Eligibility |
Inclusion Criteria:
- 1. Volunteered to participate in this study and signed informed consent
- 2. Age 18-75 years old, male or female
- 3. CD19 or CD20 positive DLBCL (including PMBCL and tFL), FL and MCL confirmed by
cytology or histology according to WHO2016 criteria. For CD20-positive subjects, they
should have received at least one regimen containing anti-CD20-targeted therapy (such
as rituximab). If they do not complete the regimen due to intolerance, the cause
should be recorded.
- 4. Relapsed or refractory disease after = 2 lines (for FL, at least 3 lines) of
standard therapy or relapsed after autologous stem cell transplantation (ASCT)
- 5. At least one measurable lesion (LDi = 1.5 cm);
- 6. At least two weeks from last treatment (radiation, chemotherapy, mAb, etc) to
apheresis;
- 7. LVEF= 50% (ECHO)
- 8. No active pulmonary infections, normal or mild impaired pulmonary function and
SpO2=92%
- 9. Laboratory criteria: ANC=1.0×109/L; Platelets=50×109/L; Serum total bilirubin =1.5x
ULN; Creatinine= ULN; AST and ALT=3x ULN
- 10. No contraindications of apheresis;
- 11. Expected survival = 3months
- 12. ECOG score 0 or 1
Exclusion Criteria:
- 1. Have a history of allergy to cellular products;
- 2. According to the NYHA cardiac function grading standards, patients with grade III
or IV cardiac dysfunction;
- 3. A history of craniocerebral trauma, disturbance of consciousness, epilepsy,
cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
- 4. Patients with central nervous system involvement;
- 5. Patients with autoimmune diseases, immunodeficiency or other conditions requiring
immunosuppressive therapy;
- 6. Received allogeneic hematopoietic stem cell transplantation before;
- 7. Previous use of any CAR T cell product or other genetically modified T cell
therapy;
- 8. Autologous stem cell transplantation within 6 weeks before infusion;
- 9. Severe active infections (except for simple urinary tract infections, bacterial
pharyngitis), or currently undergoing intravenous infusion of antibiotics. However,
prophylactic antibiotic, antiviral and antifungal infection treatments are
permissible;
- 10. Live vaccination within 4 weeks prior to apheresis;
- 11. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
- 12. A history of alcohol abuse, drug use or mental illness;
- 13. Subjects who are not sterilized and have any of the following conditions:
1. are pregnant/lactating; or
2. planned pregnancy during the trial; or
3. being fertile and unable to use effective contraception;
- 14. Severe hypersensitivity to fludarabine or cyclophosphamide;
- 15. A history of other primary cancers other than the following:
1. Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by
excision
2. Cured in situ cancers such as cervical, bladder, or breast cancer
- 16. The investigators consider that the subject has other conditions that are not
suitable for this trial.
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