Recruiting
Not applicable
JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
Condition(s) studied
B-cell Malignancies
Investigational drug(s) / intervention(s)
JY231 Injection: Patients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.
Study summary
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.
Eligibility
Inclusion Criteria:
1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
2. Histologically confirmed as B-cell Malignancies ;
3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);
4. According to the researcher's assessment, the expected survival period is greater than 3 months;
5. Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin # 34 μ Mol/L; Creatinine clearance rate\>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;
7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)\>30 × 109/L, Hb\>80 g/L, with a single venous access and no other contraindications for blood cell separation;
8. Individuals with fertility must agree to the use of efficient contraceptive methods;
9. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Pregnant or lactating women, as well as women with pregnancy plans within six months;
2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
4. Previously received treatment targeting CD19;
5. Received autologous hematopoietic stem cell transplantation within 6 weeks;
6. The presence of uncontrollable active bacterial or fungal infections;
7. Allergies to research related drugs or cellular components;
8. Active autoimmune diseases exist;
9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
11. Received other experimental drug treatments within the past 3 months;
12. Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;
13. Researchers believe that other reasons are not suitable for clinical trial participants.
Primary outcome measure(s)
- Maximal Tolerated Dose(MTD) — Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
- Incidence of adverse events(AE) after infusion — Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Trial sites (1)
| Facility | City | Region | Status |
| 920th HJointLogistics |
Kunming |
Yunnan |
Recruiting |
More 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China trials in China
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