T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma (NCT03602612) | Clinical Trial Compass
CompletedPhase 1
T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma
United States35 participantsStarted 2018-09-14
Plain-language 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.
Who can participate
Age range
18 Years – 73 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
Multiple Myeloma (MM) criteria:
* B Cell Maturation Antigen (BCMA) expression must be detected on malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry. If patient has plasmacytomas, one plasmacytoma must be biopsied to demonstrate BCMA expression. A specific quantitative level of BCMA expression for eligibility is not specified, but patients with multiple myeloma cells that are negative for BCMA by flow cytometry and immunohistochemistry on either bone marrow biopsy or plasmacytoma biopsy will not be enrolled. These assays must be performed at the National Institutes of Health (NIH). It is not required that the specimen used for BCMA determination comes from a sample that was obtained after the patients most recent treatment. If paraffin embedded unstained samples of bone marrow involved with MM or a plasmacytoma are available, these can be shipped to the NIH for BCMA staining, otherwise new biopsies will need to be performed for determination of BCMA expression.
* BCMA expression will need to be documented on the majority of malignant plasma cells by flow cytometry at the NIH at some time after the original anti-BCMA chimeric antigen receptors (CARs) T-cell infusion in all patients undergoing a second anti-BCMA CAR T-cell infusion.
* Bone marrow plasma cells must make up less than 50% of total bone marrow cells based on a bone marrow biopsy performed within 24 days of the start of protocol treatmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) of Anti-B Cell Maturation Antigen (BCMA) - Chimeric Antigen Receptor (CAR)-T Cells
Timeframe: First 28 days of treatment
2
Number of Participants at Each Dose Level Who Experience a Dose-Limiting Toxicity (DLT)