Actively Recruiting
JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Led by Shenzhen Genocury Biotech Co., Ltd. · Updated on 2025-05-15
20
Participants Needed
1
Research Sites
143 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/Refractory B Cell Lymphoma/ Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers willing to sign informed consent and comply with trial requirements
- Age between 18 and 75 years, any gender
- Presence of CD19-positive malignant cells in bone marrow or blood
- Diagnosis of relapsed or refractory B-cell lymphoma or acute B-lymphocytic leukemia meeting specified clinical criteria
- Primitive and naive lymphocytes proportion in bone marrow greater than 5%
- No hematopoietic stem cell transplantation within 6 months before enrollment
- At least one measurable lesion by imaging with specified size and positive PET-CT
- Expected survival of more than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) score of 0-1
- Adequate organ function with specified liver, kidney, oxygen saturation, heart function parameters
- Adequate bone marrow reserve without transfusion, meeting specific blood count thresholds
- Required stopping of certain medications before infusion as specified
- Effective contraception used by reproductive men and fertile women throughout the study
You will not qualify if you...
- Active cerebrospinal fluid malignant cells, brain metastases, or active CNS lymphoma/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
- Previous anti-CD19 or anti-CD3 therapy, except in specific cases
- Previous gene therapy including CAR-T, except in specific cases
- Radiation therapy within 2 weeks prior to infusion
- Active hepatitis B or C infection, HIV positive, or positive for treponema pallidum
- Uncontrolled serious infections within 72 hours before infusion
- Unstable angina or recent myocardial infarction within 6 months
- Other malignancies except properly treated basal cell or squamous cell cancers and certain carcinoma in situ
- Uncontrolled arrhythmias
- Oral anticoagulation within 1 week before infusion
- Active neurological autoimmune or inflammatory diseases
- Pregnant or lactating women, or those planning pregnancy within 2 years after infusion
- Conditions or medical concerns that pose unacceptable risk as judged by investigators
- Poor compliance or other investigator-determined reasons preventing enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
X
Xinfeng Chen, PhD
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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