Actively Recruiting
Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2026-01-06
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 treating B-cell acute lymphoblastic leukemia (B-ALL). This early phase 1 clinical study aims to understand how well patients with B-ALL can tolerate the treatment and to observe any early signs of benefit. The research is sponsored by the 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China. Participants receive JY231 injection through intravenous infusion, splenic artery infusion, or lymph node infusion at doses ranging from 1 to 10 x 10^6, 1 to 5 x 10^7, or 5 to 10 x 10^7 Transduction Units (TU) per kilogram. Before receiving the cell infusion, patients are treated with Fludarabine and Cyclophosphamide, with prior investigator evaluation required. The study measures responses and monitors adverse events over various time points up to two years after infusion. During the study, participants are monitored for treatment-related adverse events for up to 12 months and for maximum tolerated dose within 28 days after infusion. Effectiveness is assessed by overall response rates at 2, 4, 8, and 12 weeks, as well as the best overall response up to 24 weeks. Duration of remission, time to progression, progression-free survival, and overall survival are evaluated for up to two years. Participants undergo regular assessments including physical exams, laboratory tests, and imaging to track safety and treatment impact throughout the study period.
CONDITIONS
Brief Title
JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Up to 75 years old, any sex
- Bone marrow examination shows more than 5% primitive and immature lymphocytes or MRD confirms B-ALL
- Positive CD19 expression confirmed by flow cytometry or histology
- Expected survival longer than 3 months as assessed by researcher
- ECOG physical condition score of 3 or less
- Good liver, kidney, heart, and lung functions within specified limits
- Peripheral blood counts meet minimum levels and no contraindications for blood cell separation
- MRI shows no active malignant cells in cerebrospinal fluid, no brain metastases, or no central nervous system leukemia
- Agree to use effective contraception if fertile
- Able to understand and sign informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women, or planning pregnancy within six months
- Positive tests for hepatitis B, hepatitis C, AIDS, syphilis, or cytomegalovirus
- History of other tumors except certain cured skin or cervical cancers
- Prior treatment targeting CD19
- Autologous stem cell transplant within past 6 weeks
- Uncontrolled active bacterial or fungal infections
- Allergies to study drugs or cell components
- Active autoimmune diseases
- Current unstable or active ulcers or gastrointestinal bleeding
- Mental disorders preventing cooperation with treatment and evaluation
- Received other experimental drug treatments within past 3 months
- Presence of grade II-IV acute graft versus-host disease or widespread chronic GVHD
- Any other reason deemed unsuitable by researchers
AI-Screening
AI-Powered 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 - Up to 28 days after infusion
Participants receive JY231 injection via intravenous, splenic artery, or lymph node infusion after pre-treatment with Fludarabine and Cyclophosphamide.
1 infusion visit and multiple follow-up visits up to 12 months
Duration - Up to 2 years after infusion
Participants are monitored for safety, response to treatment, and survival outcomes for up to 2 years after infusion.
Visits at 2, 4, 8, and 12 weeks, and additional visits up to 2 years
Trial Site Locations
Total: 1 location
1
920th HJointLogistics
Kunming, Yunnan, China
Actively Recruiting
Research Team
S
Sanbin Wang, 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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