To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects Wi… (NCT06045091) | Clinical Trial Compass
RecruitingEarly Phase 1
To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
China18 participantsStarted 2023-07-04
Plain-language summary
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
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
. Serum M protein: IgG M protein ≥5 g/L; or IgA M protein ≥5 g/L; or IgD M protein and IgD \>ULN;
. Urine M protein ≥200 mg/24h;
. Affected serum free light chain ≥100 mg/L and Serum free light chain ratio is abnormal;
. Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;
. Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;
. Progress is documented within 60 days of the most recent anti-tumor treatment, or efficacy assessment does not reach minimal response(MR) or above;
. Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min;
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.
1Since this is an early Phase 1 trial primarily designed to find a safe dose of this CAR-NK cell therapy, what does that mean for what we'd know — and not know — about whether it's actually working against my myeloma or plasma cell leukemia?
2This trial is testing a new type of immune cell therapy that targets BCMA — how does using NK cells instead of the more common T cells affect the expected side effects or risks, and are there any early safety signals I should be aware of?
3Given that dose-limiting toxicity is what's being measured, how would my doctors monitor me for serious reactions, and what would happen if I experienced one during the study?
4I have relapsed or refractory disease, which means other treatments haven't worked — before considering this experimental trial, are there any standard or approved BCMA-targeted options, like other CAR-T therapies or bispecific antibodies, that we haven't tried yet?
5What would the treatment schedule and monitoring visits actually look like day-to-day, and is this something that's realistic given where I live and my current health 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.