Testing the Effect of Teclistamab on Recurrent Plasmablastic Lymphoma
Trial statusRecruiting
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 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo buccal swab and blood sample collection
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Teclistamab
DrugGiven SC
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Treatment (teclistamab)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Incidence of adverse events
Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. and American Society for Transplantation and Cellular Therapy/Immune Effector Cell Associated Neurotoxicity Syndrome criteria/grading. Descriptive statistics will be employed in the analysis of all safety observations in this study.
Time frame
Up to 28 days after last dose of study treatmentSecondary outcomes
1
Overall response rate (ORR)
Will be assessed by the 2014 Lugano Response Criteria (Cheson et al., 2014). An alternative hypothesis of 40% ORR versus a null hypothesis of 10% will be tested in the dose-expansion cohort. A Simon's Two-Stage Minimax design (Simon, 1989) will be applied to test the hypothesis.
Time frame
Up to 2 years after last dose of study treatment2
Complete response rate
Will be assessed by the 2014 Lugano Response Criteria (Cheson et al., 2014).
Time frame
Up to 2 years after last dose of study treatment3
Progression-free survival (PFS)
PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. 95% confidence intervals will be constructed based on log-log transformation.
Time frame
From start of protocol treatment to time of progressive disease/relapse or death due to any cause, whichever occurs earlier, assessed up to 2 years4
Overall survival (OS)
OS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. 95% confidence intervals will be constructed based on log-log transformation.
Time frame
From start of protocol treatment to time of death due to any cause, assessed up to 2 yearsOther outcomes
1
Utility of B-cell maturation antigen (BCMA) as a biomarker of response
Archival pre-treatment formalin fixed and paraffin embedded tumor samples will be stained with a BCMA immunohistochemistry (IHC) antibody (clone E6D7B) and an H-score will be determined by an expert hematopathologist. Associations between BCMA IHC H-score and response to teclistamab will be determined using a Fisher's exact test at an H-score cutoff of 100.
Time frame
Up to 2 years after last dose of study treatment2
Impact of minimum residual disease (MRD) on PFS
Impact will be determined by a cycle 3 circulating tumor deoxyribonucleic acid level on 2-year PFS. The Kaplan-Meier method will be used to estimate PFS and a log-rank test will be used to compare the PFS between MRD-positive and MRD-negative groups.
Time frame
Up to 2 years after last dose of study treatmentSponsors and contacts
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Source ClinicalTrials.gov