Last updated on May 2019

Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT


Brief description of study

Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with high risk multiple myeloma after auto-HSCT.To test the safety and efficacy of giving targeting CD19 or B-cell maturation antigen T cells in treating patients with CD19 or BCMA positive high risk multiple myeloma followed with auto-HSCT.

Detailed Study Description

Adults ages 18-75 with high risk Multiple Myelomas (not achieved VGPR before stem cell mobilization or R-ISS III stage or with extramedullary infiltration or with del(17p), t(4;14), t(14;16)).

Design

Participants may be screened with:

Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Participants will have apheresis. Blood is removed through a needle in an arm. T cells are removed. The rest of the blood is returned through a needle in the other arm.

The cells will be changed in a laboratory. Participants will get auto-HSCT. 14 and 20 days after auto-HSCT, participants will get the T cells through the IV in 1 infusion.

After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.

Participants will visit the clinic 1, 2, 3, 4, 6, and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 2-month visit.

Clinical Study Identifier: NCT03455972

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Recruitment Status: Open


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