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

NCT07065279 | Recruiting

• 1 other identifier: JY-CT-25-008
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Malignancies

Keywords

B cell tumor; CAR-T; in vivo

Outcome Measures

Primary Outcomes (2)

• Maximal Tolerated Dose(MTD)

  MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

Secondary Outcomes (1)

• Objective Response Rate

  Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: JY231 Injection

Interventions

JY231 Injection 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.

Also known as: in vivo CAR-T

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

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
• Histologically confirmed as B-cell Malignancies ;
• Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);
• According to the researcher's assessment, the expected survival period is greater than 3 months;
• Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
• 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%;
• 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;
• Individuals with fertility must agree to the use of efficient contraceptive methods;
• The subject or their legal guardian can understand and voluntarily sign a written informed consent form.

You may not qualify if:

• Pregnant or lactating women, as well as women with pregnancy plans within six months;
• Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
• Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
• Previously received treatment targeting CD19;
• Received autologous hematopoietic stem cell transplantation within 6 weeks;
• The presence of uncontrollable active bacterial or fungal infections;
• Allergies to research related drugs or cellular components;
• Active autoimmune diseases exist;
• Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
• Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
• Received other experimental drug treatments within the past 3 months;
• Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;
• Researchers believe that other reasons are not suitable for clinical trial participants.

Sponsors & Collaborators

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

Study Sites (1)

920th HJointLogistics

Kunming, Yunnan, China

RECRUITING

Central Study Contacts

Sanbin Wang, PhD

CONTACT

+86 13187424131; sanbin1011@163.com

Mengli Xu

CONTACT

+86 18771696856; menglixu0318@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 15, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)