Cure My Disease

Don't miss your cure!

 Log in / Sign up

Liver-Friendly lymphoma treatment? new drug dosing study offers hope

NCT ID NCT05660395

Disease control Sponsor: ADC Therapeutics S.A. Source: ClinicalTrials.gov ↗

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests the safety and best dose of loncastuximab tesirine, a targeted antibody-drug conjugate, in people with relapsed or refractory diffuse large B-cell lymphoma or high-grade B-cell lymphoma who also have moderate or severe liver impairment. The goal is to find a dosing regimen that works for these patients, who are often excluded from clinical trials. Only 5 participants are enrolled in this early-stage, open-label study.

What this could mean

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

Active substance
loncastuximab tesirine (Zynlonta), an antibody-drug conjugate given by IV infusion
What this could lead to
If successful, this study could help determine safe and effective dosing of loncastuximab tesirine for lymphoma patients with liver problems, expanding treatment options for this group.
What could go wrong
This is a very early, small Phase 1b study with only 5 participants, so results may not apply broadly. Liver impairment can increase drug toxicity risks.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

5 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 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: * Male or female participants aged 18 years or older * Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen * Measurable disease as defined by the 2014 Lugano Classification * Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification: * Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN) * Arm B Moderate hepatic impairment: bilirubin \> 1.5 × to 3 × ULN (any AST) * Arm C Severe hepatic impairment: bilirubin \> 3 × ULN (any AST) * ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment * Adequate organ function * Women of childbearing potential (WOCBP)\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug. Exclusion Criteria: * Previous therapy with loncastuximab tesirine * Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1) * Human immunodeficiency virus (HIV) seropositive * Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load * Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load * History of Stevens-Johnson syndrome or toxic epidermal necrolysis * Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease * Breastfeeding or pregnant * Significant medical comorbidities * Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diffuse large B-cell lymphoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma high grade B-cell lymphoma lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma High-grade B-cell lymphoma

Contacts and locations

Locations

  • A Beneficência Portuguesa de São Paulo - Unidade Mirant

    São Paulo, 01323-030, Brazil

  • Albert Einstein Israelite Hospital

    São Paulo, 05652-900, Brazil

  • Dong-A University Hospital

    Pusan, Gyeongsangnam-do, 602-812, South Korea

  • Hospital 9 de Julho

    São Paulo, 01409-002, Brazil

  • Hospital Mãe de Deus - Centro Integrado de Oncologia

    Porto Alegre, 90110-270, Brazil

  • Hospital Sírio-Libanês - Brasília

    Brasília, 70200-730, Brazil

  • Hospital Sírio-Libanês - São Paulo

    São Paulo, 01308-050, Brazil

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, Taiwan 112, Taiwan

  • Korea University Anam Hospital

    Seoul, Seongbuk District, 02841, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, Daegu Gwang'yeogsi, 41944, South Korea

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080, South Korea

  • Severance Hospital

    Seoul, Seoul Teugbyeolsi, 03722, South Korea

  • The Oncology Institute of Hope & Innovation - Lynwood

    Lynwood, California, 90262, United States

More trials for these conditions

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