Tests JY231 injection for relapsed or refractory B-cell acute lymphoblastic leukemia

Trial details

Who runs it

He Huang

Trial code

NCT06902025

Record updated

30 March 2025

Original description

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).Read full original descriptionShow less

An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)

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).

Inclusion: 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); Meet the diagnosis of relapsed/refractory (relapsed/refractory) r/r CD19+ B-ALL, including any of the following:; A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy; C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:; ① Relapse or refractory after treatment with at least two tyrosine kinase inhibitor (TKI) agents or intolerance to TKI-type agents; ② Resistance or failure to achieve remission after receiving second-line TKI therapy; ③ Not suitable for TKI therapy; 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; Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%; Subjects without active pulmonary infection and inspiratory finger pulse oxygen saturation ≥92%; Subjects have not received radiotherapy, chemotherapy, monotherapy or other anti-ALL therapy within 1 week prior to screening; Predicted survival of 3 months or more; Eastern Cooperative Oncology Group(ECOG) score of 0-2; Subjects or their legal guardians volunteered to participate in this study and signed an informed consent form.

Exclusion: 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; Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion); Subjects with unstable angina and/or myocardial infarction within 6 months prior to Screening; Subjects with other prior or concurrent malignancies, with the following exceptions:; ① Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study); ② Cancer in situ of the cervix or breast that has been curatively treated and shows no signs of recurrence for at least 3 years prior to study entry; ③ primary malignancy that has been completely resected and in complete remission for ≥ 5 years; Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement; Presence of subjects with arrhythmias not controlled by medical management; Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis); Subjects who, in the investigator's judgment and/or clinical criteria, have a contraindication to any of the investigational procedures or have other medical conditions that may place them at unacceptable risk; Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance; Subjects with active central nervous system (CNS) leukemia; Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion.

ClinicalTrials.gov NCT06902025