Actively Recruiting
JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
Led by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China · Updated on 2025-07-15
36
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Malignancies.
CONDITIONS
Official Title
JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age up to 75 years, any sex, and able to provide informed consent
- Histologically confirmed B-cell Malignancies
- Positive expression of CD19 confirmed by flow cytometry or histology
- Expected survival period longer than 3 months as assessed by the researcher
- Eastern Cooperative Oncology Group (ECOG) score of 3 or less
- Good liver, kidney, heart, and lung functions: ALT and AST ≤ 2.5 times upper limit of normal (ULN), or ≤ 5 times ULN if liver is invaded; total serum bilirubin ≤ 34 μMol/L; creatinine clearance > 30 mL/min; cardiac ejection fraction ≥ 40% without pericardial effusion or significant arrhythmia; oxygen saturation ≥ 92%
- Peripheral blood lymphocyte count ≥ 0.5 × 10^9/L, platelet count > 30 × 10^9/L, hemoglobin > 80 g/L; single venous access and no contraindications for blood cell separation
- Individuals with fertility agree to use effective contraceptive methods
- Subject or legal guardian able to understand and voluntarily sign informed consent form
You will not qualify if you...
- Pregnant or lactating women, or women planning pregnancy within six months
- Positive virological tests for hepatitis B, hepatitis C, AIDS, syphilis, or cytomegalovirus
- History of other tumors except treated skin or cervical carcinoma in situ without active disease
- Previous treatment targeting CD19
- Autologous hematopoietic stem cell transplantation within 6 weeks prior to study
- Uncontrollable active bacterial or fungal infections
- Allergies to study drugs or cellular components
- Presence of active autoimmune diseases
- Current unstable or active ulcers or gastrointestinal bleeding
- Mental or psychological disorders preventing cooperation with treatment or evaluation
- Receipt of other experimental drugs within the past 3 months
- Grade II-IV acute graft versus-host disease or widespread chronic graft versus-host disease
- Any other reasons judged by researchers as unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
920th HJointLogistics
Kunming, Yunnan, China
Actively Recruiting
Research Team
S
Sanbin Wang, PhD
CONTACT
M
Mengli Xu
CONTACT
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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