B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
Conditions
Keywords
B Cell, CAR-T, CD19, Leukemia, Lymphoma
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALAnti-CD19 Autologous CAR-T Cell Infusion
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
Sponsors
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will receive one of the three doses of 0.5-2\*10\^6/kg, 3-4\*10\^6/kg, 5-6\*10\^6/kg.
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events(AE) after infusion | Up to 12 months after infusion | The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. |
| MTD | Up to 28 days after infusion | MTD will be determined based on DLTs observed during the first 28 days of study treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 3 months after infusion | Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR). |
| Progression-free survival(PFS) | Up to 3 months after infusion | Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause. |
Countries
China
Contacts
Primary ContactSanbin Wang, Professor
Backup ContactShiqi Li, MD
Outcome results
None listed