To hear about similar clinical trials, please enter your email below
Trial Title:
JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)
NCT ID:
NCT06514768
Condition:
B-cell Acute Lymphoblastic Leukemia( B-ALL )
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
JY231
Description:
Infusion of JY231 Injection by dose of 1-10×10^6 Transduction Units(TU)/ kg、1-5×10^7
TU/kg、5-10 ×10^7 TU/kg. Administration method: intravenous infusion、Splenic artery
infusion、Lymph node infusion; Subjects will be treated with Fludarabine and
Cyclophosphamide before cell infusion (PI evaluation is required)
Arm group label:
JY231 injection for the treatment of B-cell acute lymphoblastic leukemia( B-ALL )
Summary:
Early exploratory clinical study of the safety, tolerability and initial efficacy of
JY231 injection in the treatment of B-cell acute lymphoblastic leukemia( B-ALL )
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. up to 75 years (Child, Adult) , either sex, sign informed consent (ICE)；
2. Histologically confirmed as B cell ALL ;
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. MRI examination showed no central involvement of lymphoma; No central nervous system
leukemia;
9. Individuals with fertility must agree to the use of efficient contraceptive methods;
10. 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.
Gender:
All
Minimum age:
N/A
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
920th HJointLogistics
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Start date:
June 20, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Agency class:
Other
Source:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06514768
