Actively Recruiting
A Single-arm Single-center Trial of BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-03-24
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a low-dose BCMA/CD3 bispecific antibody called CM336 in patients newly diagnosed with systemic light chain (AL) amyloidosis. This is a phase 2, prospective, single-arm clinical study conducted at a single center to better understand how well this treatment works and how safe it is for these patients. Treatment consists of up to 12 cycles of weekly subcutaneous injections of CM336. The dosing starts with a step-up approach during the first week, beginning with 3 mg on Day 1, increasing to 20 mg on Day 4, and then 40 mg weekly from Day 8 onward. Patients who achieve a very good partial response or better after 4 cycles may have their dosing frequency reduced to every two weeks from Cycle 5 onward. Participants will be monitored throughout the treatment for hematologic and organ responses, as well as adverse events. The main outcomes being measured include the rate of very good partial hematologic response or better at 4 months and the incidence and severity of side effects up to 30 days after the last dose, with follow-up extending up to 36 months for survival outcomes. Various laboratory tests, clinical assessments, and response evaluations will be conducted to track treatment effects and safety.
CONDITIONS
Brief Title
BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has voluntarily signed the informed consent form.
- Age 18 years or older, any sex.
- Confirmed diagnosis of primary light-chain (AL) amyloidosis per 2021 guidelines.
- Measurable disease at screening with specified free light chain criteria.
- ECOG performance status of 2 or less.
- Adequate organ function within 3 days before first dose, meeting blood count, liver, coagulation, and kidney function criteria.
- Male and female patients of childbearing potential and their partners agree to use effective contraception during treatment and for at least 3 months after.
- Male patients agree not to donate sperm from screening until 90 days after last dose.
- Willing and able to comply with all study procedures and follow-up visits.
- Women not of childbearing potential are eligible; women of childbearing potential must have a negative pregnancy test at screening.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 cycles (28 days per cycle)
Participants receive up to 12 cycles of subcutaneous CM336 with a step-up dosing strategy during the first week. Dose frequency may be reduced for participants achieving a very good partial response by Cycle 4.
Weekly visits during Cycle 1 and Cycle 4, then weekly or every two weeks depending on response
Duration - Up to approximately 24 months
Participants are monitored for safety and efficacy endpoints including hematologic and organ response after treatment completion.
Visits for safety and efficacy assessments up to 24 months after last dose
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China, 300000
Actively Recruiting
Research Team
G
Gang An, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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