Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory CD19-positive Lymphoma.

  • STATUS
    Recruiting
  • End date
    Oct 23, 2023
  • participants needed
    18
  • sponsor
    Hrain Biotechnology Co., Ltd.
Updated on 23 January 2021
fludarabine
cyclophosphamide
hodgkin's disease
ejection fraction
cell transplantation
neutrophil count
follicular lymphoma
cancer chemotherapy
diffuse large b-cell lymphoma
b-cell lymphoma
large b-cell lymphoma

Summary

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Description

Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.

Details
Condition Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, CD19 Positive, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment Human CD19 targeted T Cells Injection
Clinical Study IdentifierNCT03720457
SponsorHrain Biotechnology Co., Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have any of these conditions: CD19 Positive or Lymphoma or Diffuse Large B-Cell Lymphoma or Non-Hodgkin's Lymphoma or Follicular Lymphoma?
Do you have any of these conditions: CD19 Positive or Diffuse Large B-Cell Lymphoma or diffuse large cell lymphoma or diffuse large b cell lymphoma or Lymphoma or Non-Hodgkin's Lymphoma o...?
Male or female subjects with CD19+ B cell lymphomas who have a limited
prognosis (several months to <2 year survival) with currently available
therapies will be enrolled
18 to 70 Years Old, Male and female
Expected survival > 12 weeks
Clinical performance status of ECOG score 0-1
Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions
Relapsed and refractory CD19-positive Diffuse large B-cell lymphoma and Follicular lymphoma: patients previously received at least first-line and secondline treatment and fail to achieve CR
Disease recurrence after stem cell transplantation, and at least 1 years after stem cell transplantation
It can establish the venous access required for collection, satisfying hemoglobin 70 g / L, neutrophils 1.0 10 ^ 9 / L, platelets 50 10 ^ 9 / L. Mononuclear cell collection can be determined by the investigators
At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria
Liver, kidney and cardiopulmonary functions meet the following requirements
Serum creatinine 1.5 ULN
Left ventricular ejection fraction >50%, no pericardial effusion and no pleural effusion (ECHO examination)
Baseline oxygen saturation > 92%
Total bilirubin 1.5 ULN
ALT and AST 3 ULN
Able to understand and sign the Informed Consent Document

Exclusion Criteria

In the first 5 years before screening, there are malignant tumors other than diffuse large B-cell lymphoma and follicular lymphoma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgeryand catheter carcinoma in situ after radical surgery
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency Viral (HIV) antibody positive; Positive syphilis test
Any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification III), severe arrhythmia , liver, kidney or metabolic disease requiring medication
Any other diseases could affect the outcome of this trial
Any affairs could affect the safety of the subjects or outcome of this trial
Pregnant or lactating women, or planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion
Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment
Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion
Received CAR-T treatment or other gene therapies before enrollment
Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment
Subject suffering disease affects the understanding of informed consent or comply with study protocol
The investigators consider other conditions unsuitable for enrollment
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