A Phase 1/2, Open-Label, First-in-Human, Multiple Ascending Dose Multicenter Study of MT-101 in Subjects with CD5+ Relapsed/ Refractory Peripheral T Cell Lymphoma
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: Open
Phase: I/II
Principal Investigator: Lunning, Matthew
Eligibility: https://clinicaltrials.gov/ct2/show/NCT05138458?term=NCT05138458&draw=2&rank=1#eligibility
Summary
Phase 1 portion
Primary Objective: to evaluate the safety and tolerability of MT-101 in subjects with CD5+ r/r PTCL at Day 28, and to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), based on observed adverse events (AEs) including all potential dose limiting toxicities (DLTs).
Secondary Objective:Determine MT-101 cell kinetics in the blood; Determine the objective response rate (ORR) (Complete Response [CR] + Partial Response [PR]) according to the Lugano Classification Criteria (Cheson 2014) at 6 months; Determine the duration of response (DOR); Determine Progression Free Survival (PFS); Determine Overall Survival (OS) ; Determine rate of grade 3-5 Cytokine Release Syndrome (CRS); Determine rate of immune effector cell-associated neurotoxicity syndrome (ICANS).
Exploratory Objectives: Assess the development of anti-drug antibodies (ADA) to MT-101 ; Determine the heterogeneity of CD5 expression in tumors to identify potential biomarkers of response; Determine the treatment-related effects of cytokine and chemokine production, T cell receptor (TCR) expansion and cell phenotype in the blood to identify potential biomarkers of response; Determine the treatment-related effects to tumor architecture and cell phenotype to identify potential biomarkers of response.
Phase 2 Portion
Primary Objective: The primary objective of the Phase 2 portion of the study is to determine the ORR (CR + PR) according to the Lugano Classification Criteria (Cheson 2014) in subjects with CD5+ r/r PTCL.
Secondary Objectives: Determine the duration of response (DOR); Determine the percent of subjects with a CR at 24 weeks; Determine the percent of subjects with a PR at 24 weeks ; Determine the percent of subjects with stable disease (SD) at 24 weeks; Determine PFS; Determine OS; Further assess the safety and tolerability of MT-101.
Exploratory Objectives: Assess quality of life (QOL) by the EuroQol (EQ-5D) questionnaire