Relapsed or Refractory B-cell lymphoma
Conditions
Interventions
low dose grop:3-5×10^6 CAR T cells/Kg
intermediate dose grop:6-8×10^6 CAR T cells/Kg
high dose grop:9-10×10^6 CAR T cells/Kg
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (All of the following options must be met) (1) Signed informed consent; (2) male and female aged 18-75 years; (3) Providing tumor tissue wax block or pathological biopsy slice or approving to have tumor tissue biopsy during screening; (4) At least one measurable lesion (lugano, 2014) (5) Relapsed or Refractory B-cell lymphoma include: iNHL(Disease typeFLlMZ) LInvasive B cell lymphoma (Disease type DLBCLPMBCLTFL and TCRBCL); (6) Refractory subgroup (primary refractory (refractory to first line therapy or relapsed within 1 year after first line therapy); Refractory to 2nd or greater line therapyincluding chemotherapy combined with anti-CD20 antibody treatment in therapy regimensRelapsed within 1 year after autologous hematopoietic stem cell transplantation; (7) Unconditional acceptance of hematopoietic stem cell transplantation; (8) Predictions of survival>3 months; (9) Performance status ECOG =1; (10) Ventricular ejection fraction=50%no obvious abnormality in ECG; SaO2 >90%; ALT or AST=2.5 times ULNTBil=1.5 times ULN; (11) Hgb=80g/L,WBC=2×10^9/L, ANC=1×10^9/L, PLT=50×10^9/L; (12) Fertile females/males must consent to use contraceptives during participation of the trial; (13) Normal communication and Compliance with hospital management; (14) Comply with clinical trial requirements.
Exclusion criteria
Exclusion criteria: (1) Allergy to MBC19 or any of MBC19; (2) Immunosuppressant or hormone therapy within 7 days before PBMC collection, or Symptomatic autoimmune diseases; asthma complete remission without intervention; (3) Inoculated anti-tumor vaccine, or anti-neoplastic drug therapist with immunostimulant within 4 weeks before signing informed consentor anti-infective vaccine; (4) Meningeal transfer or Symptomatic central nervous system metastasis; (5) Prior CART therapy regimens or Participation in clinicaltrial within 3 months before signing informed consent; (6) Prior autologous hematopoietic stem cell transplantation; (7) Small lymphocytic lymphomaSLL; (8) Known human immunodeficiency virus infectionor Acquired/Congenital immunodeficiency disease, or organ transplantation; (9) Uncontrollable infection or Require intravenous treatment; Active infectious disease, HIV antibody positive or Syphilis antibody positive; (10) Prior active tuberculosis infection within 1 year before signing informed consent; (11) Prior Interstitial lung disease or non-infectious pneumonia(except for radiation therapy); (12) Active central nervous system disease; (13) Hypoxemia; (14) Unexplained fever > 38.5 degree C during screening or before the first administration (except for tumorous fever); (15) Prior ChemotherapyRadiotherapyMolecular targeted therapy or Major surgery within 1 year before signing informed consent, and TEAE had been not returned to baseline or =Grade 1; (16) Prior Cardiovascular events, or myocardial infarctionCardiocerebral syndromeSevere arrhythmiaUnstable angina pectoris or Poorly controlled arrhythmias or hypertension within 6 months before enrollment; (17) Prior other malignant tumors; (18) Pregnancy or lactation; (19) History of alcohol abuse or drug use; (20) Poor compliance due to mental reasons; (21) Unsuitable for inclusion, as judged by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicity,DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics parameters;MTD;cytokine level;Efficacy established on the basis of anti-tumor;adverse event;RP2D; | — |
Countries
China
Contacts
Public ContactTing Liu
West China Hospital, Sichuan University
Outcome results
None listed