Actively Recruiting
JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Led by Affiliated Hospital of Guangdong Medical University · Updated on 2025-06-10
20
Participants Needed
1
Research Sites
130 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 who sign informed consent and can comply with trial requirements
- Aged 12 to 75 years, any gender
- Malignant cells in bone marrow or blood are CD19-positive by flow cytometry
- Diagnosed with relapsed or refractory B-cell lymphoma or acute B-lymphocytic leukemia meeting specified clinical criteria
- Bone marrow examination shows primitive and naive lymphocytes >5%
- No hematopoietic stem cell transplant within 6 months before enrollment
- At least one measurable lesion on imaging with specified size and positive PET-CT
- Expected survival of more than 12 weeks
- ECOG performance score of 0-1
- Adequate organ function with liver and kidney function limits specified
- Adequate bone marrow function without transfusions with specified blood counts
- Steroids stopped 72 hours before infusion except physiological doses
- Immunosuppressive drugs stopped at least 4 weeks before enrollment
- Other specified therapies stopped within defined timeframes before infusion
- Effective contraception used by reproductive men and fertile women during the study
You will not qualify if you...
- Active malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma/leukemia
- History of active CNS disease including seizures, stroke, dementia, or autoimmune CNS diseases
- Receipt of other study drugs within 30 days before screening or still in washout
- Prior anti-CD19/CD3 or other anti-CD19 therapies except under specific normal immune conditions
- Prior gene therapy including CAR-T unless no in vivo CAR-T cells and normal immune function
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C, HIV, or syphilis infection
- Uncontrolled acute severe infections within 72 hours before infusion
- Unstable angina or myocardial infarction within 6 months before screening
- Other malignancies except specified well-treated or remission conditions
- Uncontrolled arrhythmia
- Use of oral anticoagulants within 1 week before infusion
- Active neurological autoimmune or inflammatory conditions
- Pregnant or lactating women or planned pregnancy within 2 years after infusion
- Medical or investigator judgment of unacceptable risk or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jinqi Huang, PhD
CONTACT
J
Jinqi Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here