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.
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 and determine the best dosage.
Interventions
BIOLOGICALIM19 CAR-T
T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
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
3 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with CD19+ Refractory or Relapsed B-ALL（At least 2 prior combination chemotherapy regimens） 2. To be aged 3 to 75 years 3. Blast in blood ≤ 30% 4. ECOG score ≤2 5. 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. 6. Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
1. Intracranial hypertension or unconsciousness 2. Respiratory failure 3. CD19 negative 4. Disseminated intravascular coagulation 5. ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x normal value 6. Hematosepsis or Uncontrolled active infection 7. Uncontrolled diabetes 8. Abalienation; 9. WHO Sscore \>3 10. Patients in pregnancy or breast-feeding period 11. Previously treatment with any gene therapy products 12. Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial 13. 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
Outcome results
None listed