CD19-CAR-T in B-cell Malignancies Patients

  • End date
    Oct 31, 2021
  • participants needed
  • sponsor
    Hebei Yanda Ludaopei Hospital
Updated on 24 January 2021


This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.


This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-CAR-T cells. Safety and efficacy of CD19-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19-CAR-T cells therapy in patients with refractory and relapsed B-cell malignancies.

Condition B Cell Malignancy
Treatment CD19-CAR-T Cells
Clinical Study IdentifierNCT03952923
SponsorHebei Yanda Ludaopei Hospital
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

Relapsed and refractory CD19 positive B-cell acute malignancies with
Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD0.1%)
MRD0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD 0.1% after HSCT
Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD 0.1%
Patients must have evaluable evidence of disease, including minimal residual disease (MRD)
Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant
Ages 1 to 70 years, including boundary values
ECOG score 0-3 points
Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside

Exclusion Criteria

patients with organ failure
Heart: NYHA heart function grade IV
Liver: Grade C that achieves Child-Turcotte liver function grading
Kidney: kidney failure and uremia
Lung: symptoms of respiratory failure
Brain: a person with a disability
Active infections that are difficult to control
Human immunodeficiency virus (HIV) positive
Liver and kidney function: total bilirubin > 5 ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 5 ULN, serum creatinine clearance rate 60mL / min
GVHD 2 or anti-GVHD treatment
Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion
Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week
Central nervous system white blood that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count >15WBCs/mL)
intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation
pregnant or lactating women
The patient does not agree to use effective contraception during the treatment period and for the next 3 months
Patients who participate in other clinical studies at the same time
The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study
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