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

Trial Title: ABC008 in Subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL)

NCT ID: NCT05532722

Condition: T-cell Large Granular Lymphocytic Leukemia

Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Large Granular Lymphocytic

Conditions: Keywords:
T-cell Large Granular Lymphocytic Leukemia
T-LGLL

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ABC008
Description: Given subcutaneous injection
Arm group label: ABC008 Dose Level 1 Cohort
Arm group label: ABC008 Dose Level 2 Cohort
Arm group label: ABC008 Dose Level 3 Cohort
Arm group label: ABC008 Dose Level 4 Cohort
Arm group label: ABC008 Dose Level 5 Cohort

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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). Exclusion Criteria: - 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. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: City of Hope

Address:
City: Duarte
Zip: 91010
Country: United States

Facility:
Name: University of Southern California

Address:
City: Los Angeles
Zip: 90033
Country: United States

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Facility:
Name: Dana-Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Facility:
Name: Icahn School of Medicine at Mount Sinai

Address:
City: New York
Zip: 10029
Country: United States

Facility:
Name: Cleveland Clinic Foundation

Address:
City: Cleveland
Zip: 44195
Country: United States

Facility:
Name: The University of Texas M.D. Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Huntsman Cancer Institute, University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Start date: September 28, 2022

Completion date: September 2027

Lead sponsor:
Agency: Abcuro, Inc.
Agency class: Industry

Source: Abcuro, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05532722