relapsed and refractory CD19-positive Diffuse large B-cell lymphoma and Follicular lymphoma
Conditions
Interventions
Case series:anti-CD19 CAR-T cells, intravenous inoculation
Sponsors
Fudan University Zhongshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 70 Years Old Male and female; (2) Expected survival > 12 weeks; (3) Clinical performance status of ECOG score 0-1; (4) Pathology demonstrated that CD19-poitive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions: 1) Relapsed and refractory CD19-positive Diffuse large B-cell lymphoma and Follicular lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR; 2) Disease recurrence after stem cell transplantation, and at least 1 years after stem cell transplantation. (5) Accessible to intravenous injection, and no white blood cell collection contraindications; (6) At least 1 measurable tumor foci according to the IWG treatment response criteria; (7) Patients who meet the following conditions: 1) Creatinine 50%, no pericardial effusion and no pleural effusion (ECHO examination); 3) Baseline oxygen saturation>92%; 4) Total bilirubin=1.5xULN; ALT/AST=2.5x normal. (8) Able to understand and sign the Informed Consent Document.
Exclusion criteria
Exclusion criteria: (1) Accompanied by other malignant tumor; (2) Active hepatitis B, hepatitis C, syphilis, HIV infection; (3) Suffering severe cardiovascular or respiratory disease; (4) Any other diseases could affect the outcome of this trial; (5) Any affairs could affect the safety of the subjects or outcome of this trial; (6) Pregnant or lactating women, or patients who plan to be pregnancy during or after treatment; (7) Occurrence of infection uncontrolled or requiring systemic treatment 14 days prior to assignment; (8) Patients who are accounted by researchers to be not appropriate for this test; (9) Received CAR-T treatment or other gene therapies before assignment; (10) Patients with symptoms of central nervous system; (11) Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0;Clinical performance status of ECOG score;Laboratory examination;electrocardiogram;vital signs;physical examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: Duration of CAR-positive T cells in circulation, including the highest concentration of amplification (Cmax), the time to reach the highest concentration (Tmax) and the area under the curve for 90 days (AUC90d);PD parameters: The clearance of CD19-positive B cells in peripheral blood at the detected time points;Overall remission rate including complete response and Partical response defined by the standard response criteria for malignant lymphoma; | — |
Countries
China
Contacts
Public ContactPeng Liu
Zhongshan Hospital, Fudan University
Outcome results
None listed