Acute Lymphoblastic Leukemia(ALL)
Conditions
Keywords
Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell
Brief summary
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
Detailed description
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10\^6CAR+T cells/kg
Interventions
BIOLOGICALC-CAR011
CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)
Sponsors
Shanghai AbelZeta Ltd.
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 15-65 years old, male or female. * Volunteered to participate in this study and signed informed consent. * Meet the two populations above. * Histologically diagnosed as CD19+B-ALL. * 100% T lymphocytes of donor. * Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy. * Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias. * Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection. * Expected survival ≧ 3 months. * Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion criteria
* History of allergy to cellular products. * Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin\<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets\<20×109/L. * The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD. * Severe uncontrolled infection (mycotic, bacterial, virus and so on). * Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible. * The subjects were treated CART cells or DLI after HSCT. * Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation. * Any genetically modified T cell therapy. * History of heavy drinking, drug taking or mental disease. * Participated in any other clinical trial within one month prior to enrollment. * Women who are pregnant or lactating or have breeding intent in 6 months. * The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAEs | 2 months | TEAEs evaluated after C-CAR011 infusion |
| GVHD | 2 months | GVHD evaluated after C-CAR011 infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 6 and 12 months | Recurrence rate |
| OS | 12 months | Overall survival (OS) after C-CAR011 infusion |
| PFS | 12 months | Progression free survival（PFS）after C-CAR011 infusion |
| Remission rate | 2 weeks to 3 months | MRD negative after C-CAR011 infusion |
Countries
China
Outcome results
None listed