B-cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
An Investigator-initiated Trial to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of Relapsed/Refractory(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia(B-ALL)
Verified date | November 2022 |
Source | Kunming Hope of Health Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm, single-center, open-labeled clinical study to evaluate the safety and efficacy of LstCAR019 injection for patients with relapsed/refractory(r/r) B-cell Acute Lymphoblastic Leukemia(B-ALL).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Male or female, aged 2-75 years; 2. A definite diagnosis of relapsed/refractory B-ALL and a percentage of primitive/naive lymphocytes >5% in bone marrow at baseline (flow cytometry); 3. CD19 expression was positive in bone marrow or peripheral blood tumor cells; 4. ECOG score 0-2 points; 5. Expected survival time =3 months; 6. Adequate liver, kidney, heart and lung function; 7. Patients who have recovered from acute toxic effects of prior chemotherapy should be excluded from the trial at least one week apart; 8. 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; 9. Voluntarily sign the informed consent. Exclusion Criteria: 1. Presence of other concurrent active malignancy; 2. People with severe mental disorders; 3. A 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; 4. Acute GVHD of grade II-IV or extensive chronic GVHD; 5. Had 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; 6. 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; 7. A history or disease of the central nervous system(CNS), such as seizure disease, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 8. 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; 9. Patients with severe history of allergy or allergic constitution; 10. 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; 11. Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); 12. Had undergone other clinical trials in the 4 weeks prior to participating in this trial; 13. Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; 14. For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; 15. Subjects requiring systemic corticosteroid therapy (prednisone =5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after LstCAR019 cell reinfusion, except for adverse events; 16. Receiving donor lymphocyte infusion within 6 weeks before enrollment; 17. Pregnant and lactating women; 18. Any other condition that the investigator deemed inappropriate for inclusion. |
Country | Name | City | State |
---|---|---|---|
China | Kunming Hope of Health Hospital | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Kunming Hope of Health Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose-limiting toxicity (DLT) | Neurotoxicity and/or CRS=G3. | Up to 28 days after LstCAR019 infusion | |
Primary | Incidence of Treatment Related adverse events (AEs) | The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included. | Up to 12 months after LstCAR019 infusion | |
Secondary | Persistence of CAR-T cells | The persistence over time of CAR-T cells in the peripheral blood as determined by flow cytometry and qPCR. | Up to 24 weeks after infusion | |
Secondary | Objective response rate (ORR) | Patients who achieve CR(complete response) or CRi after infusion | At 4 ,8 , 12 weeks after infusion | |
Secondary | Progression-free survival (PFS) | Progression-free survival (PFS) is the time between the time a patient with tumor disease receives treatment and the time between the observation of disease progression or death from any cause. | Up to 24 weeks after infusion | |
Secondary | Overall survival (OS) | Overall survival (OS) is the time from randomization to death from any cause. | Up to 24 weeks after infusion | |
Secondary | Duration of remission (DOR) | Duration of remission (DOR) is the time from the first detection of CR or PR to the discovery of PD. | Up to 24 weeks after infusion |
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