Autoimmune Hemolytic AnemiaPhase 1NCT07816341
Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia
A Phase 1 study testing F182112 single-agent in people with Autoimmune Hemolytic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- F182112 single-agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 31 Dec 2028
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Diagnosis of AIHA according to established Chinese or international criteria, including warm AIHA, mixed AIHA, cold agglutinin disease, or Evans syndrome.
- Refractory to multiple lines of therapy, meeting all of the following: HGB <100 g/L with evidence of hemolytic anemia; Prior treatment with ≥2 immunosuppressive therapies, including a CD20 monoclonal antibody; Glucocorticoid treatment for ≥3 months, unless contraindicated or intolerable; Adequate prior CD20 monoclonal antibody treatment (≥4 doses of 100 mg or 375 mg/m², or 2 doses of 1,000 mg).
- ECOG performance status ≤2.
- Participants and their partners agree to use effective contraception from informed consent through 1 year after study treatment.
- Written informed consent must be obtained before any study-specific screening procedures.
Who cannot join
- Diagnosed lymphoproliferative malignancy.
- Secondary AIHA caused by drugs or infection.
- Congenital immunodeficiency or other inherited or acquired hemolytic disorders.
- Prior organ or hematopoietic stem cell transplantation.
- New thrombotic events or organ infarction within 6 months before enrollment.
- Prior BCMA-targeted therapy within 6 months before enrollment.
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- Any of the following prior treatments within the specified washout periods: Anti-CD20 monoclonal antibody within 12 weeks; Sutimlimab or other approved biologic therapy within 5 half-lives; Plasma exchange within 4 weeks; Splenectomy within 12 weeks.
- Any of the following cardiovascular conditions: LVEF ≤45%; Active cardiac disease or NYHA class III/IV heart failure; Clinically significant arrhythmia requiring treatment, except atrial fibrillation or paroxysmal supraventricular tachycardia; QTc ≥450 ms in males or ≥470 ms in females; Myocardial infarction, coronary artery bypass grafting, or coronary stent placement within 6 months; Other clinically significant cardiac disease considered unsuitable by the investigator.
- Unstable systemic disease, including severe hepatic or renal disease requiring treatment.
- History of another primary malignancy within 5 years before screening, except adequately treated non-melanoma skin cancer, carcinoma in situ, or other malignancies without recurrence for ≥5 years.
- Major surgery within 4 weeks before screening if considered unsuitable for enrollment by the investigator.
- Uncontrolled active fungal, viral, bacterial, tuberculosis, or other infection, or infection requiring intravenous antimicrobial therapy.
- Active or clinically significant HBV, HCV, HIV, or syphilis infection
- Live-virus vaccination within 4 weeks before enrollment.
- Participation in another interventional clinical study within 5 half-lives of the investigational treatment before screening, or planned use of another investigational treatment during this study.
- Pregnant or breastfeeding women.
- Psychiatric disorders, impaired consciousness, or central nervous system disorders, including a history of epilepsy or Parkinson's disease.
- Known hypersensitivity to any component of F182112.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Red Blood Cell Diseases Center and Regenerative Medicine Center
Tianjin, Tianjin Municipality, 301617
Lele Zhang, 02223608328, zhanglele@ihcams.ac.cn
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of F182112 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- F182112 single-agent
- Keywords
- Autoimmune Hemolytic Anemia, F182112
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F182112 single-agentDrug
The dose-escalation phase will evaluate three sequential target dose levels of F182112: 30 μg/kg, 90 μg/kg, and 180 μg/kg, using a standard 3+3 design. F182112 will be administered intravenously using a priming dose followed by a target dose.
| Study group | Role | What they receive |
|---|---|---|
| F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia | Experimental | F182112 is a recombinant humanized anti-BCMA/CD3 bispecific antibody for injection. By binding to CD3 receptors on T cells, F182112 can effectively deplete BCMA-expressing B cells and plasma cells in vivo, thereby alleviating the clinical manifestations of autoimmune diseases. Receives: Drug: F182112 single-agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event
Measured: 28 days post the last dose treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Shi, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Jun Shi, Principal investigator, Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical College Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816341
- Sponsor's protocol ID
- F182112-IIT-005
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of F182112 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT07816341
- Acronym / sponsor ID
- F182112-IIT-005
- Conditions
- Autoimmune Hemolytic Anemia
- Keywords
- Autoimmune Hemolytic Anemia, F182112
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Sep 2026 (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.
This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia | Experimental | Drug: F182112 single-agentF182112 is a recombinant humanized anti-BCMA/CD3 bispecific antibody for injection. By binding to CD3 receptors on T cells, F182112 can effectively deplete BCMA-expressing B cells and plasma cells in vivo, thereby alleviating the clinical manifestations of autoimmune diseases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Diagnosis of AIHA according to established Chinese or international criteria, including warm AIHA, mixed AIHA, cold agglutinin disease, or Evans syndrome.
- Refractory to multiple lines of therapy, meeting all of the following: HGB <100 g/L with evidence of hemolytic anemia; Prior treatment with ≥2 immunosuppressive therapies, including a CD20 monoclonal antibody; Glucocorticoid treatment for ≥3 months, unless contraindicated or intolerable; Adequate prior CD20 monoclonal antibody treatment (≥4 doses of 100 mg or 375 mg/m², or 2 doses of 1,000 mg).
- ECOG performance status ≤2.
- Participants and their partners agree to use effective contraception from informed consent through 1 year after study treatment.
Key exclusion criteria (19 listed)
- Diagnosed lymphoproliferative malignancy.
- Secondary AIHA caused by drugs or infection.
- Congenital immunodeficiency or other inherited or acquired hemolytic disorders.
- Prior organ or hematopoietic stem cell transplantation.
- New thrombotic events or organ infarction within 6 months before enrollment.
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 |
|---|---|---|
| F182112 single-agentThe dose-escalation phase will evaluate three sequential target dose levels of F182112: 30 μg/kg, 90 μg/kg, and 180 μg/kg, using a standard 3+3 design. F182112 will be administered intravenously using a priming dose followed by a target dose. | Drug | F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia |
Primary outcome
Incidence of adverse events
Time frame: 28 days post the last dose treatment
Use Common Terminology Criteria for Adverse Events (CTCAE) Version 6 to assess the adverse event
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 11 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Jun Shi principal investigator
Institute of Hematology & Blood Diseases Hosptial, Chinese Academy of Medical Science and Peking Union Medical College Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F182112 single-agent in people with Autoimmune Hemolytic Anemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site 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 6 inclusion and 19 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Lele Zhang (8602223908328, zhanglele@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 28 days post the last dose treatment). 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 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.