Trials / Recruiting
RecruitingNCT05453396
Loncastuximab Tesirine for the Treatment of Relapsed or Refractory B-Cell Malignancies
A Pilot Study of Loncastuximab Tesirine in Specific Populations of Relapsed/Refractory B-Cell Malignancies
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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. After completion of study treatment, patients are followed up for 5 years.
Conditions
- Post-Transplant Lymphoproliferative Disorder
- Recurrent B-Cell Non-Hodgkin Lymphoma
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Neoplastic Post-Transplant Lymphoproliferative Disorder
- Refractory B-Cell Non-Hodgkin Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Follicular Lymphoma
- Refractory Mantle Cell Lymphoma
- Refractory Neoplastic Post-Transplant Lymphoproliferative Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Loncastuximab Tesirine | Given IV |
Timeline
- Start date
- 2023-08-07
- Primary completion
- 2026-12-15
- Completion
- 2027-07-06
- First posted
- 2022-07-12
- Last updated
- 2025-10-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05453396. Inclusion in this directory is not an endorsement.