Recurrent or Refractory B Cell Malignancy
Conditions
Brief summary
CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.
Detailed description
CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.
Interventions
BIOLOGICALCD22 CAR-T
Autologous CAR-T cells with average 1\*10\^6 cells/kg body weight
Sponsors
iCarTAB BioMed Inc.
Kai Lin Xu; Jun Nian Zheng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Greater than four years of age * 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 * Bilirubin\<2.0mg/dl * Karnofsky Performance Status\>50% at the time of screening * Adequate pulmonary, renal, hepatic, and cardiac function * Fail in autologous or allogenic haemopoietic stem cell transplantation * Free of leukocytes removal contraindications * Voluntarily join CAR-T clinical trial * Understand and sign written informed consent
Exclusion criteria
* Pregnant or nursing women * Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening * Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated. * 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 |
|---|---|---|
| Complete remission rate | 12 months | The B cells in peripheral blood of all enrolled patients will be monitored every week |
Countries
China
Contacts
Primary ContactJiang Cao, M.D., Ph.D.
Backup ContactJunNian Zheng, M.D., Ph.D.
Outcome results
None listed