Leukemia, Lymphoma
Conditions
Keywords
CD22, CAR-T, Leukemia, Lymphoma
Brief summary
The study will evaluate safety and efficacy of the CD22-targeted chimeric antigen receptor modified-T cell(CAR-T) cells in the treatment of B-cell Malignancies.
Detailed description
Clinical success with chimeric antigen receptor (CAR)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. Despite anti-CD19 CAR-T exhibited the ability to re-induce remissions for many patients with relapsed and refractory B cell malignancies, a part of those patients will relapse with CD19-negative malignancies. CD22 is a type I transmembrane protein expressed on most mature B lymphocyte in the B cell malignancies，and plays a significant role in signal transduction pathway. The investigators design and conduct this trial to test the safety and effectiveness of CD22-targeted CAR-T.
Interventions
BIOLOGICALAnti-CD22-CAR-transduced T cells
a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
Sponsors
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18-65 years 2. Patients with Cluster of Differentiation 22(CD22) positive B cell malignancies as confirmed by flow cytometry 3. Refractory or relapsed B cell-acute lymphoblastic leukemia 4. No available curative treatment options (such as hematopoietic stem cell transplantation) 5. Stage III-IV disease 6. Creatinine \< 2.5 mg/dl 7. Aspartate transaminase-alanine transaminase ratio \< 3x normal 8. Bilirubin \< 2.0 mg/dl 9. Karnofsky performance status \>= 60 10. Expected survival time \> 3 months 11. Adequate venous access for apheresis 12. Ability to understand and provide informed consent
Exclusion criteria
1. Pregnant or lactating women 2. Patients requiring T cell immunosuppressive therapy 3. Active central nervous system leukemia 4. Any concurrent active malignancies 5. Patients with a history of a seizure disorder or cardiac disorder 6. Previous treatment with any immunotherapy products 7. Patients with human immunodeficiency virus, hepatitis B or C infection 8. Uncontrolled active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03 | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Complete Remission Rate (ORR) | 2 years |
| Disease response(CR, CRi) | 2 years |
| CART cells persistence in vivo | 2 years |
Countries
China
Contacts
Primary ContactLiangding Hu, M.D.
Outcome results
None listed