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
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
Treatments tested in this trial
- JY231 Injection
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
He Huang
Lead sponsor
Zhejiang University
Sponsor institution
Source ClinicalTrials.gov