B-cell non-Hodgkin's lymphoma
Conditions
Interventions
Experimental group:GC012F treatment
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years(including cut-off value), no gender limit; 2. Relapsed or refractory B-cell non-Hodgkin's lymphoma: 3. (1) B-NHL confirmed by histopathology, including but not limited to the following subtypes: non-specific diffuse large B lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement (double/triple hit Lymphoma) (DHL/THL), primary mediastinal large B lymphoma, diffuse large B lymphoma transformed from follicular lymphoma, follicular lymphoma; marginal zone B cell lymphoma; mantle cell lymphoma; (2) For relapsed and refractory aggressive B-NHL, the subject must have been treated with anthracyclines and rituximab (or other CD20 targeted drugs), and have received at least two lines of treatment or Recurrence, non-remission or progression after auto-HSCT; (3) For relapsed and refractory indolent B-NHL, the subject must have been treated with anthracyclines and rituximab (or other CD20 targeted drugs), and have received at least two lines of treatment or autologous After hematopoietic stem cell transplantation (auto-HSCT) and within 730 days after last-line treatment, recurrence, no remission or progression; (4) If the subject has received CAR-T treatment in the past, the CAR-T cells previously infused must not be detected in the body or it has been more than 60 days since the most recent CAR-T reinfusion. 4. According to the Lugano response criteria of lymphoma (Cheson2014, see Appendix 1), there is at least one measurable lesion, and the lesions that have received radiotherapy before are regarded as measurable lesions and must be recorded as progress after the completion of radiotherapy: (1) The long diameter of nodular lesions is 15mm, and the short diameter is not considered; (2) Extranodal lesions (except lymph nodes or nodular lesions, including liver and spleen) with long diameter >=10mm, short diameter is not considered. 5. ECOG score = 90 days; 7. Positive expression of CD19 and/or BCMA in tumor tissue; 8. Good organ function reserve: (1) Creatinine clearance rate (Cockcroft-Gault method) > 60ml/min: Male creatinine clearance rate=[(140-age) x weight (kg)]/[0.818 x creatinine (umol/L)]; female creatinine clearance rate =[(140-age) x weight (kg)x 0.85]/[0.818 x creatinine (umol/L)]; (2) Serum ALT and AST 50% was diagnosed by echocardiography; (5) The basic index saturation in the indoor air environment is > 92%. 9. Sufficient bone marrow reserve, defined as: absolute value of neutrophils (ANC)> 1.0x10^9/L; absolute value of lymphocytes (ALC) >= 0.3x10^9/L; platelets (PLT) >= 50 x10^9/L; 10. Female patients of childbearing age must be in the non-lactating period, and the high-sensitivity serum pregnancy test during the screening period of fertile women must be negative. Approved contraceptive measures (such as intrauterine devices, contraceptives), male subjects also need to avoid sperm donation; 11. Venous access can be established, and peripheral blood mononuclear cells can be collected by the researcher's judgment; 12. Voluntarily sign the informed consent form; 13. The patient can communicate well with the researcher, is willing and able to follow the research plan, and complete the research in accordance with the research
Exclusion criteria
Exclusion criteria: 1. Active central nervous system violations; 2. Suffering from other malignant tumors, except for the following situations: cured non-melanoma skin cancer, cervical cancer in situ, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, other disease-free survival periods exceeding 5 Years of malignant tumors; 3. The result of any one of the following virological tests is positive: HIV; HCV; HBsAg; HBcAb positive, and HBV DNA copy number is positive at the same time; TPPA; 4. Live vaccines have been vaccinated within 28 days before enrollment; 5. Received autologous stem cell transplantation within 45 days before enrollment, and received allogeneic hematopoietic stem cell transplantation in the past; 6. The investigator judges that there are comorbidities that require the use of systemic corticosteroid therapy or other immunosuppressive drugs during the study period; 7. Received CNS directional radiotherapy within 28 days before enrollment; 8. Acute side effects caused by previous treatment have not recovered to Grade 1 or below (except for hematological toxicity and hair loss); 9. Known to have life-threatening hypersensitivity or other intolerances or severe allergies to cyclophosphamide or fludarabine; 10. Active autoimmune diseases (including but not limited to systemic lupus erythematosus, Sjogrens syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimotos thyroiditis, etc., except only through hormone replacement Treatment of controllable hypothyroidism); 11. Received major surgery under general anesthesia within 28 days before enrollment, or failed to recover from previous surgical treatments and achieved clinical stability, or expected major surgery under general anesthesia during the study; 12. Used other clinical research drugs within 28 days before enrollment; 13. Suffered from any unstable circulatory system disease within 180 days before enrollment, including but not limited to unstable angina, myocardial infarction, heart failure [New York Heart Association (NYHA) grade >= grade iii], serious medical treatment Arrhythmia, or cardiovascular angioplasty, coronary stent implantation or heart bypass surgery within 180 days before enrollment; 14. There is a history or disease of the central nervous system, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 15. Uncontrollable active infection (such as sepsis, bacteremia, fungemia, viremia) during screening; 16. Other situations that the investigator believes are not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limiting toxicity;laboratory examination;vital signs;physical examination; replication competent lentivirus; | — |
Secondary
| Measure | Time frame |
|---|---|
| cytokines in peripheral blood;overall survival;progression-free survival;duration of response; | — |
Countries
China
Contacts
Public ContactZhang Yi
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed