JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies

NCT ID: NCT07065279

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-12-31

Brief 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.

Detailed Description

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory B-cell Malignancies. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.

Conditions

B-cell Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JY231 injection for the treatment of r/r B-cell Malignancies Early exploratory clinicaltrial

A single-center, open, single arm study JY231 Injection for the treatment of relapsed or refractory B-cell Malignancies subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject.

Group Type: EXPERIMENTAL

JY231 Injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

in vivo CAR-T

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

920th HJointLogistics

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sanbin Wang, PhD

Role: CONTACT

sanbin1011@163.com

+86 13187424131

Mengli Xu

Role: CONTACT

menglixu0318@163.com

+86 18771696856

Facility Contacts

Sanbin Wang, PhD,MD

Role: primary

sanbin1011@163.com

+8613187424131

Other Identifiers

JY-CT-25-008

Identifier Type: -

Identifier Source: org_study_id