Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The First Affiliated Hospital with Nanjing Medical University
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥18 years, male and female,
Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry
No effective treatment
Patients must have a measurable or evaluable disease at the time of enrollment.
Adequate organ system function including:
* ALT/AST \< 3 upper limit of normal; Total Bilirubin \< 2.5 upper limit of normal
* Creatinine \< 2 upper limit of normal
* Oxygen saturation ≥ 95%
* Left ventricular ejection fraction ≥ 40%
* Number of neutrophil ≥ 0.75×10\^9/L, number of platelet ≥ 50×10\^9/L
At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments)
No contraindications of peripheral blood apheresis
Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures
ECOG score 0-2, expected survival ≥ 12 weeks
You may not be if
Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons
Subjects with any autoimmune disease or any immune deficiency disease
Have a history of allergy to antibodies or cellular products
Participated in any other clinical trial within four weeks
Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions)
Have mental diseases
Have history of drug addiction
The investigators believe that any increase in the risk of the subject or interference with the results of the trial
Clareo Health | XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
