Trial | NCT03881761  Report issue

Title

CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
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.
Study Started
Feb 01
2019
Primary Completion
Jan 31
2021
Anticipated
Study Completion
Jan 31
2022
Anticipated
Last Update
Mar 21
2019

Biological CD19/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

experimental arm Experimental

CAR-T cell group

Criteria 

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
No Results Posted