Adult Acute Lymphoblastic Leukemia in Remission, B-cell Adult Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Hematopoietic/Lymphoid Cancer, Refractory Chronic Lymphocytic Leukemia
Conditions
Brief summary
This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.
Detailed description
Primary objectives 1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation
Interventions
BIOLOGICALanti-CD19 CAR-T
Ex vivo-expanded autologous T cells modified to express CD19 CAR
DRUGFludarabine
Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
DRUGCyclophosphamide
Patients were given cyclophosphamide 500mg/m2/day on day -4.
Sponsors
Hrain Biotechnology Co., Ltd.
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 5 Years to 70 Years, Male and female; * Expected survival \> 12 weeks; * Performance score 0-2; * Histologically confirmed as CD19-positive lymphoma/leukemia and who meet one of the following conditions; Patient receive at least 2-4 prior combination chemotherapy regimens (not including single agent monoclonal antibody therapy) and fail to achieve CR; or have disease recurrence; or not eligible for allogeneic stem cell transplantation; or disease responding or stable after most recent therapy but refused further treatment; Disease recurrence after stem cell transplantation; Diagnosis as lymphoma, but refuse conventional treatment such as chemotherapy, radiation, stem cell transplantation and monoclonal antibody therapy * Creatinine \< 2.5 mg/dl; * ALT/AST \< 3x normal; * Bilirubin \< 2.0 mg/dl; * Adequate venous access for apheresis, and no other contraindications for leukapheresis; * Take contraceptive measures before recruit to this trial; * Written voluntary informed consent is given.
Exclusion criteria
* Patients with symptoms of central nervous system * Accompanied by other malignant tumor * Active hepatitis B or C, HIV infection * Any other diseases could affect the outcome of this trial * Suffering severe cardiovascular or respiratory disease * Poorly controlled hypertension * A history of mental illness and poorly controlled * Taking immunosuppressive agents within 1 week due to organ transplantation or other disease which need long-lasting administration * Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * Reaching a steady dose if receiving anticoagulant therapy before assignment * Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * Pregnant or lactating women * Subject suffering disease affects the understanding of informed consent or comply with study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - incidence of adverse events defined as dose-limited toxicity | 180 days | incidence of adverse events defined as dose-limited toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall complete remission rate | 1 year | Overall complete remission rate |
| Duration of remission | 1 year | Duration of remission |
Countries
China
Contacts
Primary ContactKang Yu, M.D.
Outcome results
None listed