ABC008 for Large Granular Lymphocytic Leukemia
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.12345Why 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.13456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive escalating doses of ABC008 every 4 to 8 weeks until completion of cohort 5 or determination of maximum tolerated dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
5
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abcuro, Inc.
Lead Sponsor
Citations
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)
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-commencesPhase 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.
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-leukemiaA 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) ...
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 ...
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