Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
Conditions
Brief summary
Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).
Detailed description
When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days. Extra blood will be drawn to measure the persistence of CART30 in vivo.
Interventions
BIOLOGICALCART30
Cells will be infused 1 day after the completion of conditioning regimen.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment. * Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy. * Karnofsky or Lansky score greater than 60%. * Expected survival\>12 weeks. * Creatinine\<2.5mg/dl. * ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 fold normal. * Bilirubin\<2.5mg/dl. * Pulse oximetry of \>90% on room air. * Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin. * Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry. * Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
Exclusion criteria
* Active infection such as hepatitis B or C. * Receive anti-CD30 antibody-based therapy within recent 6 weeks. * Current use of systemic corticosteroids. * Pregnant or lactating. * Confirmed tumor in pulmonary and archenteric tissues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of related adverse events | untill week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor response to CART30 cell infusions | Up to 24 weeks | Evaluated mainly by computed tomography scanning |
Other
| Measure | Time frame | Description |
|---|---|---|
| in vivo existence of CART30 | 1 year | Measure mainly by the changes of CAR molecule levels in blood |
Countries
China
Contacts
Primary ContactWeidong Han, Ph.D
Backup ContactQuanshun Wang, Ph.D
Outcome results
None listed