Acute Lymphoblastic Leukemia(ALL) Clinical Trial
Official title:
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）
| Verified date | September 2020 |
| Source | Peking University People's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | April 30, 2021 |
| Est. primary completion date | February 28, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University Institute of Hematology | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University People's Hospital | Cellular Biomedicine Group Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | TEAEs | TEAEs evaluated after C-CAR011 infusion | 2 months | |
| Primary | GVHD | GVHD evaluated after C-CAR011 infusion | 2 months | |
| Secondary | Recurrence rate | Recurrence rate | 6 and 12 months | |
| Secondary | OS | Overall survival (OS) after C-CAR011 infusion | 12 months | |
| Secondary | PFS | Progression free survival(PFS)after C-CAR011 infusion | 12 months | |
| Secondary | Remission rate | MRD negative after C-CAR011 infusion | 2 weeks to 3 months |