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New treatment option for Large B-Cell Lymphoma (LBCL)
Official title CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT04661020
What this study is testing
What is CD19 CAR-T cells?
CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma (lbcl).
Also referred to as CD19 CAR-T cells injection.
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
- A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age no less than 18, no gender limit;
- Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3...
- Confirmed CD19 and CD20 postive expressions in lymphoma cells
- ECOG score 0-2;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
You likely can't join if
- Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and...
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ;
See the full eligibility criteria
- Age no less than 18, no gender limit;
- Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene...
- Confirmed CD19 and CD20 postive expressions in lymphoma cells
- ECOG score 0-2;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
- Estimated survival time ≥ 3 months;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
- Central nervous system involvement by lymphoma；History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.