Lymphoma, B-Cell
Conditions
Keywords
CAR-T, Lymphoma
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.
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.
Interventions
BIOLOGICALCD19 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).
Sponsors
Hebei Yanda Ludaopei Hospital
Kecellitics Biotech Company Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary Contactli xiangqun, doctor
Outcome results
None listed