B cell malignancy
Conditions
Interventions
Case series:RPM CD19-mbIL15-CAR-T cell infusion
Sponsors
Ningbo First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be enrolled: 1. Volunteer to participate in the clinical study; I or the legal guardian fully understand and know the study and sign the informed consent form (ICF); willing to follow and complete all the trial procedures; 2. Patients aged 18-70 years old; 3. Patients with B-cell malignant tumor with CD19 + have no suitable treatment at present; (1) Relapsed or refractory acute lymphoblastic leukemia (all) may be incompatible with hematopoietic stem cell transplantation for the following reasons: Age; Excessive tumor load or combined diseases; No suitable donor (2) CD19 + follicular lymphoma; At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); The time from the last chemotherapy to disease progression was less than 6 months (the interval between the last progression was less than 6 months); (3) Mantle cell lymphoma; At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); After the last systematic treatment (chemotherapy, monoclonal antibody, etc.), the disease progressed; Recurrence occurred after autologous SCT. (4) Relapsed lymphoblastic leukemia (PLL) At least one treatment has residual lesions, which is not suitable for hematopoietic stem cell transplantation; (5) CD19 + diffuse large B-cell lymphoma; At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); The clinical stage was stage III or IV; The time from the last chemotherapy to progression was less than 6 months (the interval between the last progression was less than 6 months); Disease progression after the last systemic treatment (chemotherapy, monoclonal antibodies, etc.) 4. Patients with KPS score > 60; 5. Patients with an expected survival time of at least 12 weeks; 6. Patients with sufficient venous access (single or venous blood collection) and no other contraindications for blood cell separation; 7. Patients with lymphoma, according to the revised evaluation of the efficacy of malignant lymphoma (Lugano criteria, 2018), at least one measurable lesion: the long axis of the lesion = 1.5 cm, or the long axis of 1.0-1.5 cm and the minor axis = 1.0 cm; 8. During screening, the patients should meet the following requirements in laboratory examination, and have not received cell growth factor within 7 days before screening hematology evaluation (G-CSF / peg-csf needs to be separated by 2 weeks): 1 (1) The absolute value of neutrophils in patients without bone marrow involvement was = 1.5 × 10 ^ 9 / L, and that in patients with bone marrow involvement was = 1.0 × 10 ^ 9 / L; (2) Hemoglobin >=90 g/L (without red blood cell transfusion within 14 days), and hemoglobin = 75 g / L in patients with bone marrow involvement; (3) Platelet >=50x10^9/L; (4) Absolute lymphocyte (ALC) >=0.5x10^9/L; (5) Serum total bilirubin =60 ml/min. 9. The serum pregnancy test of women of childbearing age must be negative.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions are not eligible for this trial: 1. Patients with allergic history to any component of cell products; 2. Patients allergic to cetuximab; 3. Patients who have previously used any car T cell products or other genetically modified T cell therapy; 4. Patients who have received autologous or allogeneic hematopoietic stem cell transplantation within 3 months; 5. Patients with other malignancies (except basal cell carcinoma of skin, carcinoma in situ of breast / cervix, and other malignant tumors that have not been treated and effectively controlled in the past five years); and; 6. Patients with severe active infection (except simple urinary tract infection and bacterial pharyngitis) within 72 hours prior to the infusion of RPM cd19-mbil15-car-t cells need intravenous antibiotic therapy. However, prophylactic antibiotics, antiviral and antifungal treatment are allowed; 7. Patients who have received continuous systemic steroids or other immunosuppressants before monoculture or within 14 days before rpm cd19-mbil15-car-t cell therapy, except those who have recently or currently used inhaled steroids; 8. Patients with hepatitis B (HBsAg positive and / or HBcAg positive and HBV DNA > 103 copies) and hepatitis C (hepatitis C antibody positive); 9. Syphilis, T cell virus, human immunodeficiency virus (HIV) infection (HIV positive), CMV and EBV positive patients; 10. In patients with hyponatremia and / or hypokalemia, serum sodium nci-ctcae version 4.03 grade 1), except for alopecia and pigmentation; 16. Patients who participated in other intervention clinical trials within 3 months before administration; 17. Women who have been pregnant, prepared for pregnancy during the trial, or are breast-feeding; 18. During the study period, women of childbearing age and fer
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS);Overall Survival (OS);Disease Control Rate (DCR);Duration of Response (DOR); | — |
Primary
| Measure | Time frame |
|---|---|
| Objective Remission Rate (ORR);Safety; | — |
Countries
China
Contacts
Public ContactGuifang Ouyang
Ningbo First Hospital
Outcome results
None listed