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New treatment option for B-cell Malignancies
Official title JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
ClinicalTrials.gov ID: NCT07065279
What this study is testing
What is JY231 Injection?
JY231 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell malignancies.
Also referred to as in vivo CAR-T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 75
You may be able to join 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;
You likely can't join 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;
See the full eligibility criteria
- 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...
- 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.
- 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 how well it works 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kunming, Yunnan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.