RecruitingPhase 1/2

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

China158 participantsStarted 2025-11-18

Plain-language summary

To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 52 weeks

Efficacy of CM336

Timeframe: 8 weeks

Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.

Timeframe: up to 52 weeks.

Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.

Timeframe: up to 52 weeks.

Trial details

NCT IDNCT07175493

SponsorKeymed Biosciences Co.Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-18

Contact for this trial

Qian Jia

86+028-88610620 qianjia@keymedbio.com

View on ClinicalTrials.gov More Autoimmune Cytopenia trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: 52 weeks

Efficacy of CM336

Timeframe: 8 weeks

Proportion of ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.

Timeframe: up to 52 weeks.

Proportion of AIHA subjects with at least one instance of hemoglobin ≥ 100 g/L, and an increase ≥ 20 g/L compared to the baseline level.

Timeframe: up to 52 weeks.