Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
CD19/CD20-directed Chimeric Antigen Receptor T Cells
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient volunteered to participate in the study and signed the Informed Consent;
Age, 18-70 years (include 18 and 70), male or female;
Expected survival ≥ 12 weeks
Eastern Cooperative Oncology Group score 0-2
CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histologyaccording to World Health Organization 2016 criteria;
Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin'slymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and MantleCell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
Diffuse Large B Cell Lymphoma, Non Specifically
Primary Mediastinal B-cell Lymphoma
Transformed Follicular Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
High Grade B-Cell Lymphoma, Non Specifically
For CD20-positive subjects, they should have received at least one regimencontaining anti-CD20-targeted therapy (such as rituximab). If they do not completethe regimen due to intolerance, the cause of intolerance should be recorded;
No contraindications of apheresis.
At least one measurable lesion according to Lugano 2014 criteria;
Adequate organ function and adequate bone marrow reserve
Hemoglobin≥80 g/L
Absolute neutrophil count≥1.0×109/L
Platelet≥50×109/L,
Creatinine≤1.5×upper limit of the normal range (ULN)
Cardiac ejection fraction≥50%
Saturation of Pulse Oxygen>92%
Total bilirubin≤1.5×ULN
Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN
Exclusion
Exclusion Criteria:
Malignant tumors other than B-Non-Hodgkin's lymphoma within 5 years prior toscreening, except cervical carcinoma in situ, basal cell or squamous cell skincancer, local prostate cancer after radical surgery, and breast ductal carcinoma insitu after radical surgery;
Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or treponemapallidum infection ;
Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease needtreatment;
Female subjects who have been pregnant or breastfeeding, or who plan to conceiveduring or within 1 year after treatment, or male subjects' partner plans to conceivewithin 1 year after their cell transfusion;
Active or uncontrolled infections requiring systemic treatment within 14 days beforeenrollment;
Patients who have been previously infected with tuberculosis;
Administered Corticosteroids and/or other immunosuppressants within 7 days beforeapheresis. and 5 days before the infusion of C-CAR039;
Patients with central nervous system involvement;
Study Design
Study Description
Connect with a study center
Peking University Cancer Hospital
Beijing,
ChinaSite Not Available
Peking University Cancer Hospital
Beijing 1816670,
ChinaSite Not Available

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