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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 920th HJointLogistics
  Kunming, Yunnan, China Recruiting

Study contacts

• Study coordinator: Sanbin Wang, PhD
• Email: sanbin1011@163.com
• Phone: +86 13187424131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.