OncoMatch/Clinical Trials/NCT06514768
JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)
Is NCT06514768 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies JY231 for b-cell acute lymphoblastic leukemia (b-all).
Treatment: JY231 — Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive expression
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Cannot have received: CD19-targeted therapy
Previously received treatment targeting CD19
Cannot have received: autologous hematopoietic stem cell transplantation
Received autologous hematopoietic stem cell transplantation within 6 weeks
Cannot have received: experimental drug
Received other experimental drug treatments within the past 3 months
Lab requirements
Blood counts
ALC ≥ 0.5E9/L, PLT > 30E9/L, Hb > 80g/L
Kidney function
Creatinine clearance rate >30 mL/min
Liver function
ALT and AST ≤ 2.5 × ULN, which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin < 34 μMol/L
Cardiac function
Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%
The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin < 34 μMol/L; Creatinine clearance rate>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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