JY231 injection for relapsed or refractory CD19-positive B-cell malignancies

JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy

This trial will test whether a single intravenous injection of JY231, an in vivo CAR-T therapy, can help adults with relapsed or refractory CD19-positive B-cell malignancies.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 2 Years to 75 Years
• Sex: All
• Sponsor: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China (other)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor
• Locations: 1 site (Kunming, Yunnan)
• Trial ID: NCT07065279 on ClinicalTrials.gov

What this trial studies

This open-label, single-arm, single-center study gives enrolled patients one intravenous infusion of JY231, an in vivo CAR-T preparation, and monitors them for safety, tolerability, and initial efficacy. Participants will remain hospitalized for approximately one month after infusion for close observation of acute reactions. Investigators will perform regular safety and disease assessments and follow subjects for up to two years to track disease control. The study targets adults with relapsed or refractory, CD19-positive B-cell malignancies and collects clinical and laboratory endpoints to characterize response and adverse events.

Who should consider this trial

Good fit: Adults up to 75 years old with histologically confirmed, relapsed or refractory CD19-positive B-cell malignancies who have ECOG ≤3, adequate organ function, and an expected survival of more than three months.

Not a fit: Patients whose tumors lack CD19 expression, who have severely impaired organ function or very limited life expectancy, or who cannot tolerate prolonged hospitalization are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, JY231 could provide a less complex in vivo CAR-T option that induces remissions in patients whose B-cell malignancies have relapsed or not responded to prior treatments.

How similar studies have performed: Autologous CD19-targeted CAR-T therapies have achieved high response rates in relapsed/refractory B-cell malignancies, but in vivo CAR-T approaches like JY231 are newer and have limited published clinical data.

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.

Where this trial is running

Kunming, Yunnan

• 920th HJointLogistics — Kunming, Yunnan, China (RECRUITING)

Study contacts

• Study coordinator: Sanbin Wang, PhD

Conditions: B-cell Malignancies, B cell tumor, CAR-T, in vivo