Actively Recruiting
An Early Exploratory Study of JY231 Injection for Relapsed or Refractory B-Cell Lymphoma and Leukemia Evaluating Safety, Tolerability, and Preliminary Efficacy
Led by Affiliated Hospital of Guangdong Medical University · Updated on 2025-06-10
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, an in vivo CAR-T cell therapy, for patients with relapsed or refractory B cell lymphoma or leukemia. This early exploratory, open-label, single-arm clinical study targets individuals aged 12 to 75 years who have specific types of B-cell malignancies that have not responded to prior treatments. The goal is to better understand how this therapy affects the disease and patient safety. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of lymphodepleting chemotherapy with fludarabine and cyclophosphamide. After this preparation, they will receive an intravenous infusion of JY231, which produces CAR-T cells directly in the body. Following infusion, patients will be hospitalized for one month for close observation and monitoring. Throughout the study, participants will be closely monitored for adverse events and treatment tolerance up to two years. Safety assessments and disease control will be evaluated at multiple time points, including days 28, months 2, 3, 6, 12, 18, and 24. Researchers will also measure the maximal tolerated dose and objective response rate within three months post-infusion. This comprehensive follow-up ensures a detailed understanding of therapy effects and patient well-being.
CONDITIONS
Brief Title
JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent and agree to comply with trial requirements
- Age between 12 and 75 years, any gender
- Malignant cells must be CD19-positive by flow cytometry
- Diagnosed with relapsed or refractory B-cell lymphoma including iNHL, FL, MZL, DLBCL, PMBCL, TFL, TCRBCL, or acute B-lymphocytic leukemia meeting specified relapse/refractory conditions
- Primitive and naive lymphocytes in bone marrow > 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 longer than 12 weeks
- Baseline ECOG score 0-1
- Adequate organ functions within defined limits
- Adequate bone marrow reserve without transfusion
- Certain medications stopped within specified timeframes before infusion
- Use of effective contraception by 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/leukemia
- History of active CNS disease including seizures, stroke, dementia, or autoimmune CNS involvement
- Received other study drugs within 30 days before screening
- Prior anti-CD19 or anti-CD3 therapy unless specific normal T cell conditions met
- Previous gene therapy including CAR-T unless specific conditions met
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C, HIV, or syphilis infection
- Uncontrolled serious infections
- Recent unstable angina or myocardial infarction
- Other malignancies except well-treated or in remission under specified conditions
- Uncontrolled arrhythmias
- Use of oral anticoagulants within 1 week before infusion
- Active neurological autoimmune or inflammatory diseases
- Pregnant or lactating women or those planning pregnancy within 2 years post-infusion
- Medical conditions or procedures increasing risk as judged by investigator
- Poor compliance or other conditions unsuitable for study participation
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo leukapheresis followed by 3 to 5 days of lymphodepleting therapy with fludarabine and cyclophosphamide before receiving the study drug.
Multiple visits over 1 week
Duration - Single day infusion
Participants receive an intravenous infusion of JY231 injection to produce CAR-T cells in the body.
1 infusion visit (in-person)
Duration - Up to 24 months
Participants are hospitalized for one month for observation after infusion and then followed for up to 24 months to evaluate safety and efficacy of the treatment.
Hospitalization for 1 month followed by scheduled visits up to 24 months
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Guangdong Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jinqi Huang, PhD
J
Jinqi Huang
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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