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

NCT07085559 | Recruiting Early Phase 1

• 1 other identifier: LM-META10-BCMA-11
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma (MM); Plasma Cell Leukemia (PCL); AL Amyloidosis (AL)

Keywords

Meta10-BCMA; CAR-T Cells Therapy; r/r plasma cell neoplasms

Outcome Measures

Primary Outcomes (2)

• MTD

  Determine the Maximal Tolerable Dose(MTD)

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

• Adverse events (AEs)

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

  1 year post Meta10-BCMA infusion

Secondary Outcomes (8)

• Cmax

  1 year post Meta10-BCMA infusion

• Pharmacodynamics

  Up to 28 days after infusion

• Objective response rate (ORR)

  1 year post Meta10-BCMA infusion

• Overall survival (OS)

  1 year post Meta10-BCMA infusion

• Progression-free survival (PFS)

  1 year post Meta10-BCMA infusion

Study Arms (1)

Administration of Metabolically Armed BCMA CAR-T cells.

EXPERIMENTAL

Patients 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.

Drug: Metabolically Armed BCMA CAR-T cells.

Interventions

Metabolically Armed BCMA CAR-T cells. DRUG

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

Also known as: Meta10-BCMA

Administration of Metabolically Armed BCMA CAR-T cells.

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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；

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Leman Biotech Co., Ltd.: collaborator

Study Sites (1)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell; Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Xingbing Wang, PhD

CONTACT

86+13856007984; wangxingbing@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 25, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)