CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Recruiting now · Phase 2
Conditions studied: Large B-Cell Lymphoma (LBCL)
In brief
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Key facts
- Study ID
- NCT04661020
- Run by
- Zhejiang University
- People needed
- 40
- Starts
- 2020-12-03
- Expected to finish
- 2026-12-20
- Last updated by the study team
- 2026-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified;
- 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.
You may not qualify if…
- 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.
Where it is running
- The First Affiliated Hospital，College of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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