OncoMatch/Clinical Trials/NCT04601584
GNR-084 Safety and Pharmacological Characteristics in Refractory or Relapse B-cell Precursor ALL
Is NCT04601584 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for b-precursor acute lymphoblastic leukemia.
Treatment: Cohort 1, GNR-084 · Cohort 2, GNR-084 · Cohort 3, GNR-084 · Cohort 4, GNR-084 · Cohort 5, GNR-084 · Cohort 6, GNR-084 — It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-084.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive
CD19-positive acute lymphoblastic leukemia
Allowed: BCR fusion
Ph "-" or Ph "+"
Allowed: ABL1 fusion
Ph "-" or Ph "+"
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-leucosis therapy
Two or more previous lines of anti-leucosis therapy.
Cannot have received: hematopoietic stem cell transplant
Hematopoietic stem cells transplantation within 12 weeks prior to study inclusion
Cannot have received: chemotherapeutic agent
Exception: Emergency leukapheresisEmergency hydroxyurea using due to hyperleukocytosis for ≤ 7 daysOther supportive care, including antibiotics, at Investigator's discretion
Chemotherapeutic agent using within 14 days prior the first GNR-084 infusion
Cannot have received: bispecific antibody (blinatumomab)
Medical history of blinatumomab and other bispecific antibodies using
Lab requirements
Kidney function
Glomerular filtration rate (GFR) level ≤30 (CKD-EPI) [excluded]
Liver function
The level of total bilirubin > 1.5 upper limit of norm; AST and ALT > 3 upper limit of norm [excluded]
Cardiac function
Severe cardiovascular diseases: uncontrolled arterial hypertension, NYHA class III or IV chronic heart failure, unstable angina pectoris, stroke, myocardial infarction, transient ischemic attack, coronary artery bypass grafting and coronary revascularization within last 12 months, or signs of pericardial effusion [excluded]
Biochemical blood test: The level of total bilirubin > 1.5 upper limit of norm; AST and ALT > 3 upper limit of norm; GFR ≤30 (CKD-EPI); Severe cardiovascular diseases: uncontrolled arterial hypertension, NYHA class III or IV chronic heart failure, unstable angina pectoris, stroke, myocardial infarction, transient ischemic attack, coronary artery bypass grafting and coronary revascularization within last 12 months, or signs of pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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