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

NCT07175493 | Recruiting Phase 1

• 1 other identifier: CM336-125101
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Autoimmune Cytopenia; Immune Thrombocytopenia (ITP); Autoimmune Hemolytic Anemia; Evans Syndrome

Outcome Measures

Primary Outcomes (4)

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

  Safety will be assessed by monitoring the incidence, nature, and severity of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), graded according to NCI CTCAE v5.0 and American Society for Transplantation and Cellular Therapy(ASTCT) criteria. Dose interruptions, modifications, or discontinuations due to toxicity will also be recorded.

  52 weeks

• Efficacy of CM336

  Overall hematological response rate within 8 weeks

  8 weeks

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

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

  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.

  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.

  up to 52 weeks.

Study Arms (1)

CM336 injection

EXPERIMENTAL

Biological: CM336 Injection

Interventions

CM336 Injection BIOLOGICAL

subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol

CM336 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (3)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

RECRUITING

Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Anemia, Hemolytic, Autoimmune; Evans Syndrome

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Anemia, Hemolytic; Anemia

Central Study Contacts

Qian Jia

CONTACT

86+028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 16, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): November 18, 2027
• Study Completion (Estimated): November 18, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

CN (3)