Actively Recruiting
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
Led by Shenzhen Genocury Biotech Co., Ltd. · Updated on 2024-11-07
20
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / 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 lymphoma / leukemia.
CONDITIONS
Official Title
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject voluntarily signs informed consent and can comply with all trial requirements
- Age is between 18 and 75 years old with no gender restriction
- Malignant cells in bone marrow or peripheral blood are CD19-positive as detected by flow cytometry
- Diagnosed with relapsed or refractory B-cell lymphoma or acute B-lymphocytic leukemia meeting specified clinical criteria
- Bone marrow examination shows more than 5% primitive and naive lymphocytes
- No hematopoietic stem cell transplantation within 6 months before enrollment
- At least one measurable lesion on imaging for relapsed or refractory B cell lymphoma with specified size criteria and positive PET-CT
- Expected survival period is more than 12 weeks
- Baseline ECOG score is 0-1
- Adequate organ function with specified limits for liver enzymes, bilirubin, creatinine, oxygen saturation, heart function, and no significant pleural effusion
- Adequate bone marrow reserve without transfusion, including ANC >1,000/mm3, ALC ≥300/mm3, platelets ≥50,000/mm3, hemoglobin >8.0 g/dl
- Specific medication restrictions before infusion including stopping steroids, immunosuppressants, antiproliferative therapy, CD20 antibody therapy, and CNS disease prophylaxis within defined timeframes
- Effective contraception use for reproductive men and fertile women throughout the study period
You will not qualify if you...
- Active malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma or leukemia
- History of active CNS disease such as seizures, stroke, dementia, cerebellar disease, or autoimmune CNS involvement
- Use of other study drugs within 30 days before screening or still in washout period
- Prior treatment with anti-CD19/CD3 therapy or other anti-CD19 therapies except in specific normal T cell conditions
- Previous gene therapy including CAR-T unless no CAR-T cells are present and normal T cell function exists
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C, HIV positive, or treponema pallidum positive
- Uncontrolled acute life-threatening infections
- Recent unstable angina or myocardial infarction within 6 months
- Concurrent or past malignancies except well-treated conditions or complete remission cases as specified
- Uncontrolled arrhythmias
- Oral anticoagulation within 1 week before infusion
- Active neurological autoimmune or inflammatory conditions
- Pregnancy, lactation, or planned pregnancy within 2 years after infusion
- Other medical conditions or study procedure contraindications judged unsafe by investigators
- Poor compliance or conditions affecting study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhenzhou, Henan, China, 450000
Actively Recruiting
Research Team
X
Xinfeng Chen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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