymphoproliferative chronic disorder characterized by expansion of either T or natural killer (NK) ...

6. abcuro.com abcuro.com/uncategorized/abcuro-initiates-phase-1-2-trial-evaluating-abc008-in-patients-with-t-cell-large-granular-lymphocytic-leukemia/

Abcuro Initiates Phase 1/2 Trial Evaluating ABC008 in ... ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory T cells, central memory T ...