B-Cell Malignancies
Conditions
Interventions
Case series:Anti-CD19-CAR transduced T cells
Sponsors
Shenzhen Innovation Immunotechnology Co., Ltd
Eligibility
Sex/Gender
All
Age
1 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Patients must have a CD19+ B cell malignancy, including relapsed or refractory B cell leukemia and B cell lymphoma; 2. Patients with CD19+ B cell malignancies are not able to receive standard treatments and willing to participate in the trial; 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis; 4. Patients are not eligible for autologous stem-cell transplantation (SCT) or relapsed after autologous stem cell transplantation; 5. Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease and no longer taking immunosuppressive agents during the treatment; 6. Willing to sign a durable power of attorney; 7. Able to understand and sign the Informed Consent Document; 8. Life expectancy > 3 months; 9. There are no obvious dysfunctions in heart , liver and kidney, and the functions of vital organs are normal; 10. Serology (1) Seronegative for HIV antibody (2) Seronegative for hepatitis B virus (HBV) and hepatitis C virus (HC Chemistry: (1)serum glutamic pyruvic transaminase/glutamic oxalacetic transaminase= 5 times of ULN ; (2)serum creatinine= 1.6mg/dl; (3)TBIL=1.5 mg/dl; 12. More than three weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less; 13. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram; 14. More than 30 days must have elapsed since monoclonal antibody therapy administered prior to apheresis.
Exclusion criteria
Exclusion criteria: 1. Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression; 2. Patients that have active hemolytic anemia; 3. Patients with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of brain metastases, or any residual intracranial implants; 5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; 6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease); 7. Concurrent opportunistic infections; 8. Concurrent Systemic steroid therapy; 9. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 10. Patients with central nervous system (CNS) metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions); 11. Women of child-bearing potential who are pregnant or breastfeeding; 12. Patients with cardiac atrial or cardiac ventricular lymphoma involvement; 13. Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment; 14. Previous treatment with any gene therapy products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with CD19+ B-cell malignancies.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if the treatment regimen can result in clinical regression of B-cell malignancies in the patients as described above.; | — |
Countries
China
Contacts
Public ContactXimin Fang
Shenzhen Children's Hosipital
Outcome results
None listed