B-Cell Lymphoma Clinical Trial
Official title:
An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events(AE) after infusion | The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. | Up to 12 months after infusion | |
Primary | MTD | MTD will be determined based on DLTs observed during the first 28 days of study treatment. | Up to 28 days after infusion | |
Secondary | Overall Response Rate (ORR) | Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR). | Up to 3 months after infusion | |
Secondary | Progression-free survival(PFS) | Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause. | Up to 3 months after infusion |
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