B-cell non Hodgkin's lymphoma
Conditions
Interventions
Case series:None
Sponsors
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients voluntarily signed the informed consent and were able to complete the research procedures and follow-up examinations and treatments; 2. Aged 18 to 75 years, no gender limitation; 3. Aggressive NHL diagnosed according to the 2016 WHO classification, CD37 positive, CD19 positive or CD37/CD19 double positive, relapsed or refractory after receiving 2 or more lines of therapy, including previous CD19CAR-T Patients who relapse after treatment or CD19ADC antibody therapy and those who relapse after autologous hematopoietic stem cell transplantation are as follows: (1) Diffuse large B cell lymphoma (DLBCL) unspecified type (NOS), T cell/histiocytic rich large B cell lymphoma, EBV positive diffuse large B cell lymphoma in the elderly , primary mediastinal large B-cell lymphoma (PMBCL), chronic inflammation-associated DLBCL, follicular lymphoma (FL) transformed large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 Rearranged and high-grade B-cell lymphoma - unspecified; (2) Refractory is defined as: 1) No response to the last treatment, including: the best response to the last treatment regimen is disease progression (PD); at least 4 courses of first-line treatment/at least 2 courses of last-line treatment (2 lines and above) The best The curative effect is stable disease (SD), and the SD maintenance time after the last dose does not exceed 6 months; 2) Not suitable for autologous hematopoietic stem cell transplantation (ASCT), or refractory to ASCT, including: intolerance to high-dose chemotherapy; disease progression or recurrence within 1,000/mm3; (2) The absolute value of lymphocytes (ALC) >= 100/mm3; (3) Platelets (PLT) >= 50,000/mm3. 8. Have suitable organ function and meet the following criteria (except for abnormal liver function due to tumor infiltration): (1) Aspartate aminotransferase (AST) = 60 mL/min (Cockcroft and Gault formula); (5) Possess the lowest level of lung reserve, defined as
Exclusion criteria
Exclusion criteria: 1. Active central nervous system (CNS) lymphoma (patients with symptoms of CNS disease must undergo lumbar puncture and MRI to exclude CNS lymphoma); 2. Screening patients who received chemotherapy within 2 weeks before enrollment, except for the following conditions: (1) Pretreatment chemotherapy prescribed by the protocol; (2) Intrathecal chemotherapy for prevention of CNS (must be stopped 1 week before PMC930 BiCAR-T cell infusion). 3. PMC930 BiCAR-T cells are planned to undergo autologous stem cell transplantation (ASCT) within 6 weeks before the infusion. 4. Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT). 5. The patient is known to have systemic vasculitis (such as Wegener's granulomatosis, polyarteritis nodosa, systemic lupus erythematosus, etc.), combined with active or uncontrolled autoimmune diseases (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (such as HIV infection or serious infectious diseases, etc.). 6. Hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody (HCV-Ab) positive, Treponema pallidum antibody (TP-Ab) positive, human immunodeficiency virus antibody (HIV-Ab) positive, T cell virus antibody (HTLV-Ab) positive ) is positive and meets one of the criteria. 7. Received major surgery that was assessed as unsuitable for inclusion by the investigator within 4 weeks before screening; 8. Patients with active malignant tumors at the same time (except non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer that has been clearly treated by radiotherapy or surgery); past history of malignant tumors, and the disease has been cured for >= 2 years. patients can be enrolled; 9. The patient's heart meets any of the following conditions: (1) Left ventricular ejection fraction (LVEF) =450ms for men and >=470ms for women (QTcB=QT/RR1/2); (4) Uncontrolled hypertension (systolic blood pressure >=140mmHg and/or diastolic blood pressure >=90mmHg) or pulmonary hypertension or unstable angina; (5) Have myocardial infarction or bypass or stent surgery within 12 months before administration; (6) Clinically significant valve disease; (7) Other heart diseases judged by the investigator to be unsuitable for enrollment. 10. Clinically significant pleural effusion. 11. Those with a history of epilepsy, cerebrovascular ischemia/bleeding, cerebellar disease or other active central nervous system diseases. 12. Lymphoma involving the atrium or ventricle. 13. There is a clinical emergency (such as intestinal obstruction or vascular compression, etc.) that requires urgent treatment due to the obstruction or compression of the lymphoma tumor at the time of screening. 14. Those with a history of deep vein thrombosis or pulmonary embolism within 6 months before screening. 15. Those with known history of hypersensitivity to the ingredients of the preparation used in the test. 16. Received live vaccine within 6 weeks before planned conditioning treatment. 17. There is evidence of uncontrollable serious active infection (such as sepsis, bacteremia, fungemia, viremia, etc.) at the time of screening. 18. Those whose life expectancy is les
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease recurrence rate; | — |
Countries
China
Contacts
Public ContactMei Heng
Union Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology
Outcome results
None listed