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New treatment option for Systemic Light Chain Amyloidosis
Official title BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
ClinicalTrials.gov ID: NCT07151690
What this study is testing
What is anti-BCMA/CD3 bispecific antibody?
anti-BCMA/CD3 bispecific antibody is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for systemic 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 is a prospective, single-arm, single-center clinical study designed to evaluate the efficacy and safety of low-dose BCMA/CD3 bispecific antibody (CM336) in patients newly diagnosed with systemic light chain (AL) amyloidosis.
- 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 and older
You may be able to join if
- The patient is informed of and voluntarily signs the informed consent form (ICF).
- Age ≥18 years, regardless of sex.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic...
- Measurable disease at screening, defined as:
- Difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or
See the full eligibility criteria
- The patient is informed of and voluntarily signs the informed consent form (ICF).
- Age ≥18 years, regardless of sex.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis, in accordance with the Guidelines for the Diagnosis and Treatment of Systemic Light-chain Amyloidosis (2021 Revision).
- Measurable disease at screening, defined as:
- Difference between involved and uninvolved free light chains (dFLC) ≥50 mg/L, or
- Serum involved free light chain ≥50 mg/L with an abnormal κ:λ ratio.
- ECOG performance status ≤2.
- Adequate organ function within 3 days prior to the first dose of the investigational drug, meeting all of the following criteria: i. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, with no granulocyte colony-stimulating...
- Male and female patients of childbearing potential, and their partners, must agree to use effective contraceptive methods deemed appropriate by the investigator throughout the treatment period and for at least 3 months...
- Male patients must agree not to donate sperm from the screening period until 90 days after the last dose of the investigational drug.
- The patient must be willing and able to comply with all study procedures and follow-up visits.
- Women not of childbearing potential are eligible for enrollment. Women of childbearing potential must have a negative serum or urine β-hCG pregnancy test at screening. Note: A woman of childbearing potential is defined...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
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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.