Actively Recruiting
An Early-Phase Exploratory Study of JY231 Injection for Relapsed/Refractory B-Cell Lymphoma and Leukemia Evaluating Safety, Tolerability, and Preliminary Efficacy
Led by Shenzhen Genocury Biotech Co., Ltd. · Updated on 2025-05-15
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, in patients with relapsed or refractory B-cell lymphoma or leukemia. This early exploratory clinical study focuses on patients whose cancer has returned or is resistant to previous treatments, aiming to better understand how JY231 works in this population. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of chemotherapy with fludarabine and cyclophosphamide to prepare the body. Then, they will receive an intravenous infusion of the JY231 injection, which produces CAR-T cells in the body to target cancer cells. After infusion, patients will be hospitalized for one month for monitoring and then followed for up to two years to assess disease control and safety. During the study, patients will have regular safety checks and evaluations of their response to treatment at multiple time points up to 24 months. Researchers will monitor adverse events and determine the maximal tolerated dose within 28 days after infusion. The main outcome is safety, while treatment effectiveness will also be assessed through response rates within three months. Participants will be closely observed to understand how well the therapy controls their disease and to track any side effects over time.
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...
- Subjects must voluntarily sign informed consent and be able to follow all trial requirements
- Age between 18 and 75 years, any gender
- Presence of CD19-positive malignant cells in bone marrow or peripheral blood
- Diagnosis of relapsed or refractory B-cell lymphoma or leukemia including specified subtypes
- More than 5% primitive and naive lymphocytes in bone marrow
- No hematopoietic stem cell transplant within 6 months prior to enrollment
- At least one measurable lesion on imaging with specific size criteria and positive PET-CT
- Expected survival of more than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Adequate organ function with specified liver, kidney, heart, and oxygen levels
- Adequate bone marrow reserve without transfusion as defined by blood counts
- Discontinuation of certain drugs before infusion as specified
- Use of effective contraception during the study period by reproductive men and women
You will not qualify if you...
- Active malignant cells in cerebrospinal fluid, brain metastases, or active CNS lymphoma/leukemia
- History of active CNS disease such as seizures or autoimmune CNS involvement
- Use of other study drugs within 30 days before screening
- Previous anti-CD19 or anti-CD3 therapy except under specific conditions
- Prior gene therapy or CAR-T therapy except under specific conditions
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C infection, HIV, or treponema pallidum positive
- Uncontrolled severe infections within 72 hours before infusion
- Recent unstable heart conditions within 6 months
- Other malignancies except certain well-treated or fully remitted cancers
- Uncontrolled arrhythmias
- Oral anticoagulation use within 1 week before infusion
- Active neurological autoimmune or inflammatory diseases
- Pregnancy, breastfeeding, or planned pregnancy within 2 years after infusion
- Any medical condition or procedure posing unacceptable risk per investigator judgment
- Poor compliance or other investigator-determined exclusion factors
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 of lymphodepleting therapy plus 1 day for JY231 infusion
Participants receive lymphodepleting therapy for 3-5 days followed by an intravenous infusion of the JY231 CAR-T cell therapy.
1 hospitalization period of about 1 month for infusion and observation
Duration - Up to 24 months
Participants are monitored for safety and efficacy for up to 24 months after infusion to determine disease control.
Multiple visits including assessments at Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, and Month 24
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
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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