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

NCT04601584 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-06

No results posted yet for this study

Summary

It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.

Conditions

  • B-precursor Acute Lymphoblastic Leukemia
  • ALL
  • GNR-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

Sponsors & Collaborators

  • AO GENERIUM

    lead INDUSTRY

Principal Investigators

  • Oksana A. Markova, MD · AO GENERIUM

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2025-02-28
Completion
2025-06-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04601584 on ClinicalTrials.gov