A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: I
Principal Investigator: D'Angelo, Christopher
Contact Information:
Maribeth Hohenstein, RN
402-559-9053
mahohens@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04860466?term=NCT04860466&rank=1
Summary
Primary
To determine the safety and tolerability of CC-96673
 To define the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of CC-96673
Secondary
To provide information on the preliminary efficacy of CC-96673 in R/R NHL
 To characterize the pharmacokinetics (PK) of CC-96673
 To evaluate the presence, frequency, and functional impact of anti-CC-96673 antibodies (anti-drug antibodies [ADA])
Exploratory
To evaluate pharmacodynamic (Pd) markers of CC-96673 activity in peripheral blood (eg, the assessment of cytokines/chemokines, activation of myeloid and NK cells and B cell aplasia)
 To evaluate baseline tumor biomarkers as potential predictors of response to CC-96673 including immune cell and tumor cell expression of potential biomarkers of interest (eg, CD20, CD47, and SIRPα)
 To evaluate the impact of CC-96673 on gene expression and the tumor microenvironment
using paired tumor biopsies (pre- and post-treatment)
 To evaluate circulating cell-free DNA (cfDNA) for mutations associated with resistance to CC-96673
 To evaluate the relationship between dose, systemic exposure of CC-96673, ADAs, Pd
biomarkers, and clinical activity
 To assess the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic status on subjects with NHL receiving CC-96673