Phase 1b Study of Teclistamab in Relapsed/Refractory Plasmablastic Lymphoma
National Cancer Institute (NCI)
Summary
This phase Ib trial tests the safety, side effects, and best dose 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 and tolerable in treating patients with recurrent or refractory plasmablastic lymphoma.
Description
PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose (RP2D) 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. OUTL…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed R/R PBL * Patients must have measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest dimension * Patients should have ≥ 1 line of prior therapy. This includes at least 1 prior line of chemotherapy or radiation * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of teclistamab in patients \< 18 years…
Interventions
- ProcedureBiospecimen Collection
Undergo buccal swab and blood sample collection
- ProcedureComputed Tomography
Undergo PET/CT
- ProcedurePositron Emission Tomography
Undergo PET/CT
- DrugTeclistamab
Given SC
Location
- City of Hope Comprehensive Cancer Center LAODuarte, California