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.

NCT04601584 Phase 1/Phase 2 UNKNOWN

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

Details

Lead sponsor	AO GENERIUM
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	36
Start date	2020-10-15
Completion	2025-06

Conditions

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

Interventions

• Cohort 1, GNR-084
• Cohort 2, GNR-084
• Cohort 3, GNR-084
• Cohort 4, GNR-084
• Cohort 5, GNR-084
• Cohort 6, GNR-084

Primary outcomes

• GNR-084 safety and tolerability. — Week 10
  The GNR-084 safety and tolerability will be assessed based on an analysis of the frequency of adverse events (AEs) over the period of treatment and observation of patients

Countries

Russia