CClinicalTrials.gg
TerminatedNCT05453396Updated Jun 15, 2026

Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies

A Phase 2 interventional study of Loncastuximab Tesirine and Bone Marrow Biopsy in Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma and Recurrent Follicular Lymphoma, sponsored by University of Washington. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Why this study was terminated
The trial closed early due to slow accrual.
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This phase II trial tests whether loncastuximab tesirine works to shrink tumors in patients with B-cell malignancies that have come back (relapsed) or does not respond to treatment (refractory). Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a chemotherapy drug, called tesirine. Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers tesirine to kill them.

Read the detailed description

OUTLINE:

Patients receive loncastuximab tesirine intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone marrow biopsy and aspiration throughout the study.

After completion of study treatment, patients are followed up for 5 years.

02

Conditions studied

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Follicular Lymphoma
  • Refractory Mantle Cell Lymphoma
03

In context

Lymphoma, B-Cell

1,411 studies on the registry are indexed under Lymphoma, B-Cell; 329 are open to participants now.

This study's enrollment of 11 is below the median of 36 across 1,218 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-Cell studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female patient aged 18 years or older
  • Disease-specific criteria:

    • Group 2: Relapsed/refractory. CD19+ B-cell non-Hodgkin lymphoma (B-NHL) excluding Waldenstrom's macroglobulinemia and marginal zone lymphoma, (at least 1 prior therapy, and no alternative with a more favorable benefit/risk ratio in the judgment of the treating investigator.
    • Group 3: CD19+ diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL) relapsing after chimeric antigen receptor (CAR) T-cell therapy or allogeneic transplant (at least 30 days from CAR T/transplant)
  • Have measurable nodal or extranodal disease, including at least 1 disease site measuring 1.5 cm in longest dimension; or splenomegaly; or histologic marrow involvement for marrow-only presentations
  • Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)
  • Absolute neutrophil count (ANC) >= 1.0 x 10\^3/uL (off growth factors at least 72 hours), unless due to marrow involvement by lymphoma in which case ANC must be >= 0.5 x 10\^3/uL
  • Platelet count >= 75 x 10\^3/uL without transfusion in the prior 7 days, unless due to disease including splenomegaly in which case platelet count must be >= 50 x 10\^3/uL
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) =\< 3 x the upper limit of normal (ULN)
  • Total bilirubin =\< 1.5 x ULN (patients with known Gilbert's syndrome may have a total bilirubin up to =\< 3 x ULN)
  • Blood creatinine =\< 2.0 x ULN or calculated creatinine clearance >= 50 mL/min by the Cockcroft and Gault equation
  • Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test within 7 days prior to start of study drug (cycle 1 day 1 [C1D1]) for women of childbearing potential
  • Women of childbearing potential 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 loncastuximab tesirine
  • Men with female partners who are of childbearing potential must agree that they will use a condom from the time of giving informed consent until at least 7 months after the patient receives his last dose of loncastuximab tesirine

Exclusion criteria

Exclusion Criteria:

  • Previous treatment with loncastuximab tesirine
  • Known history of hypersensitivity to loncastuximab tesirine
  • Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy
  • Uncontrolled graft-versus-host disease
  • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive or hepatitis B virus [HBV] deoxyribonucleic acid [DNA] detectable) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 9 months after the last dose of trial treatment
  • Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
  • Lymphoma with active central nervous system (CNS) involvement at the time of screening, including active leptomeningeal disease. A history of treated CNS disease permitted
  • Significant medical comorbidities, including but not limited to unstable angina, congestive heart failure (New York Heart Association class III or greater), uncontrolled atrial or ventricular cardiac arrhythmia, that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
  • Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1)
  • Use of any other experimental medication within 14 days prior to start of study drug (C1D1)
  • Planned live vaccine administration after starting study drug (C1D1)
  • Any other significant medical illness, abnormality, or condition that would, in the investigator's judgment, make the patient inappropriate for study participation or put the patient at risk
  • Is currently participating in a study and receiving an investigational agent or is using an investigational device within 4 weeks of the first dose of treatment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Treatment (loncastuximab tesirine)

    Patients receive loncastuximab tesirine IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo bone marrow biopsy and aspiration throughout the study.

    Biological: Loncastuximab Tesirine · Procedure: Bone Marrow Biopsy · Procedure: Bone Marrow Aspiration

Interventions

  • BiologicalLoncastuximab Tesirine

    Given IV

    Also known as: ADC ADCT-402, ADCT-402, Anti-CD19 PBD-conjugate ADCT-402, Loncastuximab Tesirine-lpyl, Zynlonta, MT 2111, MT-2111, MT2111

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow biopsy and aspiration

  • ProcedureBone Marrow Aspiration

    Undergo bone marrow biopsy and aspiration

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    According to the 2014 Lugano classification Cheson 20146 as determined by local review; ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR).

    Time frame: Up to 5 years

Secondary outcomes

  1. Rates of grade 3-5 adverse event

    Time frame: Up until 30 days after the last dose of the last study drug

  2. Rate of discontinuation due to adverse events

    Time frame: Up until 30 days after the last dose of the last study drug

  3. Clinical benefit rate

    Defined as stable disease + partial or complete response.

    Time frame: Up to 5 years

  4. Duration or response

    Time frame: Time from the first documentation of tumor response to disease progression or death, assessed up to 5 years

  5. Progression free survival

    Time frame: Time between start of treatment and the first documentation of recurrence, progression, or death, assessed up to 5 years

  6. Overall survival

    Time frame: Time between the start of treatment and death from any cause, assessed up to 5 years

  7. Incidence of grade 3-5 drug-related toxicity

    Time frame: Up until 30 days after the last dose of the last study drug

07

Study locations

1 site
  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington 98109, United States
08

References and documents

Study documents

  • Informed consent form · Oct 2, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05453396
Lead sponsor
University of Washington
Responsible party
Sponsor
First posted
Jul 12, 2022
Start date
Aug 7, 2023
Primary completion
May 5, 2026
Completion
May 21, 2026
Last update
Jun 15, 2026

Study contacts

Stephen D. Smith
principal investigator · Fred Hutch/University of Washington Cancer Consortium

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion