Autoimmune CytopeniaPhase 1/2NCT07175493
A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia
A Phase 1/2 study testing CM336 Injection in people with Autoimmune Cytopenia and Immune Thrombocytopenia (ITP), run by Keymed Biosciences Co.Ltd at 3 sites in China.
Trial summary
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Cytopenia, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia
- What is being tested?
- CM336 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 3 sitesChina
- Study dates
- 18 Nov 2025to 18 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Xuliang Shen Heping Hospital Affiliated to Changzhi Medical College, 028-88610620, qianjia@keymedbio.com
- Recruiting
Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality
Lei Zhang, 86+022-23608025, zhanglei1@ihcams.ac.cn
Jun Shi, 86+022-23608025, shijun@ihcams.ac.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Hu Zhou Henan Cancer Hospital, 028-88610620, qianjia@keymedbio.com
About this study
Official title: A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia
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
- Being tested
- CM336 Injection
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Anemia, Hemolytic, Autoimmune, Evans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM336 InjectionBiological
subcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| CM336 injection | Experimental | Not described Receives: Biological: CM336 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 52 weeks
Efficacy of CM336
Overall hematological response rate within 8 weeks
Measured: 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.
Measured: 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.
Measured: up to 52 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start18 Nov 2025
- Primary completion18 Nov 2027 (estimated)
- Study completion18 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune CytopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175493
- Sponsor's protocol ID
- CM336-125101
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study of CM336 Injection in Patients With Relapsed or Refractory Autoimmune Cytopenia
- ClinicalTrials.gov ID
- NCT07175493
- Acronym / sponsor ID
- CM336-125101
- Conditions
- Autoimmune Cytopenia, Immune Thrombocytopenia (ITP), Autoimmune Hemolytic Anemia, Evans Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 18 Nov 2027 (estimated)
- Study completion
- 18 Nov 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of CM336 (BCMA/CD3 Bispecific Antibody) in the treatment of patients with relapsed or refractory autoimmune cytopenia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM336 injection | Experimental | Biological: CM336 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM336 Injectionsubcutaneous CM336 administration, step-up dosing, Dose and frequency of CM336 according to the protocol | Biological | CM336 injection |
Primary outcome
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 52 weeks
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.
Efficacy of CM336
Time frame: 8 weeks
Overall hematological response rate within 8 weeks
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 ITP subjects with a platelet count ≥ 50 × 10^9/L at least twice during the visit.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Related trials for Autoimmune Cytopenia
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 3
A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP)
Chronic Primary Immune Thrombocytopenia (ITP)
Active, not recruitingPhase 2
A Study of Ianalumab (VAY736) in Patients With Primary Immune Thrombocytopenia (ITP) Previously Treated With at Least Two Lines of Therapies
Primary Immune Thrombocytopenia (ITP)
RecruitingPhase 1/2
Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Warm Autoimmune Hemolytic Anemia (WAIHA), ITP - Immune Thrombocytopenia
Active, not recruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CM336 Injection in people with Autoimmune Cytopenia and Immune Thrombocytopenia (ITP), run by Keymed Biosciences Co.Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (86+028-88610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 52 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.