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

NCT05532722 | Completed Phase 1 FDA Drug

• 1 other identifier: ABC008-LGL-101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

T-cell Large Granular Lymphocytic Leukemia

Keywords

T-cell Large Granular Lymphocytic Leukemia; T-LGLL

Outcome Measures

Primary Outcomes (1)

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

  Through Study Completion an average of 48 weeks

Secondary Outcomes (28)

• Change from baseline in safety lab (Hematology)

  Through Study Completion an average of 48 weeks

• Change from baseline in safety lab (Chemistry)

  Through Study Completion an average of 48 weeks

• Change from baseline in safety lab (Coagulation)

  Through Study Completion an average of 48 weeks

• Change from baseline in safety lab (Complement)

  Through Study Completion an average of 48 weeks

• Change from baseline in safety lab (Cytokines)

  Through Study Completion an average of 48 weeks

Study Arms (5)

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.

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.

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.

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.

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.

Drug: ABC008

Interventions

ABC008 DRUG

Given subcutaneous injection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Abcuro, Inc.: lead

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Leukemia, Large Granular Lymphocytic

Condition Hierarchy (Ancestors)

Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 8, 2022
• Study Start: September 28, 2022
• Primary Completion: August 28, 2025
• Study Completion: March 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (8)