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New treatment option for Relapsed/Refractory Light Chain Amyloidosis
Official title Autologous BCMA-targeted CAR-T Cell Injection for Relapsed/Refractory Light Chain Amyloidosis
ClinicalTrials.gov ID: NCT07626476
What this study is testing
What is Targeted BCMA Autologous CART Cell Injection?
Targeted BCMA Autologous CART Cell Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for relapsed/refractory 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
- Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs.
- 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
- The participant must personally sign an ethics-committee-approved informed consent form before study start.
- Age ≥18 years.
- Pathologically confirmed light chain amyloidosis.
- Relapsed/refractory light chain amyloidosis previously treated with 2 or more lines of therapy.
- dFLC \>50 mg/L.
You likely can't join if
- Participants who have received the following prior treatments:
- Prior gene therapy before enrollment.
- Live vaccine injection within 4 weeks before enrollment.
- Other treatment clinical study drug treatment within 12 weeks before leukapheresis.
- Central nervous system involvement or complete intestinal obstruction.
- Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.
See the full eligibility criteria
- The participant must personally sign an ethics-committee-approved informed consent form before study start.
- Age ≥18 years.
- Pathologically confirmed light chain amyloidosis.
- Relapsed/refractory light chain amyloidosis previously treated with 2 or more lines of therapy.
- dFLC \>50 mg/L.
- Expected survival ≥12 weeks.
- ECOG score ≤2.
- Diagnosis of AL amyloidosis must meet the following conditions: (1) clinical manifestations, physical examination, laboratory or imaging examinations confirm tissue or organ involvement; (2) tissue biopsy pathology...
- Female participants of childbearing potential should agree to use effective contraception from the date of signing informed consent until 365 days after infusion. Effective contraception is defined as abstinence or...
- Adequate organ function before enrollment, meeting all of the following:
- Absolute neutrophil count ≥1.0×10\^9/L; granulocyte colony-stimulating factor (G-CSF) support is permitted.
- Platelet count ≥50×10\^9/L.
- Hemoglobin ≥8 g/dL.
- Bilirubin ≤1.5×upper limit of normal (ULN), except biliary obstruction caused by tumor compression.
- ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN.
- Mayo 2004 stage I-IIIa.
- Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy.
- Baseline oxygen saturation on room air \>92%.
- Participants who have received the following prior treatments:
- Prior gene therapy before enrollment.
- Live vaccine injection within 4 weeks before enrollment.
- Other treatment clinical study drug treatment within 12 weeks before leukapheresis.
- Central nervous system involvement or complete intestinal obstruction.
- Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.
- Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.
- HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.
- Uncontrolled active infection, except CTCAE grade \<2 urogenital infection and upper respiratory tract infection.
- Severe heart disease, including but not limited to unstable angina, myocardial infarction within 6 months before screening, congestive heart failure (New York Heart Association [NYHA] class ≥III), positive six-minute...
- Hypertension that cannot be controlled by medication.
- Toxicity from prior treatment not recovered to baseline or ≤grade 1 according to NCI CTCAE v5.0, except alopecia and clinically insignificant laboratory abnormalities.
- Major surgery within 2 weeks before enrollment, or planned surgery during the waiting period before infusion or within 12 weeks after study treatment, except planned local anesthesia surgery.
- Solid organ transplantation.
- Pregnant or breastfeeding women.
- History of central nervous system disease, such as cerebral aneurysm, epilepsy, stroke, senile dementia or psychiatric disease, or disturbance of consciousness.
- Other systemic disease judged unstable by the investigator, including but not limited to severe hepatic, renal or metabolic disease requiring medication.
- Known life-threatening allergic reaction, hypersensitivity or intolerance to the CAR-T cell product or its components.
- Bleeding or severe thrombosis as judged by the investigator, hereditary/acquired bleeding or severe thrombosis, including hemophilia, coagulopathy, thrombocytopenia and hypersplenism, or current thrombolytic or...
- Other conditions that the investigator considers unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Fengtai District, 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, Fengtai District, 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.