A PHASE 1 DOSE ESCALATION AND EXPANDED COHORT STUDY OF P-MUC1C-ALLO1 IN ADULT SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
Categories (click each to see list of all clinical trials associated with that category): Breast (ONC), Cellular Therapy Support Service - CAR-T (ONC), GI (ONC), GU (ONC), Gyn/Onc (OB/GYNONC), Thoracic (ONC)
Current Status: Open
Phase: I (Cancer Control)
Principal Investigator: Ganti, Apar
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05239143?term=NCT05239143&draw=2&rank=1#eligibility
Summary
Primary
Part 1
To determine the MTD and/or RP2D of P-MUC1C-ALLO1 based on DLTs.
To evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1.
Part 2
To confirm the safety and tolerability of the RP2D.
To further evaluate the preliminary efficacy of P-MUC1C-ALLO1.
Secondary
Part 1/Part 2
The preliminary efficacy of P-MUC1C-ALLO1.
The effect of cell dose to guide selection of doses for further assessment in Phase 2/3 studies.
Exploratory
Evaluate the relationship between tumor MUC1-C expression, other biomarkers, and clinical response.
Characterize the expansion and functional persistence of P-MUC1C-ALLO1 cells.
Evaluate the relationship between putative CRS markers and efficacy or safety.
Explore the impact on QoL parameters.
Evaluate the effect of rimiducid on P-MUC1C-ALLO1 related AEs, if indicated