Safety and Efficacy of Sequential CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: arm 1 sequential CD19 and CD22 targeted CAR-T cells treat |
Biological: CD19 and CD22 targeted CAR-T cells
CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (300 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given.(anti-CD19 CAR-T first, then anti-CD22 CAR-T).
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Outcome Measures
Primary Outcome Measures
- Adverse events that related to treatment [1 years]
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).
- Overall remission rate (ORR) [3 months]
The ORR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
Secondary Outcome Measures
- complete response(CR) [24 months]
The CR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
- partial response(PR) [24 months]
The PR of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
- stable disease(SD) [24 months]
The SD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
- progressive disease(PD) [24 months]
The PD of Sequential CD19 and CD22 CAR-T treatment will be recorded and assessed according to the revised 2014 Lugano Criteria.
- Duration of remission (DOR) [24 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Relapsed or refractory B cell non-hodgkin lymphoma.
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KPS>60.
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Life expectancy>12 weeks.
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Gender unlimited, age from 3 years to 70 years.
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Evidence for cell membrane CD19 and/or CD22 expression;
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Patients who have failed at least one line of a standard treatment.
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No serious mental disorder.
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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).
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No other serious diseases(autoimmune disease, immunodeficiency etc.).
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No other tumors.
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Patients volunteer to participate in the research.
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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:
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Pregnancy and nursing females.
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Patients are allergic to cytokines.
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Uncontrolled active infection.
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Acute or chronic GVHD.
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Treated with T cell inhibitor.
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Patients who had used steroid hormones within one week.
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Patients who had used Rituximab within two weeks.
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HIV/HBV/HCV Infection.
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Other situations we think improper for the research.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hebei Yanda Ludaopei Hospital | Langfang | Hebei | China | 065201 |
Sponsors and Collaborators
- Kecellitics Biotech Company Ltd
- Hebei Yanda Ludaopei Hospital
Investigators
- Study Chair: li xiangqun, doctor, Kecellitics Biotech Company Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Kece-4