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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Collaborator: Shanghai Celluar Biopharmaceutical Group Ltd.

Criteria

Inclusion Criteria:

• The patient volunteered to participate in the study, and signed the Informed Consent;

• Age 18-75 years old, male or female;

• Subjects diagnosed with diffuse large B-cell lymphoma (DLBCL) histologically according to the 2016 edition of the WHO Lymphocytic Tumor Classification Standard;

• At least one measurable lesion(LDi≥ 1.5 cm);

• r/r patients who received prior CD19 CAR-T therapy, and the CD19 CAR-T cell therapy must be at least 3 months from the screening period and positive for CD20;

• At least 2 weeks from the end of treatment regimen (radiation, chemotherapy, mAb, etc) to apheresis;

• Echocardiography showed normal diastolic function, left ventricular ejection fraction (LVEF) ≥50%, no Pericardial effusion and no severe arrhythmia;

• No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air.

• NEUT ≥ 1.0 × 10^9 / L, PLT ≥ 50 × 10^9 / L, TBIL ≤ 1.5 times the upper limit of the normal range, Cr ≤ the upper limit of the normal range, ALT, AST ≤ 3 times the upper limit of the normal range;

• No contraindications of peripheral blood apheresis;

• Expected survival time > 3 months;.

• ECOG scores 0 - 1;

• The apheresis was received by laboratory and met the requirements for manufacturing CAR-T cell.

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

• After allogeneic hematopoietic stem cell transplantation;

• Autologous stem cell transplantation within 6 weeks before cell therapy;

• 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.