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OncoMatch/Clinical Trials/NCT06514768

JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)

Is NCT06514768 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies JY231 for b-cell acute lymphoblastic leukemia (b-all).

Early Phase 1Recruiting920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaNCT06514768Data as of Jun 2026Location: China

Treatment: JY231Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)

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Extracted eligibility criteria

Treatments studied

Other

JY231

Cancer type

Acute Lymphoblastic Leukemia

Biomarker criteria

Required: CD19 positive expression

Performance status

ECOG 0–3(Limited self-care)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06514768 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior CD19-targeted therapy, autologous hematopoietic stem cell transplantation, experimental drug disqualifies patients from enrollment.

Does this trial require CD19?

Yes, CD19 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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