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Clinical Trial for the Efficacy and Safety of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

Who is this study for? Elderly patients with B-cell non-Hodgkin's lymphoma
What treatments are being studied? CD19 CAR-T cells
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital,College of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, PhD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, PhD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2020-12-03
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 40
Treatments
Experimental: Administration of CD19 CAR T-cells
Related Therapeutic Areas
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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