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Tests treatment safety and results for Light Chain Amyloidosis
Official title Exploratory Clinical Study on the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent/Refractory Light Chain Amyloidosis
ClinicalTrials.gov ID: NCT06983951
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 light chain amyloidosis.
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 multicenter, open label, fixed dose exploratory clinical trial with an expected enrollment of 30 subjects. The main objective is to evaluate the safety of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, preliminarily verify the effectiveness of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, and explore the pharmacokinetic, pharmacodynamic, and immunogenic characteristics of targeted BCMA autologous CART cell injection after reinfusion.
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
- \- Participants must meet all , and only those who do not meet any
You likely can't join if
- can be enrolled
- Participants must personally sign the informed consent form approved by the ethics committee in writing before the start of the study;
- The age of the subject is ≥ 18 years old;
- Diagnosed with light chain amyloidosis through pathological examination;
- people with recurrent/refractory light chain amyloidosis who have previously received second-line or higher treatment;
- dFLC \> 50mg/L
See the full eligibility criteria
- \- Participants must meet all , and only those who do not meet any
- can be enrolled
- Participants must personally sign the informed consent form approved by the ethics committee in writing before the start of the study;
- The age of the subject is ≥ 18 years old;
- Diagnosed with light chain amyloidosis through pathological examination;
- people with recurrent/refractory light chain amyloidosis who have previously received second-line or higher treatment;
- dFLC \> 50mg/L
- Expected survival period ≥ 12 weeks;
- ECOG score ≤ 2 points;
- Female people with fertility should agree to take effective contraceptive measures from the date of signing the informed consent form until 365 days after reinfusion. Effective contraceptive measures are defined as...
- Prior to enrollment, participants must have appropriate organ function and meet all of the following test results: 9.1 Absolute neutrophil count ≥ 1.0 × 109/L [allowed to use granulocyte colony-stimulating factor...
- people who have received the following previous treatments: 1.1 Individuals who have received gene therapy prior to enrollment; 1.2 people who received live vaccines within 4 weeks prior to enrollment; 1.3 Received...
- Patients with central involvement or complete intestinal obstruction;
- Patients with moderate to severe pleural and peritoneal effusion who are difficult to control with conventional treatment and require continuous catheterization and drainage;
- Active malignant tumors within the past 5 years, unless they are curable tumors that have been significantly cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc;
- people with positive hepatitis B B surface antigen (HBsAg) and abnormal detection of HBV DNA in peripheral blood (abnormal detection of HBV DNA is defined as: quantitative detection of HBV DNA is higher than the...
- There are uncontrollable active infections (excluding CTCAE grade 2 urinary and reproductive system infections and upper respiratory tract infections);
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification ≥ III), 24-hour dynamic electrocardiogram...
- Hypertensive people who cannot be controlled by drug treatment;
- Previous treatment toxicity reactions have not improved to baseline or ≤ grade 1 (NCI-CTCAE v5.0 version, except for hair loss and clinically insignificant laboratory test abnormalities);
- Have undergone major surgery within 2 weeks prior to enrollment, or plan to undergo surgery during the waiting period for reinfusion or within 12 weeks after receiving study treatment (excluding planned local anesthesia...
- Solid organ transplant recipients;
- Pregnant or lactating women;
- people with previous central nervous system disorders (such as cerebral aneurysms, epilepsy, stroke, senile dementia, mental illness, etc.) or consciousness disorders;
- Other researchers have identified unstable systemic diseases, including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
- Known to have life-threatening allergic reactions, hypersensitivity reactions, or intolerance to cellular preparations or their components;
- Patients diagnosed by researchers as having bleeding, severe thrombosis, or genetic/acquired bleeding and severe thrombosis (including hemophilia, coagulation dysfunction, thrombocytopenia, splenomegaly, etc.), or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 Beijing, Beijing 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.