BridgeMD
Tests treatment safety and results for Multiple Myeloma
Official title To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
ClinicalTrials.gov ID: NCT06045091
What this study is testing
What is Human BCMA targeted CAR-NK cells injection?
Human BCMA targeted CAR-NK cells injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as BCMA CAR-NK.
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 study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
- 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 18 and older
You may be able to join if
- people must meet all of the following criteria to be enrolled:
- people volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial...
- 18 years and older, Male and female;
- Expected survival \> 12 weeks;
- Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by...
You likely can't join if
- Any one of the following conditions cannot be selected as a subject：
- Accompanied by other uncontrolled malignancies;
- people with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the...
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6...
- people who are considered unsuitable to participate in this trial by the investigator.
- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner...
See the full eligibility criteria
- people must meet all of the following criteria to be enrolled:
- people volunteer to participate in clinical trials, understand and sign the informed consent document, be willing to complete all the trial procedures;
- 18 years and older, Male and female;
- Expected survival \> 12 weeks;
- Documented evidence of multiple myeloma at diagnosis as defined by IMWG updated criteria (2014), or plasma cell leukemia at diagnosis as defined by Diagnosis and therapeutic criteria of hematologic disease (4th edition);
- One of the following indicators is satisfied:
- Serum M protein: IgG M protein ≥5 g/L; or IgA M protein ≥5 g/L; or IgD M protein and IgD \>ULN;
- Urine M protein ≥200 mg/24h;
- Affected serum free light chain ≥100 mg/L and Serum free light chain ratio is abnormal;
- Clonal bone marrow plasma cells ≥10 % for non-secretory myeloma;
- Patients with relapsed/refractory multiple myeloma or plasma cell leukemia, satisfying:
- Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory;
- Progress is documented within 60 days of the most recent anti-tumor treatment, or how well it works assessment does not reach minimal response(MR) or above;
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min;
- Left ventricular ejection fraction \> 50%;
- Baseline peripheral oxygen saturation \> 95%;
- Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN;
- Blood routine examination satisfying hemoglobin≥60 g/L, neutrophils≥ 1.0×10\^9/L, and platelets≥30×10\^9/L, can complete this trial according to the judgement of investigators.
- Any one of the following conditions cannot be selected as a subject：
- Accompanied by other uncontrolled malignancies;
- people with positive Hepatitis B surface antigen(HBsAg) or Hepatitis B core antibody (HBcAb) and hepatitis B virus (HBV) DNA titers higher than the lower limit of the normal range of the investigative site; Hepatitis C...
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months...
- people who are considered unsuitable to participate in this trial by the investigator.
- Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
- Received CAR-NK treatment or other gene therapies before enrollment;
- people who have a disease that affects the signing of written informed consent or who are unable to comply with research procedures; or who are unwilling or unable to comply with research requirements;
- people who have had severe immediate hypersensitivity reactions to any drugs used in this research;
- Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
- In the past two years, the terminal organ was damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic...
- Patients with symptoms of central nervous system.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.