Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r… (NCT07085559) | Clinical Trial Compass
RecruitingEarly Phase 1
Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
China36 participantsStarted 2025-06-23
Plain-language summary
A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.
Who can participate
Age range
19 Years – 75 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
. Complete blood count (CBC) test \[the following criteria should be met within 24 hours prior to apheresis, and supportive treatment such as transfusion, platelet transfusion, cell growth factor (except recombinant erythropoietin) should be avoided within 7 days prior to detection\]: Absolute neutrophil count (ANC) ≥1×10\^9 /L; hemoglobin ≥70 g/L.; platelets ≥50×10\^9 /L; absolute lymphocyte count (ALC) ≥0.3×10\^9 /L;
. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×upper limit of normal (ULN); total serum bilirubin ≤ 1.5×ULN.
. Kidney function: Serum creatinine ≤2.5×upper limit of normal (ULN), or； Creatinine clearance rate (CrCl) calculated according to Cockcroft-Gault formula ≥ 60 ml/min.
. Coagulation function: Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time (APTT) ≤ ULN+10s, prothrombin time (PT) ≤ ULN+3s.
. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%.
. The proportion of primitive naive or monoclonal plasma cells ≥ 5% by bone marrow cytology, bone marrow biopsy histology or flow cytometry;
. Serum monoclonal protein (M-protein) level: M protein ≥10 g/L for IgG type, M protein ≥5g/L for IgA, IgD, IgM, and IgE type;
Exclusion criteria
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 a safe dose and tracking side effects of a new 'metabolically armed' CAR-T cell therapy — what does that mean for what's actually known right now about whether it works, and is it too early in testing for someone in my situation?
2CAR-T cell therapies can cause serious side effects like cytokine release syndrome — given that this trial is specifically measuring adverse events and maximum tolerated dose, what kinds of risks should I be prepared for with this particular experimental version?
3My diagnosis is one of three conditions this trial covers — multiple myeloma, plasma cell leukemia, or AL amyloidosis — does my specific diagnosis make me a better or worse fit for this trial compared to the others being studied?
4Are there standard BCMA-targeted treatments, like approved CAR-T therapies or bispecific antibodies, that I should consider trying first before enrolling in an early-phase experimental study like this one?
5What would my care and monitoring schedule look like if I joined this trial — for example, how long would I need to be near the treatment center, and what level of follow-up is typically required after a CAR-T infusion in a Phase 1 setting?
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
MTD
Timeframe: MTD will be determined based on DLTs observed during the first 35 days of study treatment.
. Any hematopoietic stem cell transplant(HSCT) within 2 months prior to the start of infusion of Meta10-BCMA, or any immunosuppressive therapy due to graft-versus-host disease after HSCT within the screening period;
. Any major surgery within 4 weeks prior to screening;
. Any radiotherapy 2 weeks prior to screening;
. Any intrathecal treatment within 1 week prior to the start of infusion of Meta10-BCMA;
. Any live vaccination within 4 weeks prior to the start of infusion of Meta10-BCMA and/or plan to receive live vaccines after participation in the trial;
. Any clinical trial therapy within 4 weeks prior to the start of infusion of Meta10-BCMA, or ongoing participation in other clinical trials.
. ≥ grade 2 arrhythmia according to NCI CTCAE 5.0 grade or QTc\> 450 ms (male), QTc\> 470ms (female) (QTc is calculated using Fridericia correction formula QTc = QT / RR0.33) subjects with a history of Torsades de pointes ventricular tachycardia or congenital prolonged QT syndrome;
. Subjects with any of the following diseases within 12 months before the screening: including but not limited to unstable angina pectoris, myocardial infarction, congestive heart failure and severe arrhythmia, coronary artery bypass grafting or peripheral artery bypass grafting surgery, cerebrovascular events (including transient ischemic attacks), etc.;