GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

October 15, 2020

Primary Completion Date

February 28, 2025

Study Completion Date

June 30, 2025

Conditions
B-precursor Acute Lymphoblastic LeukemiaALLGNR-084
Interventions
BIOLOGICAL

Cohort 1, GNR-084

0.01 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

BIOLOGICAL

Cohort 2, GNR-084

0.1 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

BIOLOGICAL

Cohort 3, GNR-084

1 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

BIOLOGICAL

Cohort 4, GNR-084

4 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

BIOLOGICAL

Cohort 5, GNR-084

10 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

BIOLOGICAL

Cohort 6, GNR-084

20 ng/kg 6-hours intravenous infusion once a week; 4 doses per cycle, up to 5 cycles

Trial Locations (3)

125167

RECRUITING

Federal State Budget Funded Institution National Medical Research Center of Hematology, Ministry of Health of the Russian Federation (MoH of Russia), Moscow

191014

RECRUITING

Almazov National Medical Research Centre, Saint Petersburg

197022

RECRUITING

Pavlov First Saint Petersburg State Medical University, Saint Petersburg

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY