A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies

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Zhejiang University

Status and phase

Early Phase 1


Non-Hodgkin Lymphoma of Soft Tissue
Acute Lymphoblastic Leukemia


Drug: Murine CD19 CAR-T cells

Study type


Funder types




Details and patient eligibility


A Study of Murine CD19 CAR-T Cells Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies.

Full description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. Two groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose- related safety.


120 estimated patients




No Healthy Volunteers

Inclusion criteria

Inclusion criteria only for B-ALL:

Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);

Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):

  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
  • Ineffectively after first or multiple remedial treatments;
  • 2 or more relapses;
  • The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is > 5% (by morphology), and/or > 1% (by flow cytometry);
  • Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;

Inclusion criteria only for B-NHL:

Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);

Relapsed or refractory B-NHL (meeting one of the following conditions):

  • No response or relapse after second-line or above chemotherapy regimens;
  • Primary drug resistance;
  • Relapse after auto-HSCT;
  • At least one assessable tumor lesion per Lugano 2014 criteria;

Common inclusion criteria for B-ALL and B-NHL:

  • 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;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Subjects with any of the following exclusion criteria were not eligible for this trial:

  • 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;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tractinfectionand bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
  • Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  • Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

120 participants in 1 patient group

Administration of Murine CD19 CAR T-cells
Experimental group
Drug: Murine CD19 CAR-T cells

Trial contacts and locations



Central trial contact

He Huang, PhD; Yongxian Hu, PhD

Data sourced from clinicaltrials.gov

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