CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies
- Conditions
- Recurrent or Refractory B Cell Malignancy
- Interventions
- Biological: CD22 CAR-T
- Registration Number
- NCT02794961
- Lead Sponsor
- Kai Lin Xu; Jun Nian Zheng
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CD22 CAR-T CD22 CAR-T Enrolled patients will receive three escalating doses of autologous CAR-T.
- Primary Outcome Measures
Name Time Method Complete remission rate 12 months The B cells in peripheral blood of all enrolled patients will be monitored every week
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Affiliated hospital of Xuzhou medical college
🇨🇳Xuzhou, Jiangsu, China