B Cell Leukemia, B Cell Lymphoma
Conditions
Keywords
CAR-T
Brief summary
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).
Interventions
BIOLOGICALCD19-CAR-T2 Cells
CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma * Eastern Cooperative Oncology Group (ECOG) performance status \<2 * ALT/ AST \<3 x normal * Bilirubin \< 2.0 mg/dl * Creatinine \< 2.5 mg/dl and less than 2.5x normal for age * LVEF\< 45% * Accept white blood cell collection * Provide informed consent
Exclusion criteria
* Previous treatment with investigational gene or cell therapy medicine products * Active hepatitis B , hepatitis C or HIV infection * Uncontrolled active infection * Presence of grade 2-4 acute or extensive chronic GVHD * Any uncontrolled active medical disorder that would preclude participation as outlined. * Received non-diagnostic purposes major surgery within the past 4 weeks * Participated in any other clinical study within the past 4 weeks * Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * Pregnancy or breast-feeding women * Use of prohibited drugs: * Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion * Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion * GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion * Any situation that may increase the risk of the test or interfere with the test results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 3 months | Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 months | — |
| Adverse Events | 12 months | — |
| OS | 1 year | overall survival |
| DFS | 1 year | disease-free survival |
Countries
China
Outcome results
None listed