Status:
NOT_YET_RECRUITING
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia
Lead Sponsor:
He Huang
Conditions:
B-ALL
Eligibility:
All Genders
18-75 years
Phase:
NA
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 s...
Detailed Description
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory B-cell Acute Lymphoblas...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06902025
Start Date
March 31 2025
End Date
December 31 2027
Last Update
March 30 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003