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Tests treatment safety and results for Multiple Myeloma (MM)
Official title Safety and Efficacy of Metabolically Armed BCMA CAR-T Cells (Meta10-BCMA) in the Treatment of r/r Plasma Cell Neoplasms Clinical Research
ClinicalTrials.gov ID: NCT07085559
What this study is testing
What is Metabolically Armed BCMA CAR-T cells.?
Metabolically Armed BCMA CAR-T cells. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma (mm).
Also referred to as Meta10-BCMA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Study of Metabolically Armed BCMA CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Plasma Cell Neoplasms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 75
You may be able to join if
- Age 19 to 75 years old, male or female. The subject or his/her guardian voluntarily signed the informed consent;
- people with relapsed or refractory Plasma Cell Neoplasms（including Multiple Myeloma, Plasma Cell Leukemia, AL Amyloidosis）according to IMWG criteria...
- Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.
- The people were unable to receive autologous hematopoietic stem cell transplantation treatment, or relapsed after autologous hematopoietic stem cell...
- ECOG performance score 0-2 (except for people with central nervous system invasion, which needs to be confirmed by the investigator).
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- Age 19 to 75 years old, male or female. The subject or his/her guardian voluntarily signed the informed consent;
- people 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...
- Evidence of cell membrane BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue.
- The people 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...
- ECOG performance score 0-2 (except for people with central nervous system invasion, which needs to be confirmed by the investigator).
- Estimated life expectancy≥12 weeks.
- people 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...
- 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 people 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 people 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.
What rules you out
- 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) people with a history of Torsades de pointes...
- people 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...
- Uncontrollable and active infections during the screening period regarded by the investigators;
- people infected with human immunodeficiency virus (HIV);
- people 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;
- people with severe electrolyte disturbance regarded by the investigators;
- people with a clear gastrointestinal bleeding tendency, including the following: active local ulcer lesions, and fecal occult blood (≥ ++); people with a history of melena and hematemesis within two months prior to...
- people with a history of solid organ transplantation;
- people 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);
- people 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;
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.