Actively Recruiting
JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia - A Safety, Tolerability, and Efficacy Study
Led by Shenzhen Genocury Biotech Co., Ltd. · Updated on 2024-11-07
20
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and initial effectiveness of JY231 injection in patients with relapsed or refractory B cell lymphoma or leukemia. This early exploratory clinical trial focuses on patients whose cancer has returned or not responded to previous treatments, aiming to evaluate a new in vivo CAR-T cell therapy approach. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of lymphodepleting chemotherapy with fludarabine and cyclophosphamide. Then, they will receive an intravenous infusion of JY231, which is designed to produce CAR-T cells inside the body. The study starts with a set starting dose and may escalate to higher doses to assess safety. During the study, participants will be monitored for safety and treatment response for up to 24 months. Researchers will track adverse events at multiple time points and evaluate the maximum tolerated dose within 28 days after infusion. They will also measure the objective response rate up to 3 months after treatment. Participants will undergo regular assessments, including imaging and laboratory tests, to determine disease control and overall health throughout the study period.
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...
- Participants 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 acute B-lymphocytic leukemia meeting specified clinical criteria
- More than 5% primitive and naive lymphocytes in bone marrow cells
- No hematopoietic stem cell transplantation within 6 months before enrollment
- At least one measurable lesion by imaging with specific size criteria and positive PET-CT
- Expected survival of more than 12 weeks
- Baseline ECOG score of 0 or 1
- Adequate organ function including liver, kidney, oxygen saturation, and heart function
- Adequate bone marrow reserve without transfusion, with specified blood counts
- Use of steroids and immunosuppressive drugs stopped as required before infusion
- Effective contraception for reproductive men and fertile women during the study period
You will not qualify if you...
- Active CNS malignant cells, brain metastases, CNS lymphoma, or CNS leukemia
- History of active CNS disease including seizures or autoimmune diseases affecting CNS
- Use of other study drugs within 30 days before screening
- Prior treatment with anti-CD19 or anti-CD3 therapies, or gene therapy including CAR-T, except under specific conditions
- Radiation therapy within 2 weeks before infusion
- Active hepatitis B or C, HIV, or syphilis infection
- Uncontrolled acute infections
- Recent unstable angina or myocardial infarction within 6 months
- Current or prior other malignancies except certain treated cancers without recurrence
- Uncontrolled arrhythmia
- Oral anticoagulation within 1 week before infusion
- Active neurological autoimmune or inflammatory conditions
- Pregnancy, lactation, or planned pregnancy within 2 years after infusion
- Medical conditions or procedures putting participant at unacceptable risk as judged by investigator
- Poor compliance or other conditions preventing participation
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.
Duration - Up to 28 days after infusion
Participants receive lymphodepleting chemotherapy for 3 to 5 days followed by an intravenous infusion of the JY231 CAR-T cell therapy.
1 baseline visit and multiple visits during treatment period
Duration - Up to 24 months
Participants are monitored for safety and efficacy for up to 24 months after infusion to determine disease control and adverse events.
Visits on 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
Zhenzhou, Henan, China, 450000
Actively Recruiting
Research Team
X
Xinfeng Chen, 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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