A Clinical Study of Humanized CD19 CAR-T Cells With TLR2 for the Treatment of Adult Patients With Naive B-Cell Acute Lymphoblastic Leukemia/Lymphoma Who Are Intolerant to Intensive Chemotherapy

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhujiang Hospital

About this trial

The purpose of this clinical trial is to tolerability and safety of humanized CD19 CAR-T therapy with TLR2 in adult patients with acute B lymphoblastic leukemia/lymphoma who cannot tolerate intense chemotherapy at initial treatment. Participants will receive a single infusion of CD19 CAR-T and complete follow-ups over the next three years.

Eligibility criteria

Qualifiers

Newly treated patients with acute B-lymphocytic leukaemia/lymphoma who are clinically determined to be unable to tolerate strong chemotherapy;

age 18-80 years old (including boundary value), both men and women can;

The physical status of the American Eastern Cancer Collaboration Group (ECOG) was 0~2 points;

Positive CD19 confirmed by flow cytometry and/or histopathology;

Disqualifiers

severe cardiac insufficiency, left ventricular ejection fraction <50%;

have a history of severe lung function impairment;

Combined with other advanced malignant tumors;

Had severe infection within 4 weeks before enrollment and could not be effectively controlled;

Trial design

Treatments tested in this trial

  • humanized CD19 CAR-T Cells with TLR2

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators