Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)
About this trial
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.
Eligibility criteria
Qualifiers
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 of age, children are excluded from this study
Disqualifiers
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia and peripheral neuropathy
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to teclistamab
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Computed Tomography
- Positron Emission Tomography
- Teclistamab
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov