Actively Recruiting
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
Led by Tongji Hospital · Updated on 2025-07-08
20
Participants Needed
1
Research Sites
101 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 study requirements
- Age between 18 and 75 years regardless of gender
- Presence of CD19-positive malignant cells in bone marrow or peripheral blood
- Diagnosis of relapsed or refractory B-cell lymphoma or acute B-lymphocytic leukemia meeting specified clinical criteria
- Primitive and naive lymphocytes in bone marrow greater than 5%
- No hematopoietic stem cell transplantation within 6 months before enrollment
- At least one measurable lesion on imaging meeting size criteria and positive PET-CT
- Expected survival of more than 12 weeks
- ECOG performance status score of 0 to 1
- Adequate organ function including liver, kidney, lung oxygen saturation, heart function, and absence of significant pleural effusion
- Adequate bone marrow reserve without transfusion, meeting specified blood count levels
- Specific requirements regarding stopping steroids, immunosuppressive drugs, antiproliferative therapy, CD20 antibody therapy, and CNS disease prophylaxis before infusion
- Effective contraception use for reproductive men and fertile women throughout the study period
You will not qualify if you...
- Presence of active malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma/leukemia
- History of active CNS disease including seizures, cerebrovascular events, dementia, cerebellar disease, or autoimmune CNS involvement
- Receipt of other study drugs within 30 days before screening or ongoing washout period
- Prior anti-CD19 or anti-CD3 therapy or gene therapy including CAR-T unless specific conditions met
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C infection, HIV positive, or treponema pallidum positive
- Uncontrolled acute life-threatening infections
- Unstable angina or recent myocardial infarction within 6 months
- Concurrent or previous other malignancies except certain well-treated cancers in remission
- Uncontrolled arrhythmia
- Use of oral anticoagulants within 1 week before infusion
- Active neurological autoimmune or inflammatory conditions
- Pregnancy, lactation, or plans for pregnancy within 2 years post-infusion
- Medical conditions or procedures posing unacceptable risk per investigator judgment
- Poor compliance or other conditions deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hubei, China
Actively Recruiting
Research Team
J
Jia Wei, 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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