Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07332507
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Recurrent Plasmablastic Lymphoma
  • Refractory Plasmablastic Lymphoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo buccal swab and blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Teclistamab — DRUG
    Given SC

Study Details

This phase Ib trial tests the safety, side effects, and best dose, as well as the effectiveness of teclistamab in treating patients with plasmablastic lymphoma that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving teclistamab may be safe, tolerable, and/or more effective than usual treatment with radiation or chemotherapy in treating patients with recurrent or refractory plasmablastic lymphoma.

Key Dates

Start date
May 29, 2026
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (teclistamab)
    Patients receive teclistamab SC on days 1, 4, and 7 of cycle 1 and on day 1 of remaining cycles. Based on dose level, cycles repeat weekly, every 2 weeks or every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who have achieved a CR by cycle 13 may discontinue study treatment. Patients achieving less than a CR but benefiting from treatment may continue to receive teclistamab beyond 13 cycles in the absence of disease progression, unacceptable toxicity, or achieving a CR. Additionally, patients undergo optional buccal swab collection at baseline and optional blood sample collection throughout the study. Patients also undergo PET/CT throughout the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 28 days after last dose of study treatment ]

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