Study of Anti-CD22 CAR-T Cells Treating Leukemia Children

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

May 1, 2020

Primary Completion Date

April 3, 2024

Study Completion Date

April 3, 2024

Conditions
Acute Lymphoblastic LeukemiaAcute Lymphoblastic Leukemia, in RelapseRefractory Acute Lymphoblastic Leukemia
Interventions
BIOLOGICAL

Autologous humanized anti-CD22 chimeric antigen receptor T cells

CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In CD22 T cell clinical trials, CAR-T cells was given once. All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status. Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR T-cell infusion to determine the disease status.

Trial Locations (1)

100000

Beijing Boren Hospital, Beijing

All Listed Sponsors
lead

Beijing Boren Hospital

OTHER

NCT04340167 - Study of Anti-CD22 CAR-T Cells Treating Leukemia Children | Biotech Hunter | Biotech Hunter