T-cell Large Granular Lymphocytic LeukemiaPhase 1/2NCT05532722
ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
A Phase 1/2 study testing ABC008 in people with T-cell Large Granular Lymphocytic Leukemia, run by Abcuro, Inc. at 8 sites in United States.
Trial summary
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T-cell Large Granular Lymphocytic Leukemia
- What is being tested?
- ABC008
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Sep 2022to 31 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is at least 18 years of age.
- Has body mass index (BMI) ≤35 kg/m2.
- Has a documented diagnosis of T LGLL.
- Has any 1 or more of the following at Screening:
- Absolute neutrophil count (ANC) <0.5 x 109/L
- ANC ≥0.5 x 109/L and <1.0 x 109/L associated with recurrent infection (≥2 or more infections requiring antimicrobial therapy within the previous 12 months)
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- Hemoglobin (Hgb) <8 g/dL or packed red blood cell transfusion frequency ≥1 time in the 4 weeks immediately prior to Screening
- Hgb ≥8 g/dL and <10 g/dL accompanied by documented symptoms of anemia, e.g., fatigue, weakness, pale or yellowish skin, irregular heartbeat, shortness of breath, dizziness, or lightheadedness.
- Has adequate hepatic and renal function at Screening, as indicated by:
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST); <2.5x the upper limit of normal (ULN)
- Total bilirubin ≤1.5 ULN; subjects with Gilbert syndrome must have a total bilirubin <3.0x ULN with direct bilirubin <1.0x ULN at time of Screening
- Estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation corrected for the body surface area of the subject calculated by the Mosteller equation and divided by 1.73
- 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).
Who cannot join
- Has reactive large granular lymphocytosis.
- Has active anemia secondary to confirmed etiologies other than T-LGLL, including known vitamin or mineral deficiency, gastrointestinal bleeding, or genetic disorder; or has active neutropenia secondary to known vitamin or mineral deficiencies or genetic disorder.
- Has a platelet count ≤20 x 109/L or other clinically significantly abnormal laboratory results not related to the underlying condition in the Investigator's or Sponsor's opinion at Screening.
- Has known hypersensitivity to any component of the formulation of ABC008, or history of anaphylaxis to any prior mAb therapy.
- Has any other autoimmune or autoinflammatory disease other than RA, inclusion body myositis (IBM), secondary Sjogren's syndrome (SS), or thyroid disease.
- Has another myelo /lympho proliferative disorder or malignancy (other than monoclonal gammopathy of unknown significance [MGUS] not requiring treatment) within the past 5 years prior to Screening except completely resected nonmelanoma skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ at any site.
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- Has a current diagnosis of active tuberculosis (TB)
- Has a history of herpes zoster infection that was disseminated, required hospitalization, or IV antiviral therapy in the 24 weeks prior to Day 1.
- Active, chronic, or past history of hepatitis B virus or hepatitis C virus (HCV) infection (hepatitis B core antibody or surface antigen positive, or HCV antibody positive with reflex HCV ribonucleic acid [RNA] positive at Screening; individuals who have received curative therapy for HCV are permitted if therapy was completed at least 24 weeks prior to Screening and subject is HCV RNA negative);
- Has known active bacterial, viral, fungal, or atypical mycobacterial infection, or any major episode of infection that required hospitalization
- Has received live (including attenuated) vaccination in the 30 days prior to Day 1 or killed vaccine within 14 days prior to Day 1.
- Is human immunodeficiency virus (HIV) positive by antigen/antibody test, human T cell lymphotropic virus (HTLV 1 or 2) positive by antibody test.
- Has had major surgery (defined as surgery requiring general or regional anesthesia) within 6 weeks prior to Day 1 or is expected to receive surgery during the study.
- Has a history of organ transplant (e.g., solid, bone marrow) or is expected to receive one during the study.
- Has any other condition or social situations that would interfere with the subject's study participation, increase the risk associated with study participation or investigational product administration, interfere with the interpretation of study results, or would otherwise make the subject inappropriate for entry into this study in the Investigator's or Sponsor's opinion.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
City of Hope
Duarte, California, 91010
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: A Study of ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
- Being tested
- ABC008
- Keywords
- T-cell Large Granular Lymphocytic Leukemia, T-LGLL
- Medical subject headings
- Leukemia, Large Granular Lymphocytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABC008Drug
Given subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| ABC008 Dose Level 1 Cohort | Experimental | 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. Receives: Drug: ABC008 |
| ABC008 Dose Level 2 Cohort | Experimental | 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. Receives: Drug: ABC008 |
| ABC008 Dose Level 3 Cohort | Experimental | 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. Receives: Drug: ABC008 |
| ABC008 Dose Level 4 Cohort | Experimental | 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. Receives: Drug: ABC008 |
| ABC008 Dose Level 5 Cohort | Experimental | 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. Receives: Drug: ABC008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0
Measured: Through Study Completion an average of 48 weeks
Secondary outcomes (28)
Change from baseline in safety lab (Hematology)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Chemistry)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Coagulation)
Includes the following coagulation labs: INR and aPTT
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Complement)
Includes the following complement labs: C3 and CH50
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Cytokines)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (CMV Viral Load)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (EBV Viral Load)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in ECG (Rhythm)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in ECG (Heart Rate)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in ECG parameters
Includes the following ECG parameters: RR interval, PR interval, QRS interval, QT interval, QT interval corrected by Bazett's formula, and QTcF
Measured: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (Systolic and diastolic blood pressure)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (temperature)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (respiratory rate)
Measured: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (pulse rate)
Measured: Through Study Completion an average of 48 weeks
Percentage of subjects demonstrating overall response (defined as total number of subjects with CR or PR) at all time points assessed
Measured: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating complete response at all time points assessed
A complete response is defined by normalization of hemoglobin, neutrophil and platelet levels without transfusion
Measured: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating partial response at all time points assessed
A partial response is defined by improvement in any of the following criteria but not all: hemoglobin, neutrophil and platelet levels without transfusion
Measured: Day 1 and throughout the 48 weeks of follow up
Duration of response at all time points assessed
Measured: Day 1 and throughout the 48 weeks of follow up
Overall survival at Week 48
Measured: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of KLRG1 expressing lymphocytes over time
Measured: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of T-LGL counts over time
Measured: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of lymphocyte subsets over time
Measured: Day 1 and throughout the 48 weeks of follow up
The maximum serum concentration [CMax] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
The time to maximum concentration [TMax] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
The area under the concentration-time curve [AUC] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
The apparent clearance [CL/F] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
The apparent volume of distribution [Vd/F] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
The elimination half-life [t½] of ABC008
Measured: Day 1 and throughout the 48 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start28 Sep 2022
- Primary completion28 Aug 2025
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Large Granular Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abcuro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532722
- Sponsor's protocol ID
- ABC008-LGL-101
- Status last verified
- May 2026
- First submitted
- 19 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
- ClinicalTrials.gov ID
- NCT05532722
- Acronym / sponsor ID
- ABC008-LGL-101
- Keywords
- T-cell Large Granular Lymphocytic Leukemia, T-LGLL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Abcuro, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ABC008 Dose Level 1 Cohort | Experimental | Drug: ABC0080.25 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. |
| ABC008 Dose Level 2 Cohort | Experimental | Drug: ABC0080.75 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. |
| ABC008 Dose Level 3 Cohort | Experimental | Drug: ABC0081.5 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. |
| ABC008 Dose Level 4 Cohort | Experimental | Drug: ABC0083.0 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. |
| ABC008 Dose Level 5 Cohort | Experimental | Drug: ABC0083.0 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Is at least 18 years of age.
- Has body mass index (BMI) ≤35 kg/m2.
- Has a documented diagnosis of T LGLL.
- Has any 1 or more of the following at Screening:
- Has adequate hepatic and renal function at Screening, as indicated by:
Key exclusion criteria (15 listed)
- Has reactive large granular lymphocytosis.
- Has active anemia secondary to confirmed etiologies other than T-LGLL, including known vitamin or mineral deficiency, gastrointestinal bleeding, or genetic disorder; or has active neutropenia secondary to known vitamin or mineral deficiencies or genetic disorder.
- Has a platelet count ≤20 x 109/L or other clinically significantly abnormal laboratory results not related to the underlying condition in the Investigator's or Sponsor's opinion at Screening.
- Has known hypersensitivity to any component of the formulation of ABC008, or history of anaphylaxis to any prior mAb therapy.
- Has any other autoimmune or autoinflammatory disease other than RA, inclusion body myositis (IBM), secondary Sjogren's syndrome (SS), or thyroid disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABC008Given subcutaneous injection | Drug | ABC008 Dose Level 1 Cohort, ABC008 Dose Level 2 Cohort, ABC008 Dose Level 3 Cohort, ABC008 Dose Level 4 Cohort, ABC008 Dose Level 5 Cohort |
Primary outcome
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0
Time frame: Through Study Completion an average of 48 weeks
28 secondary outcomes
Change from baseline in safety lab (Hematology)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Chemistry)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Coagulation)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Complement)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (Cytokines)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (CMV Viral Load)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in safety lab (EBV Viral Load)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in ECG (Rhythm)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in ECG (Heart Rate)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in ECG parameters
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (Systolic and diastolic blood pressure)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (temperature)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (respiratory rate)
Time frame: Through Study Completion an average of 48 weeks
Change from baseline in vital sign (pulse rate)
Time frame: Through Study Completion an average of 48 weeks
Percentage of subjects demonstrating overall response (defined as total number of subjects with CR or PR) at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating complete response at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Percentage of subjects demonstrating partial response at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Duration of response at all time points assessed
Time frame: Day 1 and throughout the 48 weeks of follow up
Overall survival at Week 48
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of KLRG1 expressing lymphocytes over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of T-LGL counts over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The change from baseline in levels of lymphocyte subsets over time
Time frame: Day 1 and throughout the 48 weeks of follow up
The maximum serum concentration [CMax] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The time to maximum concentration [TMax] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The area under the concentration-time curve [AUC] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The apparent clearance [CL/F] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The apparent volume of distribution [Vd/F] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
The elimination half-life [t½] of ABC008
Time frame: Day 1 and throughout the 48 weeks of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABC008 in people with T-cell Large Granular Lymphocytic Leukemia, run by Abcuro, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, nature, and severity of treatment-emergent AEs and SAEs as determined by NCI CTCAE v5.0 (time frame: Through Study Completion an average of 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.