A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL

  • STATUS
    Recruiting
  • End date
    Aug 23, 2026
  • participants needed
    72
  • sponsor
    Zhejiang University
Updated on 25 January 2021

Summary

A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.

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 numberof 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.

Details
Condition childhood ALL, Lymphocytic Leukemia, Acute, Lymphocytic Leukemia, Acute, Non-hodgkin Lymphoma,B Cell, Non-hodgkin Lymphoma,B Cell, acute lymphoblastic leukemia, leukemia, acute lymphoblastic, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), Non-hodgkin Lymphoma,B Cell
Treatment Humanized CD19 CAR-T cells
Clinical Study IdentifierNCT04532268
SponsorZhejiang University
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion criteria only for B-ALL
Male or female aged 3-70 years
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
Male or female aged 18-75 years
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 tract infection and 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 inhaled 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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