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

NCT06902025 | Not Yet Recruiting

• 1 other identifier: JY-CT-24-008
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

B-ALL

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events(AE) after infusion

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

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

• Maximal Tolerated Dose(MTD)

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

  Up to 28 days after infusion

Secondary Outcomes (1)

• Objective Response Rate

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

Study Arms (1)

A single-center, open, single arm study

EXPERIMENTAL

JY231 Injection for the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.

Drug: JY231 Injection

Interventions

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.

A single-center, open, single arm study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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.
• 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);
• 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;
• 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.

Sponsors & Collaborators

• He Huang: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Central Study Contacts

He Huang, PhD

CONTACT

0571-87236703; hehuangyu@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director of the Bone Marrow Transplantation Center

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)