Phase II Study of Dual Targeting of CD19 and CD20 Antigens Using Sequential CD19-directed CAR-T Cells Followed by Mosunetuzumab or Glofitamab in Relapsed or Refractory Diffuse Large B-cell or Transformed Follicular Lymphomas
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Lymphoma/CLL (ONC)
Current Status: Not open
Phase: II (Cancer Control)
Principal Investigator: Lunning, Matthew
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04889716?term=NCT04889716&rank=1#participation-criteria
Summary
The primary objective is to evaluate the safety and efficacy of early administration of single agent mosunetuzumab (Cohort 1) or glofitamab (Cohort 2) after CD19-directed CAR-T cells in patients with relapsed or refractory (r/r) LBCL. Efficacy will be measured by complete response rate at 24 weeks (± 2 weeks) after cycle 1 day 1 of study therapy, as defined by Cheson et al. 2014.41
Secondary:
The secondary objectives of this study are to assess additional efficacy endpoints, including progression-free survival (PFS), response duration (RD) and overall survival (OS) for subjects treated with early administration of single agent mosunetuzumab or glofitamab after CD19-directed CAR-T cells in r/r LBCL. Please see Section 7 for more details regarding efficacy endpoints.
Additional secondary objectives include:
1. Evaluate the impact of bispecific antibody treatment after standard-of-care therapy with CD19-directed CAR T-cells on systemic soluble immune factors, immune cell phenotype, and immune cell gene-expression in subjects
2. Evaluate MRD using molecular technologies
Exploratory:
1. To evaluate the immunologic effects of mosunetuzumab and glofitamab exposure on CAR-T cells, including but not limited to assessment of CAR-T cell expansion in vivo, activation state of CAR-T cells during expansion in vivo, and circulating cytokine levels during early sequential therapy.
2. To make a preliminary assessment of biologic markers that might predict adverse events during sequential administration of CAR-T cells and mosunetuzumab or glofitamab.
3. To make a preliminary assessment of biologic markers that might act as predictors of anti-tumor activity during sequential administration of CAR-T cells and mosunetuzumab or glofitamab, including, but not limited to circulating cell-free tumor DNA and radiologic assessments.