B-Cell Leukemia, B-Cell Lymphoma
Conditions
Brief summary
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
Detailed description
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Interventions
BIOLOGICALAutologous CD19-targeting CAR T cells
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
Sponsors
The Second Hospital of Hebei Medical University
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The treat history meeting the following criteria: * Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; * Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; * One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients. 2. There is a measurable lesions before treatment at least; 3. ECOG score≤2; 4. To be aged 1 to 70 years; 5. More than a month lifetime from the consent signing date
Exclusion criteria
* Serious cardiac insufficiency, left ventricular ejection fraction\<50; * Has a history of severe pulmonary function damaging; * Merging other malignant tumor; * Merging uncontrolled infection; * Merging the metabolic diseases (except diabetes); * Merging severe autoimmune diseases or immunodeficiency disease; * patients with active hepatitis B or hepatitis C; * patients with HIV infection; * Has a history of serious allergies on Biological products (including antibiotics); * Happened in 3 \ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor load | Up to 24 months | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CAR T cell persistence | Up to 24 months | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| B cell number and immunoglobulins in peripheral blood | Up to 12 months | The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods |
Countries
China
Contacts
Primary Contactjianqiang li, PhD & MD
Backup ContactJianmin Luo, PhD & MD
Outcome results
None listed