B Cell Leukemia, B Cell Lymphoma
Conditions
Brief summary
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. ICAR19 CART used the second generation of CART designation. In this study, the participants will receive several doses of autologous ICAR19 T cells and the investigators will determine the safety and therapeutic effects of these cells.
Interventions
BIOLOGICALICAR19 CAR-T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
Sponsors
Weifang People's Hospital
Immune Cell, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
CD19 positive leukemia and lymphoma，relapsed and/or refractory： * survival\>12 weeks; * FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin; * LVEF≥50%; * Creatinine\<2.5mg/dl; * Bilirubin\<2.5mg/dl; * ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal; * At least 7 days after last chemotherapy; * provide with informed consent.
Exclusion criteria
* Active clinically significant CNS dysfunction * Pregnant or breast-feeding women. * Uncontrolled active infection including hepatitis B or C. * HIV positive. * Use of systemic steroids within 72 hours. * Allogeneic lymphocyte treatments within recent 6 months. * Any uncontrolled active medical disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the safety of ICAR19 CAR-T cells | 2 years | To assess the adverse events of ICAR19 T cells infusion in patients with CD19+ malignancies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the anti-tumor effect of ICAR19 CAR-T cells | 3 years | Assess for the therapeutic effects of ICAR 19 CAR-T cells in CD19-expressing leukemia and lymphoma |
| Survival time of ICAR19 T cells in vivo. | 5 years | To measure the survival time of ICAR19 CAR-T cells in vivo, extra blood will be drawn from patients receive ICAR19 T cells infusion in the follow-up time |
Countries
China
Contacts
Primary ContactXiulian Sun, MD.,Ph.D
Outcome results
None listed