Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy

Hebei Senlang Biotechnology Inc., Ltd.1 site in 1 country10 target enrollmentJune 2016

ConditionsB-Cell Leukemia B-Cell Lymphoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: B-Cell Leukemia
Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Enrollment: 10
Locations: 1
Primary Endpoint: Tumor load
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

Detailed Description

The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 2021

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hebei Senlang Biotechnology Inc., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The treat history meeting the following criteria:
•Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
•Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
•One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
•There is a measurable lesions before treatment at least;
•ECOG score≤2;
•To be aged 1 to 70 years;
•More than a month lifetime from the consent signing date

Exclusion Criteria

•Serious cardiac insufficiency, left ventricular ejection fraction\<50;
•Has a history of severe pulmonary function damaging;
•Merging other malignant tumor;
•Merging uncontrolled infection;
•Merging the metabolic diseases (except diabetes);
•Merging severe autoimmune diseases or immunodeficiency disease;
•patients with active hepatitis B or hepatitis C;
•patients with HIV infection;
•Has a history of serious allergies on Biological products (including antibiotics);
•Happened in 3 \~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.