Leukemia, Lymphocytic, Chronic, B-Cell
Conditions
Brief summary
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
Detailed description
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.
Interventions
BIOLOGICALCAR-T
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
Sponsors
iCarTAB BioMed Inc.
Huaian first people's hospital
Kai Lin Xu; Jun Nian Zheng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age≥3 at the time of consent * Survival time\>12 weeks * B cell hematological malignancies by pathological examination * Chemotherapy failure or recurrent B cell malignancy * Creatinine\< 2.5mg/dl * Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level * Karnofsky Performance Status\>50% at the time of screening * Bilirubin\<2.0mg/dl * Adequate pulmonary, renal, hepatic, and cardiac function * Fail in autologous or allogenic haemopoietic stem cell transplantation * Free of leukocytes removal contraindications
Exclusion criteria
* Pregnant or nursing women * Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening * Previous treatment with any gene therapy product * Abnormal vital signs * Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2 * General infection or local severe infection, or other infection that is not controlled * Dysfunction in lung, heart, kidney and brain. * Severe autoimmune diseases * other symptoms that are not applicable for CAR-T
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CAR-T cells persistence in peripheral blood | 12 months | The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B cell number and immunoglobulins in peripheral blood | 12 months | The number of B cells and immunoglobulins in peripheral blood will be evaluated by routine methods |
Countries
China
Contacts
Primary ContactJiang Cao, M.D., Ph.D.
Backup ContactJunNian Zheng, M.D., Ph.D.
Outcome results
None listed