Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Complete remission rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
CD22 CAR-T
Enrolled patients will receive three escalating doses of autologous CAR-T.
Intervention: CD22 CAR-T (Biological)
Outcomes
Primary Outcomes
Complete remission rate
Time Frame: 12 months
The B cells in peripheral blood of all enrolled patients will be monitored every week
Secondary Outcomes
No secondary outcomes reported
Investigators
Kai Lin Xu; Jun Nian Zheng
President
Xuzhou Medical University