33
Participants
Start Date
May 29, 2020
Primary Completion Date
July 15, 2024
Study Completion Date
February 24, 2025
INA03 administration
INA03 will be administered IV on Day 1, Day 14 of 28-day cycles. The administration of INA03 will begin at 0.02 mg/kg. Study Part I is a titration study to determine the dose for the first INA03 infusion. Patients will be enrolled in sequential cohorts of 2 patients to receive ascending starting doses of INA03, starting from the lowest starting dose (0.02 mg/kg), and followed by subsequent administrations of INA03 (D14 and beyond) at a fixed dose of 0.1 mg/kg. The starting dose will be increased every cohort of 2 patients until evidence of absence of marrow residual erythroblasts by D14 myelogram. This dose is referred to as the MEID and will be selected as the D1 dose for the study Part 2. Patient accumulation in Part I of the study will continue until no evidence of non-hematological DLT within 28 days post dosing
Institut Paoli-Calmettes, Marseille
Chu Bordeaux Hopital Haut Leveque, Pessac
IUCT, Toulouse
Collaborators (1)
INATHERYS
UNKNOWN
Institut Paoli-Calmettes
OTHER