Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

Launched by KECELLITICS BIOTECH COMPANY LTD · Dec 6, 2022

Keywords

ClinConnect Summary

Although the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. There are some patients who resisted anti-CD19 CAR-T cells or get CD19 negative relapse. To make further improvement, We launch such a clinical trial using sequential CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Lymphoma to evaluate the efficacy and safety of sequential CD19 and CD22 targeted CAR-T cell therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Relapsed or refractory B cell non-hodgkin lymphoma.
• • 2. KPS\>60.
• • 3. Life expectancy\>12 weeks.
• • 4. Gender unlimited, age from 3 years to 70 years.
• • 5. Evidence for cell membrane CD19 and/or CD22 expression;
• • 6. Patients who have failed at least one line of a standard treatment.
• • 7. No serious mental disorder.
• • 8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
• • 9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
• • 10. No other tumors.
• • 11. Patients volunteer to participate in the research.
• • 12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial
• Exclusion Criteria:
• • 1. Pregnancy and nursing females.
• • 2. Patients are allergic to cytokines.
• • 3. Uncontrolled active infection.
• • 4. Acute or chronic GVHD.
• • 5. Treated with T cell inhibitor.
• • 6. Patients who had used steroid hormones within one week.
• • 7. Patients who had used Rituximab within two weeks.
• • 8. HIV/HBV/HCV Infection.
• • 9. Other situations we think improper for the research.

Trial Officials