Lymphoma, B-Cell Clinical Trial
Official title:
Phase 1/Phase 2 Study of Sequential Chimeric Antigen Receptor T Cell Targeting at CD19 and CD22 B-cell Antigens Treating Refractory or Relapsed B-cell Lymphoma Patients
This is a single arm study to evaluate the efficacy and safety of Sequential CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Lymphoma.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 10, 2025 |
Est. primary completion date | December 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Hebei Yanda Ludaopei Hospital | Langfang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Kecellitics Biotech Company Ltd | Hebei Yanda Ludaopei Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events that related to treatment | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). | 1 years | |
Primary | Overall remission rate (ORR) | The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria. | 3 months | |
Secondary | complete response(CR) | The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria. | 24 months | |
Secondary | partial response(PR) | The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria. | 24 months | |
Secondary | stable disease(SD) | The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria. | 24 months | |
Secondary | progressive disease(PD) | The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria. | 24 months | |
Secondary | Duration of remission (DOR) | DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause. | 24 months |
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