Actively Recruiting
JY231 Injection for Relapsed or Refractory B-cell Lymphoma and Leukemia: An Early Exploratory Study of Safety, Tolerability, and Initial Efficacy
Led by Tongji Hospital · Updated on 2025-07-08
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and initial effectiveness of JY231 injection in patients with relapsed or refractory B-cell lymphoma or leukemia. This early exploratory clinical study focuses on people whose cancer has returned or not responded to previous treatments. The study is designed to explore an in vivo CAR-T cell therapy approach for these conditions. The study includes two pretreatment options: lymphodepletion and non-lymphodepletion regimens. In the lymphodepletion regimen, patients undergo leukapheresis followed by 3 to 5 days of chemotherapy with fludarabine and cyclophosphamide, then receive an intravenous infusion of JY231 and their own peripheral blood mononuclear cells (PBMCs). In the non-lymphodepletion regimen, patients receive a direct intravenous injection of JY231. After treatment, patients are monitored for safety and efficacy up to three months, with a follow-up of at least 24 months for those who achieve sustained remission. Participants will receive intravenous JY231 infusion, which produces CAR-T cells inside the body. Throughout the study, safety and response to treatment will be assessed at multiple time points up to 24 months, including checking for adverse events and the maximum tolerated dose. Researchers will use imaging, blood tests, and clinical evaluations to monitor disease control and organ function. Participants are expected to have good organ function and meet specific health criteria before joining, and they will be followed closely during and after treatment to assess outcomes and safety.
CONDITIONS
Brief 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...
- Ages 18 to 75 years, any gender
- Voluntarily signed informed consent and able to follow trial requirements
- CD19-positive malignant cells in bone marrow or blood
- Diagnosed with relapsed or refractory B-cell lymphoma or acute B-lymphocytic leukemia meeting specific clinical criteria
- Bone marrow primitive and naive lymphocytes > 5%
- No hematopoietic stem cell transplant within 6 months before enrollment
- At least one measurable lesion with specified size and positive PET-CT
- Expected survival period longer than 12 weeks
- ECOG performance score of 0-1
- Adequate organ function with specified limits for liver, kidney, heart, and oxygen saturation
- Adequate bone marrow reserve without transfusion
- Certain medications stopped before infusion as specified
- Agreed to use effective contraception 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 or autoimmune CNS involvement
- Received other study drugs within 30 days before screening or during washout
- Prior anti-CD19/CD3 therapies or gene therapy including CAR-T unless specified
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B, hepatitis C, HIV, or syphilis infection
- Uncontrolled acute infections within 72 hours before infusion
- Recent unstable angina or myocardial infarction within 6 months
- Other malignancies except certain treated cancers without recurrence
- Uncontrolled arrhythmias
- Oral anticoagulation within 1 week before infusion
- Active neurological autoimmune or inflammatory diseases
- Pregnant or lactating females or planned pregnancy within 2 years after infusion
- Medical conditions or procedures that pose unacceptable risk or poor compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 5 days for lymphodepletion plus infusion or immediate infusion for non-lymphodepletion
Participants receive the JY231 injection. Depending on the regimen, this includes leukapheresis and 3-5 days of lymphodepleting therapy followed by infusion, or direct intravenous injection of JY231.
1 baseline visit and subsequent infusion visit(s)
Duration - Up to 3 months
Participants undergo safety and efficacy assessments for up to 3 months after infusion to monitor response and adverse events.
Visits at Day 28, Month 2, and Month 3 post-infusion
Duration - At least 24 months
Participants who achieve sustained remission at 3 months post-infusion are followed for at least 24 months to evaluate disease control status and long-term safety.
Visits at Months 6, 12, 18, and 24 post-infusion
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
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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