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New treatment option for Relapsed or Refractory Multiple Myeloma (RRMM)
Official title Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
ClinicalTrials.gov ID: NCT07003555
What this study is testing
What is Dual-targeting BCMA-CD19 CAR-T cell infusion?
Dual-targeting BCMA-CD19 CAR-T cell infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory multiple myeloma (rrmm).
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 a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - CD19 CAR-T cell therapy.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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 75
You may be able to join if
- Voluntarily participate in the trial and have good compliance.
- Aged between 18 and 75 years old, regardless of gender.
- Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have...
- Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
- Organ functions: ① Cardiac function: Left ventricular ejection fraction \> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine...
You likely can't join if
- Pregnant or lactating women.
- Active infections that have not been effectively controlled.
- Active autoimmune diseases that have not been effectively controlled.
- Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
- For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
- Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA...
See the full eligibility criteria
- Voluntarily participate in the trial and have good compliance.
- Aged between 18 and 75 years old, regardless of gender.
- Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.
- Positive for BCMA in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
- Organ functions: ① Cardiac function: Left ventricular ejection fraction \> 50% (by echocardiogram) in the past 2 weeks. ② Liver function: Alanine aminotransferase and aspartate aminotransferase \ 95%. ⑥ Pulmonary...
- Female patients of childbearing age must have a negative serum pregnancy test at screening and before receiving cyclophosphamide and fludarabine or melphalan treatment; male patients should be willing to use effective...
- ECOG score ≤ 2.
- Expected survival time \> 3 months.
- Pregnant or lactating women.
- Active infections that have not been effectively controlled.
- Active autoimmune diseases that have not been effectively controlled.
- Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
- For allogeneic transplant patients, active graft - versus - host disease (GVHD) that has not been effectively controlled.
- Presence of any of the following: HBV - DNA copy number above the lower limit of detection; positive hepatitis C antibody (HCV - Ab) with HCV - RNA copy number above the lower limit of measurability; positive anti -...
- Allergic or intolerant to fludarabine or cyclophosphamide.
- Suffering from known symptomatic non - plasma cell infiltrative central nervous system diseases.
- Uncontrollable cardiovascular and cerebrovascular diseases within 6 months, such as: a. New York Heart Association (NYHA) class III or IV congestive heart failure. b. Myocardial infarction occurred or coronary artery...
- A history of other untreated malignancies within the past 5 years or having other untreated malignancies concurrently.
- The investigator assesses that the subject cannot or is unwilling to comply with the requirements of the study protocol.
- Previous use of a CAR - T vector with the same structure.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.