refractory and relapsed B-cell acute lymphoblastic leukemia/invasive B-cell non-Hodgkin's lymphoma
Conditions
Interventions
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and be willing and able to comply with the visits, treatment plans, laboratory tests, and other requirements of the study as specified in the test schedule; 2. Aged at least 14 years old, male or female; 3. Eastern Tumor Cooperative Group (ECOG) physical status score 0~2 points; 4. Life expectancy = 3 months; 5. Confirmed CD19-positive r/r B-ALL and/or B-NHL patients; 6. The patient's tumor condition meets the following conditions: (1) If the patient is NHL, at least one measurable lesion (IWG response standard Cheson 2014) is used as the basis for evaluation: for intra-junction lesions, the long diameter should be =1.5 cm and the short diameter should be =1.0 cm; for extranodal lesions, long diameter Should be =1.0 cm; (2) If the patient is ALL, the proportion of myeloid leukemia cells in screening is =5%; 7. The functional level of vital organs must meet the following criteria: (1) Serum creatinine = 1.5 times the upper limit of normal (ULN); (2) ALT/AST=2.5 ULN; total bilirubin =1.5 ULN; (3) Hemodynamic stability and left ventricular ejection fraction (LVEF) = 45% (4) hemoglobin = 60g / L; platelet count = 20 × 10^9/L; absolute neutrophil count (ANC) = 1.0 × 10^9/L; (5) Minimum lung function reserve is required (breathing difficulty is not higher than level 1 and oxygen saturation >1% under indoor conditions); 8. Clinically significant AEs related to chemotherapy, surgery, radiation therapy or targeted therapy have been alleviated to =1 (except for hair loss); 9. Ability to obtain sufficient peripheral blood through the vein, no other contraindications for lymphocyte collection; 10. Males with reproductive ability or female patients with the possibility of pregnancy must meet: 1) surgical sterilization; 2) female patients with menopause = 2 years or negative screening for serum pregnancy test; 3) consent during and after the trial Use highly effective contraceptive methods within 1 year, such as oral contraceptives, intrauterine devices, libido or barrier contraception combined with spermicides. Those who do not meet one of the above conditions may not be selected as a patient.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of other malignancies, except those who have undergone radical treatment and have no disease recurrence 2 years ago, except for patients with non-melanoma skin cancer or carcinoma in situ (eg cervical cancer, bladder cancer, breast cancer); 2. The following conditions exist: (1) patients with Richter syndrome; (2) Burkitt's lymphoma/leukemia or chronic myeloid leukemia blast crisis (p210 BCR-ABL+) patients; 3. Patients who have received targeted therapy for CD19, CAR-T therapy, or other genetically modified T cell therapy; 4. Those who have undergone major surgery within 4 weeks prior to enrollment, or who intend to undergo surgery during the study period; 5. Patients with central nervous system (CNS) involvement; 6. Patients with HIV infection, active hepatitis B or active hepatitis C (anti-HCV positive); 7. Patients with severe heart disease, including but not limited to: New York Heart Association Classification (NYHA) grade 3 or 4 congestive heart failure; uncontrolled angina or arrhythmia; any uncontrolled high blood pressure, hypotension, Severe cardiovascular disease; 8. Patients with uncontrolled systemic fungi, bacteria, viruses or other infections during screening; 9. Receiving systemic glucocorticoid therapy, failed to terminate the drug 72 hours before the start of treatment with CAR-T; 10. A known history of allergies or a history of hypersensitivity to CD19 CAR-T product components; 11. Any other medical condition that may interfere with the assessment of the safety and efficacy of the study drug; 12. Pregnant and lactating women; 13. Patients who participated in other drug clinical trials or who participated in other drug clinical trials during the study period within one month prior to the study; 14. The investigator judges other circumstances that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor response;Patient survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Classification of cell;CD19 CAR-T cell survival in vivo; | — |
Countries
China
Contacts
Public ContactChunkang Chang
Shanghai Sixth People's Hospital
Outcome results
None listed