JY231(JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia(B-ALL)

Early Phase 1

Recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia( B-ALL )
• Interventions: Biological: JY231

• Registration Number: NCT06514768
• Lead Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

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 )

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JY231 injection for the treatment of B-cell acute lymphoblastic leukemia( B-ALL )	JY231	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	At 2,4,8 and 12 weeks after infusion	Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 24 weeks after infusion	Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause.
Overall survival (OS)	Up to 24 weeks after infusion	Overall survival (OS) is the time from randomization to death from any cause.
Incidence of Treatment Related adverse events (AEs)	Up to 12 months after infusion	The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Duration of remission (DOR)	Up to 24 weeks after infusion	Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD.

Trial Locations

Locations (1)

920th HJointLogistics; 🇨🇳 Kunming, Yunnan, China