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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05453396
Phase
PHASE2
Status
Terminated

Conditions

  • 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab Tesirine — BIOLOGICAL
    Given IV
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy and aspiration
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy and aspiration

Study Details

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.

Key Dates

Start date
Aug 7, 2023
Status verified
Jun 2026
Primary completion
May 5, 2026
Completion
May 21, 2026

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

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