Trial | NCT02963038  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cd19 car-t cells ...

  • Study Participants

    10
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.
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.
Study Started
Jun 30
2016
Primary Completion
Jun 30
2017
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Apr 28
2017

Biological Autologous CD19-targeting CAR T cells

Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.

CD19 CAR T cells Experimental

Autologous CD19-targeting CAR T cells

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.
No Results Posted