ClinicalTrials.gov record NCT07039578

Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Light-Chain Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

An Open-Label, Multi-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of CM336 Injection in the Treatment of Relapsed or Refractory Primary Light-Chain Amyloidosis

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

LocationChina

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This phase 2, open-label study tests CM336 injection in adults with relapsed or refractory primary light-chain (AL) amyloidosis. Participants are randomized to a low- or high-dose subcutaneous CM336 schedule with step-up dosing and followed to assess safety and hematologic complete response. The main measure is hematologic complete response rate, assessed up to 3 years.

What it is studying. Tests the safety of subcutaneous CM336 and measures hematologic complete response rate in adults with relapsed or refractory primary light-chain (AL) amyloidosis. The study compares two dose levels (low versus high).

What the researchers hope to learn. To evaluate the efficacy and safety of CM336 injection in relapsed or refractory primary light-chain (AL) amyloidosis by measuring hematologic complete response rates and safety outcomes, and to compare those outcomes between low and high dose groups.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

to Evaluate the Efficacy and Safety of CM336 (BCMA/CD3 Bispecific Antibody) in Adults with Relapsed or Refractory Primary Light-Chain Amyloidosis

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological: CM336 Injection(Low dose group)
CM336 Injection(High dose group)

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Voluntary provision of written informed consent and ability to comply with protocol requirements.
Age ≥18 years, any gender.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
Confirmed diagnosis of primary light-chain (AL) amyloidosis.
Relapsed or refractory primary AL amyloidosis.
Measurable hematologic disease at screening (per protocol-defined criteria).
Involvement of ≥1 amyloid-affected organ.
Adequate organ function meeting all protocol-specified criteria within 3 days prior to first dose.

Exclusion criteria

Current or prior diagnosis of multiple myeloma.
Received anti-AL amyloidosis therapy within protocol-specified timeframe prior to first dose.
Clinically significant cardiovascular or cerebrovascular disease.
Any active or uncontrolled infection meeting protocol-defined criteria.
Any other condition deemed by the Investigator to preclude safe study participation.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomized to a low‑dose or high‑dose CM336 group and receive subcutaneous CM336 injections with step‑up dosing per the protocol; the study is open‑label (no masking). Screening assessments will confirm measurable disease and adequate organ function before dosing. After enrollment there are regular study visits for dosing, monitoring, and assessments of hematologic response for up to three years. The registry record does not list other specific invasive procedures; exact dosing schedule and additional tests are defined in the study protocol.

How the study is structured. Phase 2, interventional, randomized, open-label study with parallel assignment. Adults are assigned to one of two experimental arms (low-dose or high-dose CM336). CM336 is given subcutaneously with step-up dosing. Outcomes, including hematologic complete response, are followed for up to 3 years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jul 25, 2025
Primary completion: Jun 30, 2026 (estimated)
Study completion: Jul 31, 2029 (estimated)
Target enrollment: 90 participants (estimated)
Last updated on registry: Nov 26, 2025
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Keymed Biosciences Co.Ltd

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Qian Jia 📞 028-88610620 ✉ qianjia@keymedbio.com

Participating sites (2)

Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality · China
- Jian Li · 86+18610852525 · lijian@pumch.cn
Institute of Hematology & Blood Diseases HospitalRecruiting
Tianjin, Tianjin Municipality · China
- Gang An · 86+13502181109 · angang@ihcams.ac.cn

Terms used on this page · explanations by MedicalUpdates.ai

Bispecific Antibody: An engineered antibody that attaches to two targets at once, often linking an immune cell to a diseased cell so the immune cell can attack it.
Relapsed or Refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECOG: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
at screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
timeframe: The period over which an outcome is measured, for example 'at 12 weeks'. It is not necessarily the total length of the study.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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