Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 29, 2020

Primary Completion Date

July 15, 2024

Study Completion Date

February 24, 2025

Conditions
Acute Lymphoblastic Leukemia RecurrentAcute Lymphoblastic Leukemia, in RelapseAcute Myeloid Leukemia, in RelapseAcute Myeloid Leukaemia RecurrentMixed Phenotype Acute Leukemia
Interventions
DRUG

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

Trial Locations (3)

13009

Institut Paoli-Calmettes, Marseille

33604

Chu Bordeaux Hopital Haut Leveque, Pessac

Unknown

IUCT, Toulouse

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

INATHERYS

UNKNOWN

lead

Institut Paoli-Calmettes

OTHER