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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • CD19 CAR-T cells

    Drug

    Each subject receive CD19 CAR T-cells by intravenous infusion

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Administration of CD19 CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Complete remission rate after CD19 CAR-T cell therapy

Assessment of complete remission rate at 3 months after CD19 CAR-T cell therapy

Time frame
3 months after CD19 CAR-T cell therapy

Secondary outcomes

1

Overall response rate (ORR)

Assessment of ORR after ZR2 and CAR-T cell therapy

Time frame
After ZR2, 3 months after CAR-T cell therapy
2

Overall survival (OS)

From the start of treatment to death or the last visit

Time frame
Up to 2 years after CD19 CAR-T cells infusion
3

Progression-free survival (PFS)

From the start of the treatment to the occurrence of any event, including death, disease progression (any one occurs first), or the last visit

Time frame
Up to 2 years after CD19 CAR-T cells infusion
4

Duration of response (DOR)

among patients experiencing an objective response, defined as the time from the first objective response to events of disease progression or death from any cause

Time frame
Up to 2 years after CD19 CAR-T cells infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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