Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
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. OUTLINE: Patients receive teclistamab subcutaneously (SC) on days 1, 4, and 7 in the absence of disease progression or unacceptable toxicity (i.e., Cycle 1). Beginning 1 week later, patients receive teclistamab SC on day 1 (i.e., Cycle 2). Beginning 1 week later, 2 weeks later, or 4 weeks later (based on dose level), patients receive teclistamab SC 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
