a study of novel anti-cd19 car-t in patients with r/r b-cell malignancies

Conditions: B-Cell Leukemia; B-Cell Lymphoma; B-cell Tumors

Summary: it is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-cd19 car-t manufactured by olycar platform (olycar-019) for cd19+ refractory/relapsed b-cell malignancies.

olycar is a novel car-t manufacturing system which allows to generate clinical-use car-t cells in short time. this study is going to evaluate the feasibility of car-t manufactured by olycar platform in the treatment of b-cell malignancies. the olycar-019 cells will be infused by vein. subjects will be followed for safety and efficacy up to 12 weeks. for those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.

Eligibility criteria:
key inclusion criteria: 1. a definite diagnosis of relapsed/refractory b-cell malignancies; 2. male or female, aged 2-75 years; 3. confirmed detectable disease； 4. expected survival time \>12 weeks; 5. eastern cooperative oncology group (ecog) score is 0-2; 6. adequate liver , kidney and cardiopulmonary function; 7. women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up; 8. willingness to complete the informed consent process and to comply with study procedures and visit schedule. key exclusion criteria: 1. presence of other concurrent active malignancy; people with severe mental disorders; 2. history of any of the following genetic disorders, such as fanconi anemia, schu-day syndrome, gerstmann syndrome, or any other known bone marrow failure syndrome; 3. acute gvhd of grade ii-iv or extensive chronic gvhd; 4. grade iii-iv heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; 5. the presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters; 6. human immunodeficiency virus (hiv) seropositivity; hepatitis b surface antigen positive or hepatitis b core antibody positive, and hbv-dna positive; patients with hepatitis c (hcv-rna quantitative test results positive); or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; patients with severe history of allergy or allergic constitution; 7. a history of autoimmune diseases (e.g., crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); 8. had undergone other clinical trials in the 4 weeks prior to participating in this trial; 9. poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 10. for patients contraindicated with cyclophosphamide and fludarabine chemotherapy; 11. subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after ucar-t cell reinfusion, except for adverse events; 12. receiving donor lymphocyte infusion within 6 weeks before enrollment; 13. pregnant and lactating women; 14. subjects with any other condition which the investigator considers unsuitable for inclusion in the study.

Keywords: b cell car-t cd19 leukemia lymphoma