Acute Leukemia
Conditions
Keywords
Leukemia, CART CD19, Chemotherapy Resistant, Chemotherapy Refractory, CD19 +, Lymphoma
Brief summary
The purpose of this study is to evaluate the safety and efficacy of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with chemotherapy resistant or refractory CD19+ acute Leukemia.
Interventions
BIOLOGICALCD19-CAR-T2 Cells
Sponsors
Chinese Academy of Sciences
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
Guangdong Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient with relapsed and/or refractory CD19 positive B-cell acute leukemia * Eastern Cooperative Oncology Group (ECOG) performance status 《 3 * ALT/ AST 《 3x normal * Bilirubin \< 2.0 mg/dl * Creatinine \< 2.5 mg/dl and less than 2.5x normal for age * LVEF》 45% * Accept white blood cell collection * Provide informed consent
Exclusion criteria
* Previous treatment with investigational gene or cell therapy medicine products * Solitary extramedullary relapse * Active hepatitis B , hepatitis C or HIV infection * Uncontrolled active infection * Presence of grade 2-4 acute or extensive chronic GVHD * Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma, * Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc. * Any uncontrolled active medical disorder that would preclude participation as outlined. * Received non-diagnostic purposes major surgery within the past 4 weeks * Participated in any other clinical study within the past 4 weeks * Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist. * Pregnancy or breast-feeding women * Use of prohibited drugs: * Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion * Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion * GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion * Chemotherapy: i. The following drugs must be stopped \> 1 week prior to CTL019 infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate \<25 mg/m2, cytosine arabinoside \< 10 mg/m2/day, asparaginase; ii. The following drugs must be stopped \> 4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside \> 100 mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs * Any situation that may increase the risk of the test or interfere with the test results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose(MTD) of CD19 positive relapsed/ refractory acute leukimia treated wtih CD19-CAR-T2 cells | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 12 months | Adverse events and laboratory abnormalities (type, frequency and severity) |
| Overall Response Rate | 12 months | Overall Response Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis. |
Countries
China
Contacts
Primary ContactXin Du, Dr.
Backup ContactPeng Li, Dr.
Outcome results
None listed