NCT04601584

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

Dose-escalation Sequention Cohort Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNR-084 in Patients With Refractory or Relapse Acute Lymphoblastic B-cell Precursor Leukemia.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Acute lymphoblastic leukemias (ALL) are a heterogeneous group of malignant clonal diseases of the blood system originating from precursor cells of hematopoiesis, predominantly of lymphoid differentiation. More than 7,200 new cases of ALL are diagnosed annually in the European Union (EU), with approximately 40% (approximately 3,000 cases) occurring in adults The main reason for the failure of treatment of acute B-cell lymphoblastic leukemias (B-ALL) is the primary refractoriness to chemical exposure and relapses of the disease, which actually occur in 40-50% of adult patients with ALL. The prognosis in these cases is regarded as extremely unfavorable. Escalation of the chemotherapeutic approach is associated with the development of severe toxic infectious and hemorrhagic complications. The active substance of the preparation GNR-084 is a bispecific antibody to CD19 / CD3 in the BiMS format (bispecific IgG-like molecules).

Conditions

• B-precursor Acute Lymphoblastic Leukemia
• ALL
• GNR-084

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-10-15
• Primary completion: 2025-02-01
• Completion: 2025-06-01
• First posted: 2020-10-26
• Last updated: 2024-03-06

Locations

3 sites across 1 country: Russia