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

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

Inclusion criteria

• The patient volunteered to participate in the study, and signed the Informed Consent
• Age 18-75 years old, male or female
• Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
• r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
• At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
• Adequate organ and bone marrow fuction
• No contraindications of apheresis
• Expected survival time > 3 months
• ECOG scores 0 - 1

Exclusion criteria

• Have a history of allergy to cellular products
• Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
• A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
• Patients with active CNS involvement
• Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors
• Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
• Live vaccination within 4 weeks before peripheral blood apheresis
• HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
• Have a history of alcoholism, drug addiction and mental illness
• Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
• Patients with severe fludarabine or cyclophosphamide hypersensitivity
• The patient has a history of other primary cancers, except for the following:

• Non-melanoma such as skin basal cell carcinoma cured by resection
• Cured carcinoma in situ such as cervical, bladder or breast cancer
• The investigators believe that there are other circumstances that are not suitable for the trial