TriPRIL CAR T Cells in Multiple Myeloma (NCT05020444) | Clinical Trial Compass
Active — Not RecruitingPhase 1
TriPRIL CAR T Cells in Multiple Myeloma
United States16 participantsStarted 2021-10-05
Plain-language summary
This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.
This research study involves the study drugs:.
* TriPRIL CAR T Cells
* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process
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:
* Ability to understand and the willingness to sign a written informed consent document.
* Age ≥18 years at the time of signing informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy of greater than 12 weeks
* Histologically or cytologically confirmed diagnosis of relapsed/refractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:
* Serum M-protein ≥1.0 g/dL
* Urine M-protein ≥200 mg/24 hours
* Involved serum free light chain ≥100 mg/L with abnormal κ/λ ratio
* Bone marrow plasma cells ≥30%
* Relapsed/refractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has "triple-refractory" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.
Note: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.
* Adequate organ and marrow function as defined below:
* O2 saturation ≥92% on room air while awake
* LVEF ≥40% by ECHO or MUGA scan
* ANC ≥1.0k/μl, PLT ≥50k/μl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)
* Cre…
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
Incidence of adverse events (AEs)
Timeframe: Week 24 post dosing, and every three months until two years.
2
Incidence of Dose Limiting Toxicity (DLT)
Timeframe: Week 24 post dosing, and every three months until two years.