ClinicalTrials.gov record NCT07175493

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia

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 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
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 interventional Phase 1/2 study gives subcutaneous CM336 with step-up dosing to people with relapsed or refractory autoimmune cytopenias such as ITP, autoimmune hemolytic anemia, or Evans syndrome. The study will monitor safety and treatment-emergent adverse events and measure blood responses (platelets or hemoglobin) over time. Primary efficacy is measured within 8 weeks; safety outcomes are followed up to 52 weeks.

What it is studying. The study is testing the safety and hematologic activity of CM336 in people with relapsed or refractory autoimmune cytopenias. It will record adverse events (including events of special interest such as cytokine release syndrome and neurotoxicity) and measure blood-count responses (overall hematological response, platelet increases for ITP, hemoglobin increases for AIHA) during follow-up.

What the researchers hope to learn. To evaluate the safety of CM336 by documenting treatment-emergent adverse events and serious adverse events (including cytokine release syndrome and immune effector cell-associated neurotoxicity). To assess hematological responses, including overall response within 8 weeks and specific platelet and hemoglobin response measures up to 52 weeks.

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 the treatment of patients with relapsed or refractory autoimmune cytopenia

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

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, male or female.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Confirmed diagnosis of immune thrombocytopenia (ITP), warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), mixed autoimmune hemolytic anemia (mAIHA) or Evans Syndrome.
  • Relapsed or refractory autoimmune hemolytic anemia.

Exclusion criteria

  • Secondary ITP or AIHA caused by any reason. Subjects with positive autoimmune antibodies but without a clear diagnosis of any other autoimmune diseases are allowed to be enrolled.
  • Other types of AIHA or other types of cytopenia
  • History of critical diseases that, in the opinion of the investigator, may pose a risk to the safety of subjects or whose exacerbation during the study could compromise the efficacy or safety analysis of the results.
  • Received any treatment of anti-B Cell Maturation Antigen(BCMA) antibody.
  • Evaluated unsuitable to participant in this study by investigator.

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 will receive subcutaneous injections of the study drug CM336 using step‑up dosing according to the protocol. They will have regular clinic visits for safety monitoring and blood tests to check blood counts (for example platelets and hemoglobin) and to watch for treatment‑related adverse events, including cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS). Dose interruptions, modifications, or discontinuation for toxicity may occur and will be recorded. Follow‑up and safety assessments are planned for up to 52 weeks.

How the study is structured. An open-label, interventional Phase 1/2 study with sequential dosing. Participants receive subcutaneous CM336 using a step-up dosing schedule in a single experimental arm. There is no masking; safety and blood responses are tracked over weeks to months (primary safety follow-up up to 52 weeks).

Questions you could ask

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

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • 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 Evans syndrome

This trial is also listed on this site under autoimmune hemolytic anemia.

Clinical trials7 trials listed for Evans syndromeEvery trial the registry lists for Evans syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Evans syndrome researchLatest monthly update: September 2026. Includes: Genetic immune disorders. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Nov 18, 2025
Primary completion
Nov 18, 2027 (estimated)
Study completion
Nov 18, 2028 (estimated)
Target enrollment
158 participants (estimated)
Last updated on registry
Dec 17, 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.

Participating sites (3)

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.
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.

← Back to clinical trials