At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Loncastuximab Tesirine (drug), Polatuzumab Vedotin (drug), Glofitamab (drug), Mosunetuzumab (drug)
- How long the study runs
- Study runs about 70 months (dates as stated)
- About the drug or intervention
- Loncastuximab Tesirine — drug: Intravenous (IV) infusion · Polatuzumab Vedotin — drug: IV infusion · Glofitamab — drug: IV infusion · Mosunetuzumab — drug: Subcutaneous (SC) injection · Obinutuzumab — drug: IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 154
- Started
- 2022-06-17
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for b-cell non-hodgkin lymphoma
- • Phase1 - 154 participants
- • The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with b-cell non-hodgkin lymphoma
Where?
- • London - University College London Hospitals NHS Foundation Trust
- • Oxford - Oxford University Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab, and to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combinations.
More detail
This is a Phase 1b, multi-center, open-label, multi-arm study to evaluate the safety and anti-cancer activity of loncastuximab tesirine in combination with polatuzumab vedotin, glofitamab, or mosunetuzumab in participants with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL). Loncastuximab tesirine (ADCT-402; Zynlonta) is an antibody drug conjugate (ADC), composed of a humanized monoclonal antibody directed against human cluster of differentiation 19 (CD19) conjugated through a cathepsin-cleavable linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Loncastuximab tesirine has been granted by Food and Drug Administration (FDA) as accelerated approval for adult participants with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (HGBCL). In the European Union (EU), the European Commission (EC) granted conditional approval for the treatment of adult patients with relapsed or refractory DLBCL and HGBCL, after two or more lines of systemic therapy. The study includes multiple arms in two parts, Dose Escalation part (Part 1) and Dose Expansion part (Part 2). In Part 1, for the arm of loncastuximab tesirine in combination with polatuzumab vedotin includes DLBCL, HGBCL, follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and Burkitt lymphoma (BL); for the arms of loncastuximab tesirine in combination with glofitamab or mosunetuzumab include DLBCL, HGBCL, FL, and MZL. In Part 2, participants will be treated at the dose level(s) determined from Part 1. The Sponsor will conduct the safety monitoring and the overall supervision of the study in consultation with the Dose-Escalation Steering Committee (DESC)/Data Safety Monitoring Committee (DSMC). For each participant, the study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 21 days), and a Follow-up Period (approximately every 12 week visits for up to two years for Arm C and three years for Arms E and F). Participants may continue treatment for up to one year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. Treatment with gemcitabine (Arm A), lenalidomide (Arm B), and umbralisib (Arm D) were removed.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ received at least one line of systemic therapy post-transformation to be eligible)
What the study is looking for
- ✓Male or female participant aged 18 years or older
- ✓Part 2 Arm E enrollment focused on LBCL only
- ✓DLBCL, not otherwise specified (NOS)
- ✓Germinal Center B-cell type
- ✓Activated B-cell type
Who cannot take part
- ✗Known history of hypersensitivity resulting in treatment discontinuation to or positive serum human ADA to a CD19...
- ✗Previous therapy with loncastuximab tesirine
- ✗Previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab (applied to relevant arm and/or cohort of...
- ✗Participants who received previous treatment of polatuzumab vedotin containing regimen will be excluded from Arm C
- ✗Human immunodeficiency virus (HIV) seropositive
See the full criteria
Where Is This Study? (2 UK sites)
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Oxford University Hospitals NHS Foundation Trust
Oxford OX3 7LE, United Kingdom
