RecruitingPhase 2

CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

China40 participantsStarted 2020-12-03

Plain-language summary

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;

Complete remission rate after CD19 CAR-T cell therapy

Timeframe: 3 months after CD19 CAR-T cell therapy

NCT IDNCT04661020

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-20

He Huang, PhD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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;