T-cells Expressing an Anti-SLAMF7 CAR for Treating Multiple Myeloma
Status:
Completed
Trial end date:
2021-01-19
Target enrollment:
Participant gender:
Summary
Background:
Multiple myeloma is a blood cancer that is usually incurable. T cells are part of the immune
system. Researchers think changing a person's T cells to recognize their cancer could help
the person's body kill tumor cells. This is a new approach that uses a patient's own cells to
target multiple myeloma.
Objective:
To see if giving anti-Signaling lymphocytic activation molecule F7 (SLAM7) chimeric antigen
receptor (CAR) T cells with a stop switch to people with multiple myeloma is safe and to see
if adding a gene to stop T-cell activity can limit toxicity of this therapy.
Eligibility:
People ages 18-73 with multiple myeloma for which prior standard treatment has not worked
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Blood, urine, and heart tests
- Bone marrow samples: A needle inserted into the participant's bone will remove marrow.
- Imaging scans: Participants will lie in a machine that takes pictures of the body.
Participants will have apheresis. They will receive a catheter or central line: A plastic
tube will be inserted into a chest or arm vein. Blood will be removed and the T cells
separated. The rest of the blood will be returned to the participant. The T cells will be
manipulated in the lab.
Participants will get chemotherapy through the central line for 3 days.
Participants will receive the manipulated T cells through the central line. They will stay in
the hospital at least 9 days.
Participants will have follow-up visits 2 weeks then 1, 2, 3, 4, 6, 9, and 12 months after
the infusion. They will then have visits every 6 months for 3 years. Then they will be
contacted once per year for 15 years. All visits will include blood tests, and 3 visits will
include bone marrow biopsies....