Novel Anti-CD19 Universal CAR-T Cells for r/r CD19+ B-ALL

Launched by 920TH HOSPITAL OF JOINT LOGISTICS SUPPORT FORCE OF PEOPLE'S LIBERATION ARMY OF CHINA · Nov 25, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called UCAR-T cells for patients with a specific kind of blood cancer known as relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). This trial aims to find out how safe and effective this treatment is. It is open to anyone aged 2 to 75 who has been diagnosed with B-ALL that has not responded to previous treatments and has certain signs in their blood or bone marrow.

Participants in the trial can expect to receive an injection of the UCAR-T cells and will be monitored closely for any side effects and how well the treatment works. However, there are some important eligibility criteria to consider: patients should not have other active cancers, severe mental health issues, or specific health problems affecting their heart or lungs. Women must also have a negative pregnancy test and agree to use birth control during the study. Overall, this trial is looking for volunteers who are ready to explore a potential new treatment option for their leukemia.

Gender

ALL

Eligibility criteria

• 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 UCAR-T 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.

Trial Officials