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Multiple Myeloma (MM)Early Phase 1NCT07085559

Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research

A Early Phase 1 study testing Metabolically Armed BCMA CAR-T cells. in people with Multiple Myeloma (MM) and Plasma Cell Leukemia (PCL), run by Anhui Provincial Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Metabolically Armed BCMA CAR-T cells.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
23 Jun 2025to 15 Oct 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 19 to 75 years old, male or female. The subject or his/her guardian voluntarily signed the informed consent;
  • Subjects with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria and have had at least 3 prior lines of therapy (including chemotherapy based on proteasome inhibitors and immunomodulatory agents). Disease progression must be documented during or within 12 months following the most recent anti-myeloma treatment (for subject whose last-line treatment was CAR-T, disease progression was not limited to occurring within 12 months after treatment).
  • Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.
  • The subjects were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell transplantation, and the researchers determined that treatment was needed.
  • ECOG performance score 0-2 (except for subjects with central nervous system invasion, which needs to be confirmed by the investigator).
  • Estimated life expectancy≥12 weeks.
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  • Subjects should have adequate organ function:
  • 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.
  • Electrolytes: Serum potassium ≥ 3.0 mmol/L; Serum calcium ≥ 2.0 mmol/L; Serum magnesium ≥ 0.5 mmol/L.
  • 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 subjects must be willing to provide valid initial diagnostic evidence and undergo bone marrow examinations before and after treatment.
  • Women of childbearing age and all male patients must consent to use a effective contraception for at least 12 months after Meta10-BCMA infusion and until two consecutive PCR tests show no more CAR T cells in vivo；
  • The subjects should have measurable disease based on at least one of the following parameters:
  • 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;
  • Urine M protein level ≥200 mg/24 hours;
  • Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;
  • There are measurable extramedullary plasmacytoma lesions.

Who cannot join

  • Treatment with the following therapies within the specified period:
  • 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;
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  • Any clinical trial therapy within 4 weeks prior to the start of infusion of Meta10-BCMA, or ongoing participation in other clinical trials.
  • Following disease or surgical history:
  • ≥ 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.;
  • Uncontrollable and active infections during the screening period regarded by the investigators;
  • Subjects infected with human immunodeficiency virus (HIV);
  • Subjects with active hepatitis B (defined as hepatitis B surface antigen positive or hepatitis B core antibody positive, concomitant hepatitis B virus DNA level > 100 IU/ml);
  • The hepatitis C virus (HCV) antibody is positive, and the peripheral blood HCV RNA is positive;
  • Subjects with severe electrolyte disturbance regarded by the investigators;
  • Subjects with a clear gastrointestinal bleeding tendency, including the following: active local ulcer lesions, and fecal occult blood (≥ ++); subjects with a history of melena and hematemesis within two months prior to screening; Subjects who may have a major gastrointestinal bleeding history;
  • Subjects with a history of solid organ transplantation;
  • Subjects with other acute, severe, or chronic medical or psychological conditions regarded by investigators as not suitable for enrollment;
  • Pregnant or lactating women.
  • Prohibited treatment and/or medication:
  • Ongoing therapy with other anti-tumor drugs, including traditional Chinese medicine;
  • On-going therapy with drugs that extend the QT interval (including Class Ia and III antiarrhythmic drugs);
  • Subjects who need to receive oxygen daily;
  • Long-term use of corticosteroids (except for local inhalation).
  • Others:
  • Subject with a history of psychotropic substance abuse who are unable to quit or have mental disorders;
  • Subjects with concomitant diseases or comorbidities that could seriously endanger the safety of the patient or affect the completion of the trial as judged by the investigators;
  • There are not enough unmobilized mononuclear cells available for collection for CAR-T cell production.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingbing Wang, PhD contact

86+13856007984

wangxingbing@ustc.edu.cn

China1 site, 1 recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Xingbing Wang, PhD, 86+13856007984, wangxingbing@ustc.edu.cn

    Xingbing Wang, PhD

    Recruiting

Other trials in China

About this study

A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.

Read the detailed description

This is an open-label study. This study is indicated for relapsed or refractory Plasma Cell Neoplasms.The selections of dose levels and the number of subjects are based on clinical trials of similar products and the outcomes of our preliminary clinical studies.

  1. Main research objectives: To evaluate the safety and tolerability of metabolically armed BCMA CAR-T Cells in the treatment of r/r plasma cell neoplasms.
  2. Secondary research objectives: (1)To evaluate the pharmacokinetic (PK) and pharmacodynamics (PD) characteristics of metabolically armed BCMA CAR-T cells after infusion. (2) To evaluate tumor remission after infusion of metabolically armed BCMA CAR-T Cells.
Being tested
Metabolically Armed BCMA CAR-T cells.
Keywords
Meta10-BCMA, CAR-T Cells Therapy, r/r plasma cell neoplasms
Medical subject headings
Multiple Myeloma, Leukemia, Plasma Cell, Immunoglobulin Light-chain Amyloidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolically Armed BCMA CAR-T cells.Drug

    Also called Meta10-BCMA

    Each subject receive metabolically armed BCMA CAR- T cells by intravenous infusion.

Study groups in NCT07085559
Study groupRoleWhat they receive
Administration of Metabolically Armed BCMA CAR-T cells.ExperimentalPatients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine before CAR-T cells infusion. The study will design metabolically armed BCMA CAR-T cells(Meta10-BCMA) with different structures. A dose of Meta10-BCMA CAR-T cells will be infused on day 0.
Receives: Drug: Metabolically Armed BCMA CAR-T cells.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD

    Determine the Maximal Tolerable Dose(MTD)

    Measured: MTD will be determined based on DLTs observed during the first 35 days of study treatment.

  2. Adverse events (AEs)

    Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

    Measured: 1 year post Meta10-BCMA infusion

Secondary outcomes (8)

  1. Cmax

    The maximum concentration (Cmax) of CAR-T cell expansion in peripheral blood

    Measured: 1 year post Meta10-BCMA infusion

  2. Pharmacodynamics

    Concentration levels of CAR-T related serum cytokines such as CRP, IL-6, INF-γ at each time point.

    Measured: Up to 28 days after infusion

  3. Objective response rate (ORR)

    According to the IMWG 2016 version, evaluate the overall tumor response rate (including sCR, CR, VGPR, PR) and the number of subjects in each dose group and all subjects at 1 month, 3 months, 6 months, 9 months and 12 months after CAR-T treatment.

    Measured: 1 year post Meta10-BCMA infusion

  4. Overall survival (OS)

    OS is measured from the date of the infusion of Meta10-BCMA to the date of the subjects' death.

    Measured: 1 year post Meta10-BCMA infusion

  5. Progression-free survival (PFS)

    The time from the start of Meta10-BCMA treatment for the subjects to the first disease progression or death for any reason.

    Measured: 1 year post Meta10-BCMA infusion

  6. Tmax

    The time to reach the maximum concentration (Tmax)

    Measured: 1 year post Meta10-BCMA infusion

  7. AUC0-28d

    The area under the curve AUC0-28d at 28 days.

    Measured: 1 year post Meta10-BCMA infusion

  8. AUC0-90d

    The area under the curve AUC0-90d at 90 days.

    Measured: 1 year post Meta10-BCMA infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start23 Jun 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion15 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07085559
Sponsor's protocol ID
LM-META10-BCMA-11
Status last verified
Jul 2025
First submitted
14 Jul 2025
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Metabolically Armed BCMA CAR-T cells. in people with Multiple Myeloma (MM) and Plasma Cell Leukemia (PCL), run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xingbing Wang, PhD (86+13856007984, wangxingbing@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: MTD will be determined based on DLTs observed during the first 35 days of study treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07085559.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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