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New treatment option for Ultra High Risk mm (uhr-mm), 18-70 Years Old, Suitable for ASCT. And...
Official title Autologous Transplantation Combined With BCMA CAR-T in the Treatment of UHR-MM
ClinicalTrials.gov ID: NCT07109323
What this study is testing
What is BCMA CART?
BCMA CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ultra high risk mm (uhr-mm), 18-70 years old, suitable for asct. and meet any of the following uhr-mm definitions.
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
- To evaluate the safety and efficacy of autologous hematopoietic stem cell transplantation (ASCT) combined with BCMA-CART in the treatment of UHR-MM.
- 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 70
You may be able to join if
- people must meet all of the following criteria to be enrolled: Ultra high risk mm (UHR-MM), 18-70 years old, suitable for ASCT. And meet any of the...
- The people voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;
- The subject must have proper organ function and meet all the following inspection results: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit...
You likely can't join if
- people who have one or more of the following cannot be selected for this study:
- Have a history of allergy to any component in cell products;
- Serious heart disease, including but not limited to: Myocardial infarction, cardiac angioplasty or stent implantation within 6 months before signing...
- History of autologous / allogeneic hematopoietic stem cell transplantation;
- Stroke or seizure within 6 months before signing ICF;
- Have autoimmune disease, immune deficiency or other diseases requiring immunosuppressant treatment;
See the full eligibility criteria
- people must meet all of the following criteria to be enrolled: Ultra high risk mm (UHR-MM), 18-70 years old, suitable for ASCT. And meet any of the following definitions of UHR-MM: 1) cytogenetic ultra-high risk, which...
- The people voluntarily participated in the study and signed the informed consent form (ICF) by themselves or their legal guardians;
- The subject must have proper organ function and meet all the following inspection results: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate...
- people who have one or more of the following cannot be selected for this study:
- Have a history of allergy to any component in cell products;
- Serious heart disease, including but not limited to: Myocardial infarction, cardiac angioplasty or stent implantation within 6 months before signing ICF Unstable angina Severe arrhythmia History of severe non ischemic...
- History of autologous / allogeneic hematopoietic stem cell transplantation;
- Stroke or seizure within 6 months before signing ICF;
- Have autoimmune disease, immune deficiency or other diseases requiring immunosuppressant treatment;
- Within 3 years before signing the ICF, patients with malignant tumors other than multiple myeloma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer...
- The presence of uncontrolled active infection;
- Unstable systemic diseases judged by the investigator: including but not limited to serious liver, kidney or metabolic diseases requiring drug treatment;
- Any of the following conditions exist within 1 week before lymphocyte collection: The detection value of hepatitis B virus (HBV) DNA in peripheral blood was higher than the lower limit of detection Hepatitis C virus...
- More than 5mg/d prednisone (or equivalent amount of other corticosteroids) was applied within 1 week before lymphocyte collection Vegan);
- Have used any car-t cell products or other genetically modified T cell therapies;
- Received BCMA targeted therapy;
- Have a history of live vaccination within 4 weeks before signing ICF;
- Have a history of alcohol abuse, drug abuse or mental illness;
- Other researchers consider it inappropriate to participate in this study. -
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin 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.