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New drug ABC008 tested for rare blood cancer

NCT ID NCT05532722

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called ABC008 in 21 adults with T-cell large granular lymphocytic leukemia (T-LGLL), a rare blood cancer. The drug was given as a shot under the skin. The main goal was to check for side effects and see how the drug affects blood counts and other lab values.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABC008
What this could lead to
If successful, this could point toward a new treatment option for T-LGLL, a rare leukemia that affects blood cell counts.
What could go wrong
This is an early-phase trial with only 21 participants, so results may not apply to all patients. The main focus is safety, not yet effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

21 people

The number who actually took part.

Started

Sep 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Leukemia, Large Granular Lymphocytic T-cell large granular lymphocyte leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.