T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma
Status:
Active, not recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Background:
Multiple myeloma is a cancer of the blood plasma cells. It usually becomes resistant to
standard treatments. Researchers have developed a procedure called gene therapy. It uses a
person s own T cells, which are part of the immune system. The cells are changed in a lab and
then returned to the person. Researchers hope the changed T cells will be better at
recognizing and killing tumor cells.
Objective:
To test the safety of giving changed T cells to people with multiple myeloma.
Eligibility:
Adults ages 18-73 who have been diagnosed with multiple myeloma that has not been controlled
with standard therapies.
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Heart function tests
Bone marrow sample taken by needle in a hip bone
Scan of the chest, abdomen, and pelvis. They may have a brain scan.
Pregnancy test
Participants will have apheresis. Blood will be removed through an arm vein. The blood will
be separated and T cells removed. The rest of the blood will be returned through a vein in
the other arm.
Participants will have a central line placed in a large vein in the arm or chest.
Participants will get 2 chemotherapy drugs by the central line over 3 days.
Two days later, participants will get the changed T cells by the central line. They will stay
in the hospital at least 9 days.
Participants must stay near the hospital for 2 weeks.
Participants will have 8 follow-up visits over the next year for blood and urine tests. They
may have scans.
Participants blood will be collected regularly over the next several years.
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