Clinical trial NCT06514768: JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)
Official title: JY231 Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL ) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: B-cell Acute Lymphoblastic Leukemia( B-ALL )
Lead sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 20
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 )


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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: At 2,4,8 and 12 weeks after infusion
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 24 weeks after infusion
measure: Overall survival (OS)
timeFrame: Up to 24 weeks after infusion
measure: Duration of remission (DOR)
timeFrame: Up to 24 weeks after infusion
measure: Incidence of Treatment Related adverse events (AEs)
timeFrame: Up to 12 months after infusion
Other outcomes:
Locations:
city: Kunming
country: China
facility: 920th HJointLogistics
state: Yunnan
Study officials:
affiliation: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
name: Sanbin Wang
role: PRINCIPAL_INVESTIGATOR
References: