CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
ConditionLarge B-Cell Lymphoma (LBCL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CD19 CAR-T cells
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhejiang University
Lead sponsor
Yake Biotechnology Ltd.
Collaborator
Source ClinicalTrials.gov