Actively Recruiting

Early Phase 1
Age: 0 - 75Years
All Genders
NCT06514768

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

Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2026-01-06

20

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Up to 75 years old, any gender
  • Bone marrow tests showing more than 5% primitive or immature lymphocytes, or MRD confirming B-ALL
  • Positive CD19 expression confirmed by flow cytometry or histology
  • Expected survival longer than 3 months as assessed by the researcher
  • Eastern Cooperative Oncology Group (ECOG) score 3 or less
  • Good liver, kidney, heart, and lung functions within specified limits
  • Peripheral blood counts meeting minimum levels: absolute lymphocyte count ≥0.5E9/L, platelet count >30E9/L, hemoglobin >80g/L
  • No active malignant cells in cerebrospinal fluid, no brain metastases or central nervous system leukemia as shown by MRI
  • Agreement to use effective contraception if fertile
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women, or planning pregnancy within 6 months
  • Positive for hepatitis B, hepatitis C, AIDS, syphilis, or cytomegalovirus
  • History of other tumors except certain cured skin or cervical cancers
  • Prior treatments targeting CD19
  • Autologous stem cell transplant within 6 weeks
  • Uncontrolled active bacterial or fungal infections
  • Allergies to study drugs or components
  • Active autoimmune diseases
  • Current unstable or active ulcers or gastrointestinal bleeding
  • Mental or psychological disorders preventing cooperation
  • Use of other experimental drugs within last 3 months
  • Grade II-IV acute graft-versus-host disease or widespread chronic GVHD
  • Any other reasons deemed unsuitable by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

920th HJointLogistics

Kunming, Yunnan, China

Actively Recruiting

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Research Team

S

Sanbin Wang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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