BridgeMD
New treatment option for Relapsed/Refractory Multiple Myeloma
Official title IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia
ClinicalTrials.gov ID: NCT07509086
What this study is testing
What is IL-15-armored CAR-T cells?
IL-15-armored CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory multiple myeloma.
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
- This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study...
- Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD)...
- Age 18 to 80 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Estimated life expectancy \> 3 months from the date of signing the informed consent form.
You likely can't join if
- History within 1 year prior to signing the informed consent form of any of the following:
- New York Heart Association (NYHA) Class III or IV heart failure;
- Myocardial infarction;
- Cardiac angioplasty or stent placement;
- Unstable angina;
- Other clinically significant symptomatic cardiac disease;
See the full eligibility criteria
- Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
- Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status...
- Age 18 to 80 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Estimated life expectancy \> 3 months from the date of signing the informed consent form.
- Hemoglobin ≥ 60 g/L (transfusion permitted).
- Adequate organ function as defined below:
- Creatinine clearance (CrCl) ≥ 40 mL/min, calculated using the Cockcroft-Gault formula;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- Oxygen saturation \> 90% on room air;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Participants of childbearing potential must agree to use effective contraception prior to study enrollment and for at least 6 months after completion of study treatment. Participants who become pregnant or suspect...
- History within 1 year prior to signing the informed consent form of any of the following:
- New York Heart Association (NYHA) Class III or IV heart failure;
- Myocardial infarction;
- Cardiac angioplasty or stent placement;
- Unstable angina;
- Other clinically significant symptomatic cardiac disease;
- Active graft-versus-host disease (GVHD) or requirement for systemic immunosuppressive therapy.
- History of other malignancies within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer...
- Active infection requiring systemic therapy or uncontrolled infection within 7 days prior to screening (excluding mild genitourinary or upper respiratory tract infections).
- Evidence of active viral or infectious disease as follows:
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA above the lower limit of detection;
- Positive hepatitis C virus (HCV) antibody with detectable HCV RNA;
- Positive human immunodeficiency virus (HIV) antibody;
- Positive Treponema pallidum particle agglutination assay (TPPA).
- Participation in another clinical trial within 4 weeks prior to signing the informed consent form, or if the time from the last dose of an investigational drug to informed consent is less than 5 half-lives of that drug...
- History of severe allergic reactions to biologic products.
- Any unstable systemic disease, as judged by the investigator, including but not limited to severe hepatic, renal, or metabolic disorders requiring medical treatment.
- Pregnant or breastfeeding women; women planning to become pregnant within 2 years after cell infusion; or male participants whose partners plan to become pregnant within 2 years after cell infusion.
- Any condition that, in the opinion of the investigator, may increase the participant's risk or interfere with study participation or interpretation of study results.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, 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.