B-Cell Lymphoma Stage I, Refractory, Relapsed
Conditions
Brief summary
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Detailed description
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
Interventions
BIOLOGICALCD19/CD20 bispecific CAR-T cells
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Sponsors
Henan Hualong Biotechnology Company
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Eligibility
Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* expected lifetime\>3 months * CD19/CD20 positive relapsed/refractory B cell lymphoma * KPS\>70 * at least one measurable lesion according to RECIST 1.1 * enough function of hear, liver, kidney and bone marrow * no history of severe allergies * no other history of malignancy * no other diseases that conflict with this regimen * no serious mental illness * patient or family member sign informed consent
Exclusion criteria
* Pregnant or lactating women * Severe infectious or viral disease * Active B or C viral hepatitis * Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks * participated in other clinical studies in the last 3 months, or have been treated with other gene products * Others not appropriate to participate in this study examined by the investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of study related adverse events | one year | safety of CAR-T cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | three months | proportion of patients with complete response and partial response |
| survival time of CAR-T cells in vivo | one year | from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo |
| progression-free survival | one year | the enrollment to the first time that disease progression is detected |
Countries
China
Contacts
Primary ContactYongping Song, Dr.
Backup ContactQuanli Gao, Dr.
Outcome results
None listed