A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

This is an interventional treatment trial for B Cell Lymphoma focused on measuring B cell lymphoma received prior CD19 CAR-T therapy Read More

Inclusion Criteria:

1. Volunteered to participate in this study and signed informed consent
2. Age 14-70 years old, male or female
3. Patients with CD20+ DLBCL(including PMBL and according to the NCCN. non Hodgkin's lymphoma Guidelines(2019 version1.0) , at least one measurable lesion(LDi≥ 1.5 cm);
4. r/r patients who received prior CD19 CAR-T therapy；
5. At least one week from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;
6. No immunosuppressive therapy was used within 1 week before infusion, including but not limited to systemic therapy;
7. No mAb treatment within 2 weeks before infusion
8. LVEF≥ 50% (UCG)
9. No active pulmonary infections, normal pulmonary function and SpO2≥92%
10. No contraindications of apheresis;
11. Expected survival ≥ 3months
12. ECOG score 0 or 1
13. The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell

Exclusion Criteria:

1. Have a history of allergy to cellular products
2. Laboratory criteria: Serum total bilirubin ≥2mg/dl, albumin≤35g/L, AST and ALT ≥5 x ULN, Creatinine≥2.0mg/dl, ANC≤750/uL, Platelets≤ 50x10^9/L
3. Have a hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome ,etc;
4. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction；
5. A history of QT prolongation
6. Patients with central nervous system involvement
7. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics, or intravenous infusion of antibiotics within 1 week prior to cell infusion. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
8. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;

9. Subjects who are not sterilized 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；
10. The investigators consider that the subject has other conditions that are not suitable for this trial.