The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/CD22 bispecific chimeric antigen receptors (CARs) T cell therapy for CD19-positive Acute Lymphoblastic Leukemia.
Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/ CD22 CAR-T cells in treating patients with CD19-positive Acute Lymphoblastic Leukemia. Secondary Objectives 1. To determine in vivo expression, dynamics and persistency of anti-CD19/CD22 CAR-T cells. 2. To determine in vivo expression of CD19-positive B cells. 3. To access the complete remission rate (ORR) in patients with ALL with 3 months after CD19/CD22 CAR-T cells infusion. 4. To investigate the favorable CD19/CD22 CAR-T cells dose and dosage regimen for the Phase II Clinical Trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
30mg/m2/d
500mg/m2/d
Henan Province of TCM
Zhengzhou, Henan, China
RECRUITINGSafety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 6 months
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time frame: 8 weeks
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Time frame: 6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.