NCT07332507

Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma

Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the maximal tolerated dose (MTD) of teclistamab in relapsed/refractory (R/R) plasmablastic lymphoma (PBL). SECONDARY OBJECTIVES: I. To estimate the overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), and overall survival (OS) of teclistamab in R/R PBL. II. To observe and record anti-tumor activity. EXPLORATORY OBJECTIVES: I. To evaluate the utility of B-cell maturation antigen (BCMA) as a biomarker of response to teclistamab in PBL. II. To evaluate minimum residual disease (MRD) dynamics during treatment. OUTLINE: Patients receive teclistamab subcutaneously (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 complete response (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 positron emission tomography (PET)/computed tomography (CT) throughout the study. After completion of study treatment, patients are followed every 3 months for up to 2 years.

Conditions

• Recurrent Plasmablastic Lymphoma
• Refractory Plasmablastic Lymphoma

Interventions

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

Timeline

• Start date: 2026-05-29
• Primary completion: 2027-02-28
• Completion: 2027-02-28
• First posted: 2026-01-12
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study