B cell malignancy
Conditions
Interventions
experimental group:Treat with RPM CD19-mbIL15-CAR-T cells
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
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: 1) age 2) Excessive tumor load or combined diseases; 3) No suitable donor (2) CD19+ follicular lymphoma; 1) At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); 2) 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) Disease progression after the last systemic treatment (chemotherapy, monoclonal antibodies, etc.). (3) Mantle cell lymphoma; 1) At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); 2) After the last systematic treatment (chemotherapy, monoclonal antibody, etc.), the disease progressed; 3) 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; 1) At least 2-line chemotherapy regimen (excluding monoclonal antibody (CD20 monoclonal antibody) was used before treatment); 2) The clinical stage was stage III or IV; 3) The time between the last chemotherapy and progression was less than 6 months (the interval between the last progression was less than 6 months); 4) Disease progression after the last systemic treatment (chemotherapy, monoclonal antibodies, etc.) 5) High-grade B cell lymphoma (with MYC and Bcl2 and/or Bcl6 rearrangement and high-grade B cell lymphoma unspecified type) or Burkitt's lymphoma; 6) The best efficacy of at least 4 courses of first-line treatment (2 lines and above) is disease stability (SD) and the SD maintainance time after the last administration is no more than 6 months. 4. Patients with Karnofsky performance scale (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) The absolute value of neutrophils in patients without bone marrow involvement >=1.5x10^9/L, and that in patients with bone marrow involvement >=1.0x10^9/L; (2) Absolute lymphocyte (ALC) >=0.5x10^9/L; (3) Hemoglobin >= 90 g/L (without red blood cell transfusion within 14 days), and hemoglobin >=75 g/L in patients with bone marrow involvement; (4) Platelet >= 50x10^9/L; (5) Serum total bili
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 in 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) after lymphodepleting chemotherapy treatment or within 72 hours after RPM CD19-mbIL15-CAR-T cells infusion, need to be treated with intravenous antibody; allowed using 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 > 10^2 copies) and hepatitis C (hepatitis C antibody positive); 9. Syphilis, T cell virus, human immunodeficiency virus (HIV) infection (HIV positive); 10. In patients with hyponatremia and/or hypokalemia, serum sodium grade 1 of NCI-CTCAE version 4.03), 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 child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Maximum Tolerated Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Remission Rate (ORR);Progression Free Survival (PFS);Overall Survival (OS);Disease Control Rate (DCR);Duration of Response (DOR);Cytokine Characteristics; | — |
Countries
China
Contacts
Public ContactLiang Aibin
Tongji Hospital of Tongji University
Outcome results
None listed