Leukemia
Conditions
Brief summary
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-all.
Detailed description
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor to Patients With CD19+ B-cell leukemia or CD19+ B-ALL patients and determine the MTD,LTD and the best dosage.
Interventions
BIOLOGICALIM19 CAR-T
All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with CD19+ leukemia, meeting the following criteria * At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy) * Less than 1 year between last chemotherapy and progression * Not eligible or appropriate for allo-HSCT * To be aged 4 to 65 years * Estimated survival of ≥ 6 months, but ≤ 2 years * ECOG score ≤2 * Relapse after auto-HSCT * Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time. * Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
* History of epilepsy or other CNS disease * Patients have GVHD, which needs treatment with immunosuppressive agents * Patients with prolonged QT interval or severe heart disease * Patients in pregnancy or breast-feeding period * Uncontrolled active infection * Active hepatitis B or hepatitis C infection * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary * Previously treatment with any gene therapy products * Feasibility assessment during screening demonstrates \<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation * ALT /AST\>3 x normal value; Creatinine\> 2.5 mg/dl; Bilirubin \>2.0 mg/dl * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial * HIV infection * Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of study related adverse events | 2 years | defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 2 years | An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry |
Countries
China
Contacts
Primary ContactXin-an Lu, Dr.
Backup Contacthui liu, MD
Outcome results
None listed