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

Phase 2RecruitingNCT07175493

Keymed Biosciences Co.Ltd158 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

158

Conditions

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

Interventions

CM336 InjectionBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: 52 weeks

Efficacy of CM336

Overall hematological response rate within 8 weeks

Time frame: 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.

Time frame: 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.

Time frame: up to 52 weeks.

Central Contacts

Qian Jia

CONTACT

86+028-88610620 qianjia@keymedbio.com

Data from ClinicalTrials.gov

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