Anaplastic Large Cell Lymphoma, Hodgkin Lymphoma
Conditions
Brief summary
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
Interventions
BIOLOGICALICAR30 T cells
T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 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
Masking description
None (Open Label)
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory: * Karnofsky or Lansky score \>50; * Expected survival\>12 weeks; * Hgb \> 8.0; * 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 fold normal; * Patients must sign an informed consent.
Exclusion criteria
* Pregnant or lactating; * Uncontrolled active infection including hepatitis B or C; * HIV positive; * Active clinically significant CNS dysfunction; * Current use of systemic steroids; * Heterogenous lymphocyte treatments within recent 6 months;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the safety of ICAR30 T cells | 2 years | To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure the anti-tumor effect of ICAR30 T cells | 3 years | To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. |
| Measure the survival time of ICAR30 T cells in vivo | 5 years | To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time. |
Countries
China
Contacts
Primary ContactXiulian Sun, MD.,Ph.D
Outcome results
None listed