A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: OlyCAR-019 Cell Infusion OlyCAR-019 cell infusion will be administered by vein after short-time manufacture. |
Biological: Anti-CD19 Autologous CAR-T Cell Infusion
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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A definite diagnosis of relapsed/refractory B-cell malignancies;
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Male or female, aged 2-75 years;
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Confirmed detectable disease;
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Expected survival time >12 weeks;
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Eastern cooperative oncology group (ECOG) score is 0-2;
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Adequate liver , kidney and cardiopulmonary function;
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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;
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Willingness to complete the informed consent process and to comply with study procedures and visit schedule.
Key Exclusion Criteria:
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Presence of other concurrent active malignancy; People with severe mental disorders;
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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;
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Acute GVHD of grade II-IV or extensive chronic GVHD;
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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;
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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;
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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;
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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);
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Had undergone other clinical trials in the 4 weeks prior to participating in this trial;
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Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan;
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For patients contraindicated with cyclophosphamide and fludarabine chemotherapy;
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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;
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Receiving donor lymphocyte infusion within 6 weeks before enrollment;
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Pregnant and lactating women;
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Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | Kunming | Yunnan | China | 650100 |
Sponsors and Collaborators
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Investigators
- Principal Investigator: Sanbin Wang, Professor, 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KM-PBC920