A Study of MCARH109 and MCARH125 in People With Multiple Myeloma (NCT05431608) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of MCARH109 and MCARH125 in People With Multiple Myeloma
United States15 participantsStarted 2022-06-20
Plain-language summary
A sample of participants' T cells will be sent to a laboratory, where the cells will be made into the study therapy, MCARH109 and MCARH125. Participants will receive either MCARH125 alone or MCARH125 with MCARH109.
Who can participate
Age range
18 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
. A proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib)
. An immunomodulatory drug (e.g., thalidomide, lenalidomide, pomalidomide)
. A CD38 monoclonal antibody (e.g., daratumumab)
. High dose chemotherapy with autologous stem cell support (ASCT)
. Serum M protein ≥ 0.5 g/dL
. Involved serum free light chain ≥10 mg/dL with an abnormal free light chain ratio
. Urine M-protein ≥ 200 mg/24 hours
. Measurable plasmacytomas seen on imaging (≥ 1 lesion that has a single diameter ≥ 2 cm). If this is the primary marker of measurable disease, patients will need a biopsy at the pre-treatment screening (screening B).
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.
1This is a Phase 1 trial focused on finding safe doses of these two CAR-T cell therapies — what does that mean for what's actually known about whether they work, and how does that weigh against other options I might have right now?
2Since the trial is no longer actively recruiting, is there any chance I could still be considered for enrollment, or should we focus on finding other studies or treatments that are currently open?
3This trial targets people with relapsed or refractory multiple myeloma — given where I am in my treatment history, would my doctor think this kind of approach is appropriate for my specific situation?
4MCARH109 and MCARH125 are two separate CAR-T cell therapies being tested together — can my doctor explain what that combination targets in myeloma and what early safety signals, if any, have come out of this type of approach?
5CAR-T cell therapy can involve serious side effects like cytokine release syndrome — what kind of monitoring, hospital stays, or recovery time would typically be involved in a trial like this, and how might that fit with my current health and life situation?
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/MTS of MCARH109 and MCARH125 T cells