Trial | NCT02782351  Report issue

Title

Humanized CAR-T Therapy for Treatment of B Cell Malignancy
Humanized CAR-T Therapy for Treatment of Recurrent or Refractory B Cell Malignancy by Targeting CD19

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.
Study Started
May 31
2016
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Aug 04
2017

Biological CAR-T

Patients will be infused with autologous CAR-T infusion in a dose escalating manner.

CAR-T Experimental

In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.

Criteria 

Inclusion Criteria:

Age≥3 at the time of consent
Survival time>12 weeks
B cell hematological malignancies by pathological examination
Chemotherapy failure or recurrent B cell malignancy
Creatinine< 2.5mg/dl
Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
Karnofsky Performance Status>50% at the time of screening
Bilirubin<2.0mg/dl
Adequate pulmonary, renal, hepatic, and cardiac function
Fail in autologous or allogenic haemopoietic stem cell transplantation
Free of leukocytes removal contraindications

Exclusion Criteria:

Pregnant or nursing women
Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
Previous treatment with any gene therapy product
Abnormal vital signs
Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
General infection or local severe infection, or other infection that is not controlled
Dysfunction in lung, heart, kidney and brain.
Severe autoimmune diseases
other symptoms that are not applicable for CAR-T
No Results Posted