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JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia

ConditionB-ALL
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHe Huang

About this trial

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18~75 years old, gender is not limited;

Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);

Bone marrow cytomorphology with >5% prolymphocytes + juvenile lymphocytes; or flow Minimal Residual Disease(MRD) >=0.01%

Serum total bilirubin ≤ 51 mol/L, serum alanine aminotransferase (ALT) and azelaic transaminase (AST) both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L, and platelets ≥ 20×109/L;

Disqualifiers

Subjects with active central nervous system (CNS) leukemia;

Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;

Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;

Subjects who have had radiation therapy within 2 weeks prior to infusion;

Trial design

Design model

Single group

Treatments tested in this trial

  • JY231 Injection

    Drug

    Patients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 15 years.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: A single-center, open, single arm studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events(AE) after infusion

The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
2

Maximal Tolerated Dose(MTD)

MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

Time frame
Up to 28 days after infusion

Secondary outcomes

1

Objective Response Rate

Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).

Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: